Medical Device Regulations
Medical Device Regulations
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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.
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
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.
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
Activity
IMPORT CLA CLA CLA CLA
Permission to
conduct
CLINICAL Permission from CLA
INVESTIGATIO
N
SALE SLA
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Medical Devices which do not have a predicate device will
undergo through a clinical investigation to establish safety
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Class A devices exempted from clinical
investigation.
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History of medical device regulations in Japan
– recent big amendments (1/2)
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
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History of medical device regulations in Japan
– recent big amendments (2/2)
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
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- 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
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Scope of regulations on medical device/IVD
marketing in Japan under PMD Act
Manufactur
Registration as a Manufacturer
ing facility
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Medical Device Regulations in Japan
Example
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COMPANY/ MANUFACTURING FACILITY
REGULATION
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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)
Since 2014
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Example of manufacturing site registration
Release
to the market
Registration
Required Not Required Not Required Required Not Required Required
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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
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QMS Inspection Authority
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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
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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
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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
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Review Time of Brand-new Medical
Devices
Priority items
(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)
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Registration and Supervision of certification
body
Registration
MHLW 2. Ask for assessment
5. Registration
PMDA
of Certification
Body 4. Report assessment result
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
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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
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Number of approvals of Medical Devices
Band-new MDs 18 33 46 94 67
Breakdown
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Recent measures taken related to medical
device regulations in Japan
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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
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Establishment of new international regulatory
harmonization strategies by MHLW and PMDA
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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.
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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.
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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.
* 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.
Flow from Design & Safety trials Clinical trials Application Approval
development development Performance trials
to approval
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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.
3D laminated structure technology using orthopedic Pharmaceutical and Food Safety Bureau
implants Council 0912 No. 2, issued on Sep. 12, 2014.
Risk
+
Benefit
Speed of Solid
patient access evidence
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<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
1
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
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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
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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.
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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
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PMDA Organization
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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
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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
8
How we control the quality of certification body
Registration
2. Ask for assessment
MHLW
5. Registration of PMDA
Certification Body
4. Report assessment result
10
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
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
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Certification Standards (Class II)
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Certification Standards (Class II)
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Certification Standards (Class II)
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Certification Standards (Class II)
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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
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Framework of Standards in Japanese regulation
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Process for Certification Standards, etc..
② Secretariat
Industrial PMDA
Association Office of Standards MHLW
WG in Industrial Association
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.
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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
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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
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List of Certification Standards
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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.
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Summary
• Reduce duplication
• Enhance Transparency
• Save preparing time/cost
• Reduce review time
• Ensure Safety and Efficacy
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Example1
Challenge! Revision of ISO for Asian environment
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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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