**Policy Summary: Strengthening Private Medical Device Testing Laboratories in India**
The Central Drugs Standard Control Organization (CDSCO), the National Regulatory Authority under the Ministry of Health and Family Welfare, is undertaking measures to strengthen private medical device testing facilities in India. This initiative stems from the implementation of S.O. 648E and G.S.R. No. 102 E, both dated February 11, 2020, which brought all medical devices under the Drugs and Cosmetics Act, 1940, and the Medical Device Rules (MDR), 2017.
Currently, some private testing laboratories are registered under MDR, 2017, to conduct testing and examination of specific medical devices on behalf of manufacturers. To augment these capabilities, CDSCO is identifying existing private laboratories equipped to perform necessary medical device testing, encompassing physical, chemical, microbiological, mechanical, and electrical tests, for potential registration under MDR, 2017.
The communication, dated April 2, 2024, from the Directorate General of Health Services, requests organizations with relevant testing facilities to identify their capabilities and submit an application in Form MD39, along with required information and fees as specified in MDR, 2017, to become registered medical device testing laboratories. The responsible officer for this policy is Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India.
Key Entities Referenced
Central Drugs Standard Control Organization: National Regulatory Authority in India responsible for medical devices regulation.
Medical Device Rules, 2017: Rules governing the regulation of medical devices in India.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India, under which CDSCO operates.
Drugs and Cosmetics Act, 1940: The principal law governing drugs and cosmetics in India, now including medical devices.
Form MD39: Application form for registration of medical device testing laboratories as per MDR, 2017.
Dr. Rajeev Singh Raghuvanshi: Drugs Controller General of India.
S.O. 648E dated 11.02.2020: Notification related to the regulation of medical devices under the Drugs and Cosmetics Act.
G.S.R. No. 102 E dated 11.02.2020: Notification related to the regulation of medical devices under the Drugs and Cosmetics Act.
DFA/2487
File No.:MED/2/2024-eoffice
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Medical Device Division)
FDA Bhawan, Kotla Road,
New Delhi - 110002,
Dated: | D anny
a
To,
All stakeholders through CDSCO website.
Subject: Strengthening of private Medical Devices Testing Laboratory in the
country - Reg.
You may be aware that CDSCO is the National Regulatory
Authority under Ministry of Health and Family Welfare responsible for
ensuring the quality, safety and performance of medical devices under
Medical Device Rules, 2017.
In consequent to implementation of S.O. 648(E) dated 11.02.2020
and G.S.R. No. 102 (E) dated 11.02.2020, all the medical devices have
come under Drugs and Cosmetics Act, 1940 and Medical Device Rules,
2017.
Presently, certain private testing labs have been registered under
MDR, 2017 for testing & examination of certain medical devices in the
country on behalf of the manufacturer. In order to strengthen the private
testing facility for medical devices in the country, this office is in the
process of identifying the existing private labs having the facility to test
the medical devices, so that these labs may be registered under MDR,
2017. It is observed that your organization is having testing facility for
carrying out various tests of medical devices. The medical devices
require various tests including Physical, chemical, microbiology,
mechanical & electrical etc.,
In view of above, it is requested that you may kindly identify your
facility for testing of the above tests for medical devices and submit the
application in Form MD-39 along with the requisite information with fees
as per MDR, 2017 for registration of testing laboratory behalf of the
manufacturer.
This is for your information and necessary action in the matter.
=
(Dr. Rajeev Singh Raghuvanshi)
Drugs Controller General of India.
File No. MED/2/2024-eoffice (Computer No. 4185)
Generated from eOffice by RAJEEV SINGH RAGHUVANSHI, DCI-RSR-CDSCO, DCG(I), CDSCO-HQ on 02/04/2024 06:05 PM