By:

K.L. Sharma, Joint Secretary to the Government of India,

Ministry of Health and Family Welfare
Presently, The quality, safety and efficacy of
notified medical devices manufactured, imported
and sold in the country are regulated under the
Drugs and Cosmetics Act, 1940. Under this
Central Act, medical devices are regulated as
drugs as defined in Section 3 (b) (iv) that:

“Such devices intended for internal or external

use in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human
beings or animals, as may be specified from
time to time by the Central Government by
notification after consultation with the Board”
S. No Name of the device SLA/CLAA Date of notification
1 Disposable Hypodermic Syringes SLA 17-03-1989

2 Disposable Hypodermic Needles SLA 17-03-1989

3 Disposable Perfusion Sets SLA 17-03-1989
4 In vitro Diagnostic Devices for HIV, HbsAg and HCV and SLA 27-08-2002
blood grouping sera

5 Cardiac Stents CLAA 06-10-2005

6 Drug Eluting Stents CLAA 06-10-2005

7 Catheters CLAA 06-10-2005
8 Intra Ocular Lenses CLAA 06-10-2005
9 I.V. Cannulae CLAA 06-10-2005
10 Bone Cements CLAA 06-10-2005
11 Heart Valves CLAA 06-10-2005
12 Scalp Vein Set CLAA 06-10-2005

13 Orthopedic Implants CLAA 06-10-2005

14 Internal Prosthetic Replacements CLAA 06-10-2005

15 Ablation Devices *CLAA 25-01-2016

3
Medical Device Rules, 2017 under the provisions of
the Drugs and Cosmetics Act, 1940 has been
published, vide GSR 78(E) dated 31.01.2017
proposed to be effected from 01.01.2018.

The said Rules shall override all the previous

notifications issued under the D&C Rules,1945
related to the regulations of medical devices.

The said rules have provisions for the regulation of

devices for their import, manufacture, clinical
investigation and sale.
New Rules shall be applicable to:

(i) substances used for in vitro diagnosis and surgical dressings,

surgical bandages, surgical staples, surgical sutures,
ligatures, blood and blood component collection bag with or
without anticoagulant covered under sub-clause (i) of section
3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
(ii) substances including mechanical contraceptives (condoms,
intrauterine devices, tubal rings), disinfectants and
insecticides notified under sub-clause (ii) of section 3 of the
Drugs and Cosmetics Act, 1940 (23 of 1940); and
(iii) devices notified from time to time under sub-clause (iv),
of clause (b) of section 3 of the Drugs and Cosmetics Act,
1940 (23 of 1940);
Chapter- I Title, Application, Commencement, Definition
Chapter - II Classification of MD, Grouping of MD, Essentials Principles

Chapter - III Authorities, delegation of powers, Notified bodies, Medical Devices Testing
Centres,
Chapter - IV Manufacture of MD-Application, Inspection, grant of lic, conditions of lic,
Suspension, Cancellation, Appeal, Test License
Chapter - V Import of MD-Application, Overseas Inspection, grant of lic, Test lic, Hospital
use, Personal use
Chapter - VI Labelling requirement
Chapter - Clinical Investigation- Permission, Medical management, Compensation,
VII Inspection
Chapter - Permission to import or manufacture medical device which does not have
VIII predicate medical device
Chapter -IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer
and Notified Body
Chapter -X Regulation of Laboratories for carrying test or evaluation
Chapter - XI Sale of Medical Devices
Chapter - Miscellaneous – Rejection of application, Debarment of applicant,
XII Exemptions
Schedule Number Title
First Classification of MD and IVD
Second Fee
Third Registration and functions of Notified Bodies
Fourth Documents required for grant of mfg and Import
licence

Fifth Quality Management System

Sixth Post Approval - Major and Minor Changes

Seventh Requirements to conduct Clinical Investigation

Eight Exemptions
Medical Device Rules, 2017 – Salient Points

New Definitions
Medical Device
Substantial Equivalence
Predicate device
Investigational Medical Device
New in-vitro diagnostic
Clinical Investigation
Notified Body
Clinical Performance Evaluation
• Medical devices shall be notified by the Central Government and
classified by the CLA based on the classification rules specified
in the First Schedule of the drafted rules.

• Following are the risk Classes and the classification criteria

based on the severity of risk associated with the medical device.

Risk Criteria Risk Class

Low Class A
Low-Moderate Class B
Moderate-High Class C
High Class D
 Device Class Class A Class B Class C Class D

Activity
Import Import
IMPORT Import Licence Import Licence
Licence Licence
*Manufactu
Manufacturin Manufacturing Manufacturing
MANUFACTURE ring
g License License License
License
CLINICAL
For an Investigational medical device, the applicant shall
INVESTIGATION
need to obtain Permission from CLA to conduct clinical
FOR
investigation of Class B, Class C and Class D
investigational
And
DEVICES and
Clinical Performance Evaluation of new IVDs
new IVDs
SALE Regulation as per Current D & C Rules
*Notified Notified Body CLA CLA
QMS Bodies
Verification by

* Licence will be issued without prior inspection...

 Device Class Class A Class B Class C Class D

Activity
IMPORT CLA CLA CLA CLA

MANUFACTURE SLA SLA CLA CLA

Permission to
conduct
CLINICAL Permission from CLA
INVESTIGATIO
N
SALE SLA

QMS *Notified *Notified Body CLA CLA

Verification by Body

*Note: Notified Bodies shall be registered with Central Licencing Authority.

Prior inspection shall not be required before the grant of
manufacturing of Class A devices.
Application for Import, Clinical Performance
evaluation of new IVD and manufacture of Class C
and Class D IVDs, test licence, Free Sale Certificate,
and personal use will be submitted to CLA through
online portal. Inspection of manufacturing site will
be carried out by Drugs Inspectors.

Application for sale, manufacture of Class A and

Class B devices will be submitted to SLA through
online portal. Audit of manufacturing site will be
carried out by Notified Bodies.
Only Class A and Class B medical Devices
To verify QMS conformance at manufacturing
site where necessary by inspection
Verification of Essential Requirements
Verifying validation of manufacturing process
through objective evidence
conformity of material with defined
specifications
Responsibility for ensuring conformance to QMS
and conditions of license/registration
State Licensing Authority to audit at least 2% of
the audits carried out and recommended for
grant of license by of each Notified Body.
Registered with CDSCO.
Accredited by National Accredited Body (such as
NABCB).
Procedures prescribed in schedules for
registration of notified bodies.
Schedule of fee to be charged by notified bodies.
Duties, functions and obligations of notified
bodies specified in the Third Schedule of the rules.
For Class A types of devices a minimum set of requirements as
specified in Part II (i) of the Forth Schedule.

For Class B, Class C and Class D types of devices a minimum set of

requirements as specified in Part II (ii) of the Forth Schedule.

Appendix I of Part III of the Fourth Schedule specifies requirements for

Site Master File.

Appendix-II and Appendix- III of Part III of the Fourth Schedule

specifies requirements for Device Master File.

Clinical investigation of investigational medical devices as per the

requirements of the Seventh Schedule.

For new IVDs- Technical Data requirements has been specified in

section (b) of Part IV of the Fourth Schedule.

Performance Evaluation of IVDs to establish specification, specificity,

sensitivity, etc. of all the IVDs shall be carried out at the medical device
testing laboratory registered under rule 83.
Licence shall remain valid, till it is suspended or cancelled from
its date of issue, provided the applicant pays a licence retention
fee in every five years.

Manufacturer shall be audited periodically.

No inspection prior to grant of manufacturing licence for Class A

devices.

Test licences shall be granted by Central Licencing Authority.

Provisions for loan licence.

For Regulators- Establishment or designation Govt. laboratories

for testing.

For Manufacturers- Testing laboratories registered under these

rules.
i. BIS or those set by Central Government
ii. Failing (i) by International Organisation
for Standardisation (ISO) or International
Electro Technical Commission (IEC)
iii. Failing both, manufacturers validated
standards.

17
Medical Devices which do not have a predicate device will
undergo through a clinical investigation to establish safety

Supervision by Ethics Committee as in case of Drugs.

Application to CLA with Clinical Investigation Plan.

Maintenance of investigation records.

Waiver in case of National Emergency.

Pilot Clinical investigation (to check feasibility on 3 to 5

patients)

Pivotal clinical investigation (on 10 to 50 patients)

18
Class A devices exempted from clinical
investigation.

Custom made devices are exempted from all

provisions.

Medicated Dressings, Mechanical Contraceptives,

bandages and disinfectants are exempted from
provisions of Sale.

Non-sterile components and raw material –

exempted from import licence.

Devices intended for charity – exempted from

import licence
19
Commencement from January, 01, 2018

Entire process of regulations shall be a single

through online portal

Guidance documents to the industry and

patients will be issued

To strengthen the regulatory system Medical

Devices officers will be recruited for carrying
out enforcement activities
Additional medical devices are to be notified
under the provisions of the D&C Act, 1940.

Classification of each of the devices will be

made available on the CDSCO website

Medical Devices Testing Centres for testing

Critical to Quality parameters of finished
devices
Overview of MD Regulation
in Japan
2nd Japan-India Medical Products
Regulation Symposium
April 2017
 History of PAL(regulations on MDs)
(1889 The first regulations of Medicines was stipulated)
1930 The first regulation on Medical Devices (Appliance for
contraception)
(1943 The establishment of the first Pharmaceutical
Affairs Law(PAL). MDs were not included)
1948 Full revision of the First PAL. (MDs were included)
It is used to clear harmful medicines and devices . Like police
1960 Full revision of the PAL
This is the base of the PAL we used.
- Licensing system for manufacture/ import of each product
1979 Strengthen assurance of safety, efficacy and quality and help
for side effects.
1993 Introducing Promotion of Research and Development.
1994 Improvement of Medical device regulations.

2
 History of medical device regulations in Japan
– recent big amendments (1/2)

Medical Device has been regulated in Japan since 1960,

and there have been 2 big amendments for the
regulations recently;

1.Amendment in 2005
① Introduction of Marketing Authorization Holder system
② Introduction of Registered Certification Body system
③ Introduction of medical device classification based on
the GHTF classification rule
④ Introduction of STED and Essential Principles
⑤ Introduction of GCP as a ministerial ordinance
⑥ Introduction of QMS, instead of GMP

3
 History of medical device regulations in Japan
– recent big amendments (2/2)

Medical Device has been regulated in Japan since 1960,

and there have been 2 big amendments for the
regulations recently;

2.Amendment in 2014
① Amendment of Registered Certification Body system,
including expansion of scope
② Improvement of regulations on manufacturer
③ Improvement of QMS inspection
④ Application of medical device regulations on SaMD
(Software as a Medical Device)
⑤ Establishment of a new category, Regenerative
Medicine Product

4
 - Regulatory Authorities in Japan -
MHLW PMDA
Ministry of Health, Labor and Welfare Pharmaceuticals and Medical Devices Agency

Final Authorization of
applications Scientific Review for
Drugs & MD
Publishing Guidelines
GCP, GMP Inspection
Advisory committee
Consultation on Clinical
Supervising PMDA Trials etc.
Activities

5
Scope of regulations on medical device/IVD
marketing in Japan under PMD Act

Minister’s Approval for marketing

Product or Certification by a Registered Certification Body
or Marketing Notification

Company License of Marketing Authorization Holder (MAH)

Manufactur
Registration as a Manufacturer
ing facility

License/notification/self declaration of selling

Distributor Medical devices

Repairer License of repair Medical devices

PMDA-ATC Medical Devices Seminar
2016

6
 Medical Device Regulations in Japan

Classification Class I Class II Class III Class IV

General Controlled
Category Specially controlled MDs
MDs MDs
Self- Third party PMDA review
Review regulation
declaration certification ( MHLW approval )

Example

Post market safety

( vigilance/surveillance PMDA and MHLW
)

7
COMPANY/ MANUFACTURING FACILITY
REGULATION

8
 MAH License : From local government
MAH Need for
1. Having marketing supervisor general,
QMS safety management supervisor and
quality assurance supervisor
2. Having system for GVP
Manufacturer 3. Having system for QMS
(They should follow QMS and GVP when
they market products)

Manufacturer : JUST register

(They should follow QMS when they
Manufacturer manufacture products)

Since 2014

9
 Example of manufacturing site registration

Outside of Japan In Japan

Design & Sub-

Supplier Main Assembly Packing Distribution
Development Assembly

Release
to the market

Registration
Required Not Required Not Required Required Not Required Required

10
Type of QMS Inspection
Application
for approval Approval

Regulatory
R&D Marketing
Review

Every 5 years

Pre-approval Post-approval
Post-approval
inspection inspection inspection
• One of the requirements for marketing • Conducted every five years after
approval of medical device marketing approval

• Based on application
• Conducted per Product Family
11
QMS Inspection Authority

Product Inspection Authority

• Class IV
• New medical devices
PMDA
• Cell / Tissue-based medical
devices
Medical
Devices • Class III and Class II
PMDA
(without CS*)
• Class III and Class II (with
Registered certification body
CS*)
• New drugs
PMDA
• Radioactive drugs
IVDs • Products without CS* PMDA
• Products with CS* Registered certification body
*CS : Certification Standards
12
PRODUCT REGULATION

13
Approval/Certification system in Japan
Product
Approval/Certification Requirements
Quality, Efficacy & Safety of Products
QMS-Compliance

Marketing Marketing
Approval Approval/ Product Release
Application Review & Certification (Post-marketing
Inspection surveillance, outcome
examination etc.)

Licensed Marketing
Registered
Authorization Holder
Manufacturer
(MAH)

Requirements
Requirements
Governance
Governance
GVP-Compliance

14
 Regulation according to Risk Based
Classification of Medical Device in Japan
As of March, 2016
GHTF Classification Classification in Japan
Category Pre-market # of JMDN*
regulation
Class extremely low General MDs Self 1,195
A risk (Class I) declaration
X-Ray film
Class low risk Controlled MDs Third party 1,972
B MRI, bronchial (class II) Certification
catheters

Class medium risk

Specially 771
C artificial bones, Minister’s
dialyzer Controlled MDs Approval
Class high risk (class III & IV) (Review by
350
D pacemaker, artificial PMDA)
heart valves

*JMDN: Japanese Medical Device Nomenclature

15
 Outline of brand-new medical device
approval review process
Applicant
Consultatio Application
n

PMDA MHLW
Conformity Audits Advisory body
( GLP/GCP/QMS etc. ) PAFSC
+
Scientific Reviews Consultation Advice
Consultation Advice Revie
w
Report Minister
External
Experts

PAFSC: Pharmaceutical Affairs and Approval

Food Sanitation Council

16
 Review Time of Brand-new Medical
Devices
Priority items

FY 2010 2011 2012 2013 2014 2015

Target 16 15 13 10 10 10
(50th (50th (50th (50th (60th (60th
(months) percentile) percentile) percentile) percentile) percentile) percentile)

Performance 15.1 4.3 9.3 9.0 8.8 7.9

(months)
# 3 6 5 14 5 8
Normal items
FY 2010 2011 2012 2013 2014 2015
Target 21 20 17 14 14 14
(50th (50th (50th (50th (60th (60th
(months) percentile) percentile) percentile) percentile) percentile) percentile)

Performance 16.5 9.7 12.7 6.3 5.6 10.1

(months)
# 15 27 41 80 62 48 17
Third party certification process in Japan
A Certification issued by a registered certification body is
required for Class II/III MDs/IVDs that have technical
standards for certification before their marketing.

(1)
Applicant Certification
(Marketing Application
Authorization
(2) Certification Bodies
Holder)
registered with MHLW
Manufacturer
(4) Follow-up On-site inspection
and/or
inspection
document review

MHLW
(3) Certified product report
(Monthly)

18
 Registration and Supervision of certification
body
Registration
MHLW 2. Ask for assessment
5. Registration
PMDA
of Certification
Body 4. Report assessment result

1. Apply for registration with 3. Document review and On-site assessment;

identification of scope of
medical device
conformity to the following requirements
(with no fee) - ISO/IEC 17065: 2012
- ISO/IEC 17021: 2011

Certification body
Supervision of registered certification
body
- PMDA perform annual on-site
surveillance.
- Registration has to be renewed every 3 19

years.
(Reference) List of Certification Standards for
Third Party Certification

20
 Number of Certification Standards As of March, 2017
For class II MDs 935
For class III MDs 11
Class III MD Certification Standards for Issued on
Pen type infector for insulin 25 November 2014
Blood filter and bubble eliminator for artificial
25 November 2014
cardiopulmonary circuit with heparin
Infusion pumps 25 March 2015
Manual type lung resuscitator 30 September 2015
Electrosurgical unit with substances 18 November 2015
Monitors such as Arrhythmia monitoring system 18 November 2015
Non-absorbed thread 24 December 2015
CPAP 24 December 2015
Self Measuring device for blood glucose 30 March 2016
Navigation system for neurosurgery 18 November 2015

21
Number of approvals of Medical Devices

FY2010 FY2011 FY2012 FY2013 FY2014

Medical devices (total) 1,634 1,227 1535 1,347 1,235

Priority review items

3 6 5 14 5
(included in total)

Band-new MDs 18 33 46 94 67
Breakdown

Others (e.g. Improved

MDs w/wo clinical 1,616 1,194 1,489 1,253 1,168
data, Me-too MDs)

Number of certifications by registered certification bodies

Certification (including 2,298 2,369 2,350 2,417 2,276
partial change
certification)

22
Recent measures taken related to medical
device regulations in Japan

23
Implementation of PMD Act; Revision of Pharmaceutical Affairs
Law (PAL)

The PMD Act came into force on 25 November 2014 for the
purpose of:
1. Strengthening safety measures regarding drugs and medical
devices
2. Revising medical device regulations based on its characteristics
3. Introducing cellular and tissue therapeutic product regulations
based on its characteristics

According to the revision:

a. Some Class III Medical Devices undergo certification
b. Software as a Medical Device (SaMD) is newly regulated
c. Manufacturer is required to be registered, instead of to be
licensed
d. More efficient QMS inspection system is introduced

24
 Establishment of new international regulatory
harmonization strategies by MHLW and PMDA

International Regulatory Harmonization Strategy by MHLW and

PMDA International Strategic Plan 2015 by PMDA have been
published on 26 June 2015.
Based on the mutually complementary strategies, the following
measures will be taken:
A) Promotion of Regulatory Science
Guidelines related to medical device regulations in Japan will be prepared and
internationally announced.

B) Establishment of Training Center for regulatory matters

PMDA will provide regulators outside Japan with training for capacity building.

C) Active commitment to IMDRF as well as advancement of bilateral

collaboration

25
 Official Participation in MDSAP
Japan made an announcement on the official participation in
MDSAP Pilot on 23 June 2015.
Further information will be provided in a timely manner.

Shown at right is the press

release on the official
participation in MDSAP Pilot in
Japan
(written in Japanese).

You can find the announcement

in English here;
http://www.fda.gov/MedicalDevic
es/InternationalPrograms/MDSA
PPilot/ucm452243.htm

26
 Implementation of Strategy of Sakigake
An innovative MD/IVD for patients in urgent need of innovative
therapy may be designated as a Sakigake Product if;
1) its premarket application will be filed in Japan firstly or
simultaneously in some countries including Japan, AND
2) prominent effectiveness can be expected.

Once an MD/IVD is designated, its developer can enjoy such

benefits as:

A) Prioritized Consultation by PMDA C) Prioritized Review

(12 months 6 months [MD])

B) Pre-application substantive review D) Review Concierge assigned

by PMDA

27
Designation of Sakigake products
As of 28 February 2017, 7 more products (3 medical devices, 1 IVD and 3
regenerative medicines) have been designated as Sakigake products.

No. Product name Expected performance/effectiveness

Artificial tracheal Aiding reconstruction of tracheal while
MD
(made of polypropylene mesh maintaining intratracheal structure after partial
3
and collagen sponge) removal.
Boron neutron capture therapy
MD (BNCT) system Selective destruction of tumor cells marked by
4 (Neutron irradiation system for boron agents, without damaging normal cells.
BNCT)
UT-Heart
(Software program to aid Higher accuracy of prediction of effectiveness of
MD
prediction of effectiveness of cardiac resynchronization therapy for patients
5
cardiac resynchronization with serious heart failure.
therapy)
Cancer-related gene panel
IVD examination system Collective examination of cancer-related genes to
1 (Diagnostic system for DNA aid decisions on cancer treatment strategies
sequencer)
No. Product name Expected performance/effectiveness
CLS2702C/D Shorter re-epithelialization period after extensive
RP4 (Oral mucosa-derived endoscopic submucosa dissection (ESD) in
esophageal cell sheet) esophageal cancer.
Dopamine neural precursor
cell derived from non- Novel therapy by inducing dopamine discharge to
RP5 autologous iPS cell mitigate neural symptoms of patients with
(Therapeutic stem cell for Parkinson’s disease.
Parkinson’s disease)
Pluripotent progenitor cell
derived form human
Novel therapy for improving functional
RP6 (allogeneic) adult bone marrow
impairment caused by acute brain infarction.
(Stem cell suspension derived
from adult marrow)

✧ Meanwhile, the absorbing barrier for adhesion prevention (MD2) which

was designated last year will be withdrawn, due to the termination of
development by the manufacturer.
(Reference) Designation of Sakigake products in 2016
The following 5 products under development have been designated as
Sakigake products since 10 February 2016.
If a pre-market application for the products is filed, a priority review is
applied.
No. Product name Expected performance/effectiveness

MD1 Titanium Bridge Adduction-type spasmodic dysphonia

(Hinge-type plate with titanium)

Absorbing barrier for adhesion Reduction of postoperative adhesion prevention by

MD2 prevention Intraperitoneal injection
(Trehalose solution)

STR01 Improvement of neurological symptoms and functional

RP1
(Autologous bone marrow-derived stem cells) impairment due to spinal cord injury

RP2 G47Δ Glioma

(Recombinant herpes virus)

Improvement of heart function in children with

RP3 Autologous intracardiac stem cells
congenital heart disease
Examination relating to the early implementation of medical devices for which there are high medical
needs
Call for requests* for early implementation of medical devices for which At Academic
there are high medical needs Societies, etc.
Call for requests for medical devices, etc. that correspond to the *Conducted since 2006
selection criteria at academic societies, etc.

Evaluation of medical necessity

Examination meeting on early
Working Group
(Established for each diagnosis and implementation of medical devices etc.
treatment department) for which there are high medical needs

* Examination meetings, based on periodical reports from the Ministry of Health, Labour
and Welfare, aiming for early approval of applications, provide:
Call for companies ・Advice for early implementation (necessity for academic society guidelines, etc.)
to conduct development ・Opinions on appropriateness for early implementation
・Development requests ・Advice on post-market safety policy
* Also offer necessary advice for after application, in examination meetings, based on
reports of review progress situation.

Approval application Priority review etc. by Approval by Minister of Health,

Post-market safety
by company PMDA Labour and Welfare
policy
Selection criteria: Medical devices, etc. that fulfill one of the conditions a) to c) below:
a) Items for which there is a request from an academic society, etc.
Cooperation from
b) Items which have been approved in Europe or the U.S. or medical devices which have not been approved in Europe
or the U.S. that fulfill certain conditions* academic societies, etc.:
*Medical devices which have not been approved in Europe or the U.S. but fulfill one of the conditions (1) to (3) below: ・Cooperation with post-
(1) Items for which excellent clinical trial results have been released as a paper, etc. (2) Items for which doctor-led market clinical trials, etc.
trials have completed or are being conducted. (3) Items with a certain level of results as Advanced Medicine B. ・Ensuring appropriate
c) Items for which there are recognized to be particularly high medical needs: use (facility requirements,
(1) Seriousness of diseases to which it is to be applied. training, etc.)
(2) Medical usefulness.
4
Next-generation medical devices and regenerative medicine,
etc. product evaluation criteria
Objective:
To seek to accelerate approval reviews and improve efficiency of product
development by preparing in advance and releasing the technology evaluation
criteria, etc. to be used in reviews for next-generation medical devices with high
medical needs and practical applicability, to enable to rapid provision to the
medical workplace of medical devices and regenerative medicine products that
use diverse cutting-edge technologies including IT, biotechnology, etc.

(2) Acceleration of reviews by

Min. of Health, Labour and
(1) Acceleration of development Welfare & PMDA
Points for increasing by companies
speed and
smoothness Use of pre-application and
pre-trial consultation system

Flow from Design & Safety trials Clinical trials Application Approval
development development Performance trials
to approval

5
 Evaluation criteria released until now (1/2)
Medical device review management office
Field Evaluation criteria classification
notification name
Pharmaceutical and Food Safety Bureau 0404002,
Active in vitro medical devices Clinical evaluation of next-generation high performance artificial hearts issued on Apr. 4, 2008.

Clinical evaluation of medical devices for treatment of critical limb Pharmaceutical and Food Safety Bureau 0529 No.
Critical limb ischemia 1, issued on May 29, 2013.
ischemia
Pharmaceutical and Food Safety Bureau 0404002,
DNA judgment diagnostics using DNA chips issued on Apr. 4, 2008.
Tailor-made medical
diagnostic devices Pharmaceutical and Food Safety Bureau 1120 No.
Diagnostic equipment based on RNA profiling 5, issued on Nov. 20, 2012.
Pharmaceutical and Food Safety Bureau 0118 No.
Diaplasis support equipment 1, issued on Jan. 18, 2010.
Pharmaceutical and Food Safety Bureau 0118 No.
Joint surgery support equipment 1, issued on Jan. 18, 2010.
Navigation medicine Pharmaceutical and Food Safety Bureau 0528 No.
Computerized surgery support equipment for application to soft tissue 1, issued on May 28, 2010.
Custom-made orthopedic implants, etc. made from 3D laminated Pharmaceutical and Food Safety Bureau Council
structure technology using patient image data 0925 No. 1, issued on Sep. 25, 2015.

Pharmaceutical and Food Safety Bureau 0118 No.

Cell sheets for cell therapy for serious heart failure 1, issued on Jan. 18, 2010.
Pharmaceutical and Food Safety Bureau 0118 No.
Cell sheets for corneal epithelium 1, issued on Jan. 18, 2010.
Pharmaceutical and Food Safety Bureau 0528 No.
Cell sheets for endothelium of cornea 1, issued on May 28, 2010.
Pharmaceutical and Food Safety Bureau 1215 No.
Articular cartilage regeneration 1, issued on Dec. 15, 2010.
Pharmaceutical and Food Safety Bureau 1207 No.
Cell sheets for periodontal tissue treatment 1, issued on Dec. 7, 2011.

Regenerative medicine Pharmaceutical and Food Safety Bureau 0529 No.

Self-iPS cell derived retinal pigment epithelial cells 1, issued on May 29, 2013.
Pharmaceutical and Food Safety Bureau Council
Same-type iPS cell derived retinal pigment epithelial cells 0912 No. 2, issued on Sep. 12, 2014.
Pharmaceutical and Food Safety Bureau Council
Nasal cartilage regeneration 0925 No. 1, issued on Sep. 25, 2015.
Articular cartilage regeneration using human cartilage cells or somatic Pharmaceutical Safety and Environmental Health
stem processing Bureau 0630 No. 1, issued on Jun. 30, 2016.

Articular cartilage regeneration using human (same-type) iPS cell

Pharmaceutical Safety and Environmental Health 6
processing Bureau 0630 No. 1, issued on Jun. 30, 2016.
 Evaluation criteria released until now (2/2)
Medical device review management office
Field Evaluation criteria classification
notification name

Neural function Pharmaceutical and Food Safety Bureau

Neural function modification equipment 1215 No. 1, issued on Dec. 15, 2010.
modification equipment
& activity function Pharmaceutical and Food Safety Bureau
Activity function recovery equipment 0529 No. 1, issued on May 29, 2013.
recovery equipment
Custom-made bone connecting material implants for Pharmaceutical and Food Safety Bureau
orthopedic use 1215 No. 1, issued on Dec. 15, 2010.

Pharmaceutical and Food Safety Bureau

Custom-made artificial hip joints for orthopedic use 1207 No. 1, issued on Dec. 7, 2011.
Pharmaceutical and Food Safety Bureau
Custom-made artificial knee joints for orthopedic use 1120 No. 5, issued on Nov. 20, 2012.
In vitro materials
Pharmaceutical and Food Safety Bureau
Spine implants to maintain mobility and stability Council 0912 No. 2, issued on Sep. 12, 2014.

3D laminated structure technology using orthopedic Pharmaceutical and Food Safety Bureau
implants Council 0912 No. 2, issued on Sep. 12, 2014.

Computer diagnostic Pharmaceutical and Food Safety Bureau

Computer diagnostic support equipment 1207 No. 1, issued on Dec. 7, 2011.
support equipment

Cardiac catheter Pharmaceutical and Food Safety Bureau

Cardiac catheter ablation equipment Council 0925 No. 1, issued on Sep. 25, 2015.
ablation

Pharmaceutical Safety and Environmental

Stents Bio-absorbable heart stents Health Bureau 0630 No. 1, issued on Jun. 30,
2016.

Release of next-generation medical devices evaluation criteria:

(Notifications addressed to each Prefecture’s Director of Health and Safety after public comment and reporting to the
Pharmaceutical and Food Safety review committee) http://dmd.nihs.go.jp/jisedai/tsuuchi/index.html
7
 Concept of reviews: New Thinking

It is demanded to reconsider the balance between patient’s timely

access to MDs and considerable amount of time required to
conduct clinical trials in order for much more robust evidence.
As well as the balance of risk and benefit in reviews, examination
is also required regarding the balance of what should be required
in pre- and post-market stage.
⇒ Guidance on the number of cases for clinical trials, Fast
Break Scheme for innovative medical devices.

Risk
＋
Benefit

Speed of Solid
patient access evidence
17
<Support for accelerated approval for innovative
Medical device
Fast Break Scheme
~Importance for system
of approval Innovative MD（Draft）
encouraging
medical venture~>
Innovative MDs created by medical venture enterprises
are expected to have extremely effective and safe profile,
however, these MDs tend to target extremely few patients.
In that case, the development might be stagnated
because of difficulties in collecting cases for clinical trial.
Considering such a situation and our mission to
introduce innovative MDs to the public the government
should construct
From the Report theforscheme
by Conference promotion ofwhich accelerate
Venture companies driving the
clinical innovations
The scope innovative
approval of the scheme
Subjects the to be solves MDs by minimizing
【example image the burden
of target MD】
The wayclinical
regarding of pre-market
trials and enhancing the post-market
review
surveillance. with limited number
of clinical cases, overseas
data and literature
Post-market safety
monitoring system which EXCOR Pediatric (Ventricular
enables accelerated assist device for pediatric)

approval …etc.
 Single-use Medical Device (SUD) Reprocessing
Backed by the high interest in SUD reprocessing, currently carried out in
an orderly manner in such countries like the US and Germany etc.,
Japan is now studying its appropriate implementation, since it could give
great benefits of saving materials, reducing wastes and suppressing
medical costs.
After organizing a Study Group in FY 2015, the following investigations
have been conducted, in order to identify
the issues and to develop implementation guidelines.
1) Actual regulatory situations (US, Germany, UK)
2) Domestic needs for reprocessed SUD
Relevant regulations will be streamlined in FY 2017 for the proper
implementation of SUD reprocessing, and studies are on-going to
establish criteria for the quality of reprocessed SUD, and for the
reprocessing quality control.
③Cleaning, Parts ④Assembly, Inspection,
②Receiving Replacement Labeling, Packaging

① Recovery from
Medical Institutions ⑤Sterilization,
Shipping
Thank you!
Third party certification system
and
Certification standard in japan

Katsuhisa Ide
Division of Standards for Medical Devices
Office of standards and Guidelines Development

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Today’s Agenda

1. Introduction
a. PMDA, Office of Standards and Guidelines Development
2. Utilization of Standards in review process in Japan
a. Framework for Certification Standards, Approval Standards and Review
Guideline
b. Certification Standards
c. Approval Standards and Review Guideline
d. Process of development for Certification Standards ,etc.
3. Our Website for Standards regarding Medical Devices

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Today’s Agenda

1. Introduction
a. PMDA, Office of Standards and Guidelines Development
2. Utilization of Standards in review process in Japan
a. Framework for Certification Standards, Approval Standards and Review
Guideline
b. Certification Standards
c. Approval Standards and Review Guideline
d. Process of development for Certification Standards ,etc.
3. Our Website for Standards regarding Medical Devices

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Who We are ?

Who we are：
PMDA (Pharmaceuticals and Medical
Devices Agency) is a Japanese regulatory
agency, working together with the
Ministry of Health, Labour and Welfare.
Our obligation is to protect public
health by assuring the safety, efficacy
and quality of pharmaceuticals and
medical devices.

Please refer to the following website for details

Date of establishment: April 2004 https://www.pmda.go.jp/english/index.html)

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 PMDA Organization
Office of Review Administration
Office of Review Management
Office of Standards and Guidelines
Development※
Office of Medical Devices I-III
Office of Vaccines and Blood Products
Office of Cellular and Tissue-based Products
Office of Generic Drugs
Office of OTC/Quasi-drugs
Office of New Drug I-V
Office of Non-clinical and Clinical
Compliance

※ We focus on developing standards and guidelines

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 PMDA Organization

Office of Standards and Guidelines Development

Division of Pharmacopoeia and Standards for Drugs

・Secretariat of Japanese Pharmacopoeia Expert committees

・Registration of Master Files for Drug Substances

Division of Standards for Medical Devices

・Secretariat of Committees for Certification and Approval Standards

・Cooperation to establishment of JIS, ISO and IEC standards
・Open these standards to the public in a timely manner.

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Today’s Agenda

1. Introduction
a. PMDA, Office of Standards and Guidelines Development
2. Utilization of Standards in review process in Japan
a. Framework for Certification Standards, Approval Standards and Review
Guideline
b. Certification Standards
c. Approval Standards and Review Guideline
d. Process of development for Certification Standards ,etc.
3. Our Website for Standards regarding Medical Devices

The 2nd Japan-India Medical Products Regulation Symposium 2017

7
 Framework of Standards in Japanese regulation
PMD Act classification
GHTF Classification Category Regulatory requirements Japanese MD
Nomenclature
Class A Extremely low risk General MDs Self declaration 1,196
e.g., (Class I) Approval of the product is
X-ray film not required, but marketing
notification is necessary.
Class B Low risk Third party Certification 1,974
e.g., MRI, Controlled MDs Certification by a registered (1,518 for 3rd
digestive (class II) certification body is required. Party)
catheters ・Certification Standard

Class C Medium risk 778

Minister’s Approval
e.g., dialyzer Specially (43 for 3rd
(Review by PMDA)
Controlled MDs Party)
The Minister's approval for
(class III & IV)
Class D High risk the product is required. 354
e.g., pacemaker ・Approval Standard
・Review Guideline
As of March, 2017
The 2nd Japan-India Medical Products Regulation Symposium 2017

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 How we control the quality of certification body
Registration
2. Ask for assessment
MHLW
5. Registration of PMDA
Certification Body
4. Report assessment result

1. Apply for registration with

identification of scope of
medical device 3. Document review and On-site assessment;
(with no fee) conformity to the following requirements
- ISO/IEC 17065: 2012
- ISO/IEC 17021: 2011
Certification body

Supervision of registered certification

body
- PMDA perform annual on-site surveillance.
- Registration has
The 2to be renewed
nd Japan-India Medical every 3 years.Symposium
Products Regulation 2017 9
 Certification Standards

Certification Standards (Third party Certification)

The “Certification Standards” are specified by the MHLW.
Registered third-party certification bodies※ utilize these standards to confirm
the conformity of Class II or III medical devices to the technical requirements.
※ Third-party certification bodies are requested to satisfy ISO/IEC 17021 and
ISO/IEC 17065

1) Regarding Class II medical devices

⇒ 935 Certification Standards have already been developed
which cover 1518 of 1974 Class II products. (77%)

2) Regarding Class III medical devices <New Activities since 2014>

⇒ The scope of third party certification was expanded to class III
⇒ 11 Certification Standards have already been developed which cover 43
Class III JMDNs.
※ As of March.2017

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Third party certification process in Japan
A Certification issued by a registered certification body is
required for Class II/III MDs/IVDs that have technical standards
for certification before their marketing.

(1) Application
Applicant Certification Bodies
(Marketing
Authorization registered with MHLW
Holder)
(2) Certification

Manufacturer On-site inspection

(4) Follow-up inspection
and/or
document review

MHLW
(3) Certified product report (Monthly)
The 2nd Japan-India Medical Products Regulation Symposium 2017

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How we control the quality of submissions and
review of Third Party Certification

Manufacturers Certification Bodies

Demonstrate and assess the Review and evaluate the
conformity of their device conformity of the
to essential principles with Certification submitted device to
identified standards in the Certification Standards
relevant Certification
Standards
Standards (JMDN specific)

The 2nd Japan-India Medical Products Regulation Symposium 2017 12

 Certification Standards (Class II)
Structure of Certification Standards
1. JMDN
Certification Standards are Notified by the MHLW .
Related applicable Japanese Medical Device Nomenclature (JMDN) are also listed.
2. Technical standard
Japanese Industrial Standard (JIS) is cited in principle.
Together with the EP check list including applicable standards to be used for conformity
assessment.
3. Scope of Purpose of use and effect
The purpose of use and effect for a medical device are determined based on its definition
given in the relevant technical standards.
Compliance with Essential Principles
All medical devices are required to satisfy the essential principle that align with those defined in
GHTF/SG1/N68:2012. A checklist of conformity to the Essential Principles is basically defined
and published notification.
Substantially Equivalent to Existing Product
Products subject to compliance with Certification Standards are limited to those which have
substantially equivalent to existing controlled medical devices

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Certification Standards (Class II)

Certification Standard is consisted

of
JIS and purpose of use and effect.
Structure of Certification Standards
Nomenclature of Applicable Medical Certification Standard
No.
Devices (JMDN) JIS Purpose of use and effect
1 1. X-ray system, diagnostic, T 0601-1-3 To provide the imaging information of human
general-purpose, mobile, Z 4751-2-54 body for medical care used with the
analogue scintillation effect, photo-effect or ionization
2. X-ray system, diagnostic, effect that X-ray went through a body has.
general-purpose, portable,
analogue
3. X-ray system, diagnostic,
JIS required by technical requirement
general-purpose, portable,
digital JIS T 0601-1-3 is based on IEC 60601-1-3:2008 (IDT)
4. X-ray system, diagnostic,JIS Z 4751-2-54 is based on IEC 60601-2-54:2009 (MOD)
general-purpose, stationary,
analogue
5. X-ray system, diagnostic,
general-purpose, stationary,
digital The 2nd Japan-India Medical Products Regulation Symposium 2017
6. X-ray system, diagnostic,
general-purpose, mobile,
digital

14
 Certification Standards (Class II)

Essential Principles Checklist

A checklist of conformity to the Essential Principles is basically published as notification.
Essential Principles of Safety and Identity of Specific
Applicable Method of Conformity
Performance of Medical devices Documents
１.General requirements
(Design) Applicable Show the conformity Ordinance on Standards for Manufacturing Control
Clause 1 with recognized standard and Quality Control of Medical
Medical devices should be designed and included requirements Devices and In Vitro Diagnostic Reagents（MHLW
manufactured ・・・・・・ Ministerial Ordinance No. 169 in 2004）

Show risk management JIS T 14971:「Medical devices -- Application of risk

is management to medical devices」
conducted according
to recognized standard
（Risk management） Applicable Show risk management JIS T 14971:「Medical devices -- Application of risk
Clause 2 is management to medical devices」
The solutions adopted by the conducted according
manufacturer ・・・・・・ to recognized standard
：
(Effective for medical devices) Applicable verify the effective to JIS T 14971:「Medical devices -- Application of risk
Clause 6 conduct risk analysis. management to medical devices」
All known and foreseeable risks,
and ・・・・・・ Show the conformity JIS Z 4751-2-54:2012:「Particular requirements for
with recognized the basic safety and essential performance of X-
Standard ray equipment for radiography and radioscopy
to verify the effective 203.6.3.2.101 , 203.6.4.3, 203.6.4.7., etc.
The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Certification Standards (Class II)

Essential Principles Checklist

A checklist of conformity to the Essential Principles is basically published as notification.
Essential Principles of Safety and Identity of Specific
Applicable Method of Conformity
Performance of Medical devices Documents
１.General requirements
(Design) Applicable Show the conformity Ordinance on Standards for Manufacturing Control
Clause 1 with recognized standard and Quality Control of Medical
Medical devices should be designed and included requirements Devices and In Vitro Diagnostic Reagents（MHLW
manufactured ・・・・・・ Ministerial Ordinance No. 169 in 2004）

Show risk management JIS T 14971:「Medical devices -- Application of risk

is management to medical devices」
conducted according
to recognized standard
（Risk management） Applicable Show risk management JIS T 14971:「Medical devices -- Application of risk
Clause 2 is management to medical devices」
The solutions adopted by the conducted according
Identity of Specific Documents
manufacturer ・・・・・・ to recognized standard
MHLW Ministerial Ordinance
(Effective for medical devices)
No. 169 is based on： ISO 13485：
Applicable verify the effective to JIS T 14971:「Medical devices -- Application of risk
2003Clause 6 conduct risk analysis. management to medical devices」
JIS TAll
and
known and foreseeable risks,
14971
・・・・・・ is based on ISO 14971:2007 Show
(IDT)the conformity JIS Z 4751-2-54:2012:「Particular requirements for
with recognized the basic safety and essential performance of X-
Standard ray equipment for radiography and radioscopy
to verify the effective 203.6.3.2.101 , 203.6.4.3, 203.6.4.7., etc.
The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Certification Standards (Class II)

Essential Principles Checklist

A checklist of conformity to the Essential Principles is basically published as notification.
Essential Principles of Safety and Identity of Specific
Applicable Method of Conformity
Performance of Medical devices Documents
１.General requirements
(Design) Applicable Show the conformity Ordinance on Standards for Manufacturing Control
Clause 1 with recognized standard and Quality Control of Medical
Medical devices should be designed and included requirements Devices and In Vitro Diagnostic Reagents（MHLW
manufactured ・・・・・・ Ministerial Ordinance No. 169 in 2004）

Show risk management JIS T 14971:「Medical devices -- Application of risk

is management to medical devices」
Identity of Specific Documents conducted according
to recognized standard
JIS Z（Risk
4751-2-54:2012
management） is based on IEC 60601-2-54:2009
Applicable Show risk management(MOD)
JIS T 14971:「Medical devices -- Application of risk
Clause 2 is management to medical devices」
The solutions adopted by the conducted according
manufacturer ・・・・・・ to recognized standard
：
(Effective for medical devices) Applicable verify the effective to JIS T 14971:「Medical devices -- Application of risk
Clause 6 conduct risk analysis. management to medical devices」
All known and foreseeable risks,
and ・・・・・・ Show the conformity JIS Z 4751-2-54:2012:「Particular requirements for
with recognized the basic safety and essential performance of X-
Standard ray equipment for radiography and radioscopy
to verify the effective 203.6.3.2.101 , 203.6.4.3, 203.6.4.7., etc.
The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Framework of Standards in Japanese regulation
PMD Act classification
GHTF Classification Category Regulatory requirements Japanese MD
Nomenclature
Class A Extremely low risk General MDs Self declaration 1,196
e.g., (Class I) Approval of the product is
X-ray film not required, but marketing
notification is necessary.
Class B Low risk Third party Certification 1,974
e.g., MRI, Controlled MDs Certification by a registered (1,518 for 3rd
digestive (class II) certification body is required. Party)
catheters ・Certification Standard

Class C Medium risk 778

Minister’s Approval
e.g., dialyzer Specially (43 for 3rd
(Review by PMDA)
Controlled MDs Party)
The Minister's approval for
(class III & IV)
Class D High risk the product is required. 354
e.g., pacemaker ・Approval Standard
・Review Guideline
As of March, 2017
The 2nd Japan-India Medical Products Regulation Symposium 2017

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Framework of Standards in Japanese regulation

(Technical and Essential Principle ,etc)

Regulatory Requirements

Certification Approval Review Review

Standards Standards Guideline A Guideline B

Third party Certification Minister’s Approval by reviewing PMDA

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Process for Certification Standards, etc..

② Secretariat
Industrial PMDA
Association Office of Standards MHLW
WG in Industrial Association

Medical Device Approval Std.

Pharmaceutical affairs and

Deliberation Committee
Certification Std.

Food Sanitation Council

Public comment

Notification
Committee
Approval Std.

Standard

JFMDA
Review Guideline

①
Contact
PMDA
Division of Standards ① PMDA Office of standards contact and discuss with industrial , MHLW
for Medical Devices and internal PMDA regarding the contents for standards.

② PMDA Office of standards hold a Deliberation Committee as secretariat.

Academia, consumer(medical doctor), industrial attends as a delegate.

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Today’s Agenda

1. Introduction
a. PMDA, Office of Standards and Guidelines Development
2. Standards and regulation
a. Standards
b. Standards used in regulation
3. Utilization of Standards in review process in Japan
a. Framework for Certification Standards, Approval Standards and Review
Guideline
b. Certification Standards
c. Approval Standards and Review Guideline
d. Process of development for Certification Standards ,etc.
4. Our Website for Standards regarding Medical Devices

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Our website for standards for Medical
Devices
We open these standards to the public by English.
Please visit our Website ： http://www.std.pmda.go.jp/stdDB/index_e.html

The 2nd Japan-India Medical Products Regulation Symposium 2017

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List of Certification Standards

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 As a summary

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 Summary
Use International Standards for regulatory purposes
Regarding low risk devices with Certification Standards, the
review is conducted by third party instead of PMDA.
As for some of high risk devices, Approval Standards or
Review Guideline for review process are notified by MHLW.
All medical devices has to conform the Essential Principle
(EP) and those EP using International Standards as well as JIS
JIS is mostly based on ISO and IEC
→It can be said the translation version of ISO/IEC.

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Summary

Utilization of international Standards in regulation may make

win-win-win situation for both Industries-regulators-patients.

• Reduce duplication
• Enhance Transparency
• Save preparing time/cost
• Reduce review time
• Ensure Safety and Efficacy

The 2nd Japan-India Medical Products Regulation Symposium 2017

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 Example1
Challenge! Revision of ISO for Asian environment

• Revision of ISO22674:2006 Dentistry metallic materials

for fixed and removable restoration and appliances (JIS
T6118, 6116, 6122, 6004 etc.)
～ISO/TC106(Dentistry) SC2 prosthodontic materials/2013 International meeting Korea～
Norway Germany Canada USA Thailand Japan China etc.

〇Test methods Cf. Specified performance of EP CL /CS

2006： Linear thermal expansion (8.8) ‘btw 25 and 500℃ for each specimen’
↓
Replace 25～500 with 50～500*
Reason: Since the starting temp. is often higher than 25 in Asian country in Summer.
There is no significant difference in the calculated coefficient of the evidence data.
→25～500 or 50～500

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 Thank you very much

URL http://www.pmda.go.jp
http://www.std.pmda.go.jp/stdDB/index_e.html
The 2 Japan-India Medical Products Regulation Symposium 2017
nd

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