Medical Device Regulation in India

Bidya Dhar Sahu

 Medical Devices regulation in India

o Earlier, 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).

o Now, the quality, safety and efficacy of notified medical devices manufactured,
imported and sold in the country are regulated under the Medical Device Rules,
2017.
 The Govt. of India has notified…
S. No Name of the device Earlier to Jan Date of notification
2018 MD that were not
SLA/CLAA notified, but included
1 Disposable Hypodermic Syringes SLA 17-03-1989
in the Schedule:
2 Disposable Hypodermic Needles SLA 17-03-1989
• Sutures and Ligatures
3 Disposable Perfusion Sets SLA 17-03-1989
4 In vitro Diagnostic Devices for HIV, HbsAg and HCV and SLA 27-08-2002 • Disinfectants
blood grouping sera

5 Cardiac Stents CLAA 06-10-2005 • Blood Grouping Sera

6 Drug Eluting Stents CLAA 06-10-2005
• Surgical Dressing
7 Catheters CLAA 06-10-2005
8 Intra Ocular Lenses CLAA 06-10-2005 • Umbilical Tapes
9 I.V. Cannulae CLAA 06-10-2005
10 Bone Cements CLAA 06-10-2005
• Condoms
11 Heart Valves CLAA 06-10-2005
• Intra Uterine Devices
12 Scalp Vein Set CLAA 06-10-2005
13 Orthopedic Implants CLAA 06-10-2005 • Vaginal Tubal Rings
14 Internal Prosthetic Replacements CLAA 06-10-2005
15 Ablation Devices *CLAA 25-01-2016
3
 Medical Devices Rules, 2017 in India
§ 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.

§ The Rules was effect from 1st day of January, 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.

§ Apex regulatory body in India, Central Drugs Standard Control Organization (CDSCO),
M/o HFW, Govt. of India.
 Scope of the regulation
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);
 Medical Devices Rules, 2017 in India
There are 12 chapters:
Chapter- I Preliminary, Title, Application, Commencement, Definition
Chapter - II Regulation of Medical Devices, Classification of MD, Grouping of MD, Essentials Principles
Chapter - III Authorities, delegation of powers, Notified bodies, Medical Devices Testing Centres,
Chapter - IV Manufacture of Medical Devices-Application, Inspection, grant of license, conditions of license,
Suspension, Cancellation, Appeal, Test License
Chapter - V Import of Medical Devices-Application, Overseas Inspection, grant of lic, Test lic, Hospital use, Personal
use
Chapter - VI Labelling requirement for Medical Devices
Chapter - VII Clinical Investigation of Medical Device and Clinical Performance Evaluation of New In Vitro Diagnostic
Medical Device (Permission, Medical management, Compensation, Inspection)
Chapter - VIII Permission to import or manufacture medical device which does not have predicate medical device

Chapter -IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer and Notified Body

Chapter -X Registration of Laboratory for Carrying out Test or Evaluation

Chapter - XI Sale of Medical Devices
Chapter - XII Miscellaneous – Rejection of application, Export of MD, Debarment of applicant, Exemptions
 Medical Devices Rules, 2017 in India
There are 08 Schedules:
Schedule Number Title
First Parameters for classification of medical devices and in vitro diagnostic medical devices
Part I: Parameters for classification of medical devices
Part II: Parameters for classification for in vitro diagnostic medical devices
Second Fee payable for licence, permission and registration certificate
Third Documents required for registration of Notified Body, its duties and functions.
Part I: Documents to be furnished along with application in Form MD-1 for grant of certificate of
registration
Part II: Duties and functions of Notified Body
Fourth Documents required for grant of licence to manufacture for sale or for distribution or import
Part I: Power of Attorney
Part II: (i) Documents to be submitted with the application for grant of Import Licence or licence to
manufacture for sale or for distribution of a Class A medical device
Part III:
Appendix I (Contents of a site or plant master file)
Appendix II (Device Master File For Medical Devices Other Than In Vitro Diagnostic Medical Devices)
Appendix III (Device Master File For In Vitro Diagnostic Medical Devices)
Part IV: Information required to be submitted with the Application Form for import or manufacture of
medical devices which does not have predicate device
 Medical Devices Rules, 2017 in India

There are 08 Schedules:

Schedule Number Title

Fifth Quality Management System (QMS) for medical devices and in vitro diagnostic medical devices

Sixth Post Approval Change - Major and Minor Changes

Seventh Requirements for permission to import or manufacture investigational medical device for
conducting 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
 Risk based classification……...…….
• 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 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
 Scheme of Medical Device regulation
Device Class Class A Class B Class C Class D

Activity

IMPORT Import Licence Import Licence Import Licence Import Licence

*Manufacturing Manufacturing Manufacturing License Manufacturing

MANUFACTURE
License (SLA) License (SLA) (CLA) License (CLA)

CLINICAL For an Investigational medical device, the applicant shall need to obtain Permission from
INVESTIGATION CLA to conduct clinical investigation of Class B, Class C and Class D
FOR investigational And
DEVICES and new IVDs Clinical Performance Evaluation of new IVDs

SALE Regulation as per Current D & C Rules

*Notified Bodies Notified Body CLA CLA
QMS Verification by

* Licence will be issued without prior inspection...

 Regulatory Authorities
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
INVESTIGATION

SALE SLA

QMS Verification *Notified *Notified Body CLA CLA

by Body

*Note: Notified Bodies shall be registered with Central Licencing Authority (CLA). Prior
inspection shall not be required before the grant of manufacturing of Class A
devices. [SLA: State Licensing Authority]
 Regulatory Authorities

• Application for Import, manufacture, Clinical Investigation/Performance

evaluation of new IVD/MD of Class C and Class D, 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 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.
 Technical Requirements : for the applications
Regulatory Compliance Class A Class B Class C Class D

QMS Compliance (manufacture) P P P P

Electrical Safety/EMI/EMC testing
*P *P *P
data
Risk Analysis Report P P P
Device Master File P P P
Biocompatibility data **P **P **P
Animal Testing (if required) ***P ***P ***P
Clinical Investigation P P
* Only for Electrical supply based devices
**Only for invasive or implantable devices
***Only for Investigational devices
 Manufacture of Medical Device for Sale or Distribution

Class A and B

Ø Manufacturer shall apply through an identified online portal of Ministry with requisite
documents as per Fourth schedule and fees specified in Second schedule.
Ø No audit for class A device prior to grant of license.
Ø The audit may be carried out within 120 days from the date of issue of license.
Ø The audit for Class B device is necessary prior to the grant of manufacturing license
and the audit shall be carried out within 90 days from the date of application.
Ø The notified body shall furnish its report to SLA within 30 days.
 Manufacture of Medical Device for Sale or Distribution

Class C and D

Ø The application shall be made with requisite documents and fees through online
portal of the Central Government to CLA.
Ø CLA may use the services of any expert and of a notified body and may carry out an
inspection within a period of 60 days from the date of application.
Ø No inspection of a medical device manufacturing site for grant of loan license to be
carried out if the site is already licensed to manufacture such devices.
Ø After completion of inspection, the inspection team shall forward the report to CLA
through online portal.
 Scope of 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 Notified Body.
 Registration & Regulation of Notified Bodies

vRegistered with CDSCO.

vAccredited by National Accredited Body (such as National
Accreditation Board for Certification Bodies (NABCB)).

vProcedures prescribed in schedules for registration of

notified bodies.
vSchedule of fee to be charged by notified bodies.
vDuties, functions and obligations of notified bodies specified
in the Third Schedule of the rules.
 Technical Requirements for the applications
• 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.
 Major policies of the Rules

• 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.

• Provisions for loan licence.

• For Regulators- Establishment or designation of Govt. laboratories for testing.

• For Manufacturers- Testing laboratories registered under these rules.

 Standards of medical devices

i. BIS (Bureau of Indian Standard) 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.

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 Clinical investigation
• 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)

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 Medical Devices Testing Laboratory

• The Central Government by notification may establish Central medical devices testing laboratory for
the purpose of,—
(a) testing and evaluation of medical devices; or
(b) functioning as an appellate laboratory; or
(c) to carry out any other function as may be specifically assigned to it.

• “medical devices testing laboratory” will be registered under sub-rule (3) of rule 83 for carrying out
testing or evaluation of any medical device on behalf of a licencee for manufacture for sale;
• Medical Devices Testing Laboratories will be responsible for carrying out performance evaluation for
IVDs and medical devices testing.
• Medical Devices Regulatory must have accreditation from NABL and shall follow GLP practices.
 Exempted Medical Devices

• 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.

• Devices intended for charity – exempted from import licence

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 Forms related Medical Devices
Form MD-1: Application for grant of Certificate of Registration of a Notified Body
Form MD-2: Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017
Form MD-3: Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or
Class B medical device
Form MD-4: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class
A or Class B medical device.
Form MD-5: Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.

Form MD-6: Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical
device
Form MD-7: Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or
Class D
 Forms related Medical Devices
Form MD-8: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of
Class C or Class D
Form MD-9: Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form MD-10: Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical
device
Form MD-11: Form in which the Audit or Inspection Book shall be maintained.
Form MD-12: Application for licence to manufacture medical device for purpose of clinical
investigations, test, evaluation, examination, demonstration or training
Form MD-13: Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or
Test or Evaluation or Demonstration or Training
Form MD-14: Application for issue of import licence to import medical device
Form MD-15: Licence to Import Medical Device
Form MD-16: Application for Licence to Import Medical Devices for the Purposes of Clinical
Investigations or Test or Evaluation or Demonstration or Training
 Forms related Medical Devices
Form MD-17: Licence to Import Medical Devices for the Purposes of Clinical Investigations or
Test or Evaluation or Demonstration or Training
Form MD-18: Application for licence to import investigational medical devices for the purposes
by a government hospital or statutory medical institution for the treatment of patients
Form MD-19: Licence to import investigational medical device by a government hospital or statutory
medical institution for the treatment of patients
Form MD-20: Application for permission to import small quantity of medical devices for personal use
Form MD-21: Permission to import of small quantity of medical devices for personal use
Form MD-22: Application for Grant of permission to conduct clinical investigation of an investigational
medical device
Form MD-23: Permission to conduct Clinical Investigation
Form MD-24: Application for grant of permission to conduct clinical performance evaluation of new in vitro
diagnostic medical device
 Forms related Medical Devices
Form MD-25: Permission to conduct clinical performance evaluation of new in vitro diagnostic
medical device
Form MD-26: Application for grant of permission to import / manufacture for sale or for
distribution of medical device which does not have predicate medical device
Form MD-27: Permission to import or manufacture for sale or for distribution of medical device
which does not have predicate medical device
Form MD-28: Application for grant of permission to Import or Manufacture for sale or for
distribution of new in vitro diagnostic medical device
Form MD-29: Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
Form MD-30: Memorandum to the Central Medical Device Testing Laboratory
Form MD-31: Certificate of test or evaluation by the Central Medical Device Testing Laboratory
Form MD-32: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
Form MD-33: Application from a purchaser for test or evaluation of a Medical Device under section 26
of the Drugs and Cosmetics Act, 1940 (23 of 1940)
 Forms related Medical Devices
Form MD-34: Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940,
(23 of 1940) requiring a person not to dispose of stock in his possession
Form MD-35: Receipt for stock of medical devices for record, register, document or material object seized
under clause (c) or clause (cc) of sub-section (1) of Section 22 of the Drugs and Cosmetics
Act (23 of 1940)
Form MD-36: Intimation of Person from Whom Sample is taken
Form MD-37: Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-
section (1) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused
Form MD-38: Memorandum to Medical Device Testing Officer
Form MD-39: Application for grant of registration to Medical Device Testing Laboratory for carry out Test or
Evaluation of a medical device on behalf of manufacturer
Form MD-40: Certificate of registration to Medical Device Testing Laboratory for carry out Test or
Evaluation of a medical device on behalf of manufacturer
Medical Device Clusters in India

Visakhapatnam,
Andhra Pradesh
 Materiovigilance Programme is initiated under PvPI

q National Coordination Centre (IPC, Ghaziabad).

q National Collaboration Centre ( Sree Chitra Tirunal Institute of Medical

Sciences and Technology, Tiruvananthapuram).

q Technical Support and Research Centre (National Health System Resource

Centre- NHSRC).