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Regulation Information:

Regulation of Medical Devices

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  • MoHFW has published a notification vide G.S.R 78(E) dated 31.01.2017 the medical device rules 2017 implemented w.e.f. 1.1.2018 vide.

  • MoHFW has published a notification vide S.O. 648 (E) dated 11.02.2020 to notify all devices.

  • MoHFW has published a notification vide G.S.R 102 (E) dated 11.02.2020 regarding the registration of certain medical devices in a phase-wise manner for voluntary registration followed by registration and licensing.

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Registration of non-notified medical devices

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  • The MOHFW has also amended MDR-2017 vide G.S.R 102(E) dated 11.02.2020, regarding the registration of all non notified medical devices which is effective from 01.04 2020 as under-

  • The Medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation

  • The applicant’s registration number will be generated by CDSCO. The manufacturer/ Importer shall mention the registration number on the label of the medical device.

  • Registration shall be on a compulsory basis for Class A & B MDs up to September 2022 and Class C & D up to September 2023 there after it shall be mandatory for a license.

Useful information on MDs

Activity
Class A
Class B
Class C
Class D
QMS verification by
*Notified body
*Notified body
CLA
CLA
Sale
SLA
SLA
SLA
SLA
Permission to conduct CI
Permission from CLA
Permission from CLA
Permission from CLA
Permission from CLA
Manufacture
SLA
SLA
CLA
CLA
Import
CLA
CLA
CLA
CLA

Existing devices

Applicant
Risk/Class
Type of license
Forms
Importer
A,B,C,D
Import license
Application: MD-14 Permission: MD-15
Manufacture
A,B
Manufacturing license
Application: MD-3 Permission: MD-5
Manufacture
A,B
Loan license
Application: MD-7 Permission: MD-9
C,D
Manufacturing license
Application: MD-8 Permission: MD-10
Loan license
Application: MD-4 Permission: MD-6

New devices

Applicant
Risk/Class
Types of License
Forms
Manufacturer
A, B, C & D
Test License
Application: MD-16 Permission: MD- 17
Manufacturer
A, B, C & D
Manufacturing License
Application: MD-26 Permission: MD- 27
Manufacturer
A, B, C & D
Clinical Investigation Permission
Application: MD-22 Permission: MD- 23
Importer
A, B, C & D
Test License
Application: MD-16 Permission: MD- 17
Importer
A,B,C & D
Import Licence
Application: MD-26 Permission: MD- 27
Importer
A,B,C & D
Clinical Investigation Permission
Application: MD-22 Permission: MD- 23

Some useful information

Import or manufacture a medical device which does not have its predicate device  

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The clinical investigation may not be required to be submitted where the regulatory authorities approve the investigational medical device of either the United Kingdom or the United States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that country and If the Central Licensing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.

RISK BASED CLASSIFICATION

Medical devices are notified by the Central Government and classified by the CLA based on the classification rules specified in the First Schedule of the MDR 2017.

Following are the risk Classes and the classification criteria based on the severity of risk associated with the medical device.

Risk Criteria
Risk Class
High
Class D
Moderate-High
Class C
Low-Moderate
Class B
Low
Class A

RISK BASED CLASSIFICATION

  • Manufacture of Class A and Class B are regulated by the State Licensing Authority concerned and notified bodies will carry out Quality Management System audit.

  • Manufacture of Class C and Class D are regulated by the Central Licensing Authority and where required assistance of experts or notified bodies will be taken;

  • Import of all medical devices are regulated by the Central Licensing Authority.

  • Notified Bodies are accredited by NABCB. Thereafter, be registered with the CLA to assist the SLAs in verification and assessment of Quality Management System of Medical Device Manufacturers of Class A and Class B devices.

  • Standards of medical Devices in MDR,2017: The medical device shall conform to the standards laid down by BIS (Bureau of Indian Standards) or may be notified by Central Government from time to time. If, such standards are not available then ISO, IEC or any other pharmacopeial standard. If all are not available then device shall conform to the validated manufacturers standard.

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