**Summary:**
A notice from the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), New Drugs Division, Government of India, announces a review of the regulatory regime for drug approval. As per the Medical Devices Rules, 2017, this review includes strategies to enhance the testing capacity of medical devices within the country, specifically focusing on the identification, registration, and empanelment of both government and private testing laboratories. Laboratories possessing the capacity for medical device testing and interested in participating in this process are requested to communicate their interest to CDSCO via email at mdcdsco.ni@gov.in. This communication should include comprehensive details regarding the medical devices they are equipped to test, along with a clear articulation of their testing capabilities.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the approval of drugs, medical devices, and other related products.
New Drugs Division: A division within the Central Drugs Standard Control Organization (CDSCO) responsible for the regulation of new drugs.
FDA Bhavan, Kotla Road, New Delhi: The location of the Central Drugs Standard Control Organization (CDSCO) headquarters.
Medical Devices Rules, 2017: The regulatory framework governing medical devices in India.
CDSCO: An abbreviation for Central Drugs Standard Control Organization
Directorate General of Health Services: An attached office of the Department of Health and Family Welfare, Ministry of Health & Family Welfare.
medical devices: Medical Devices which are regulated by CDSCO
F. No. 12-01/21-DC (Pt-306 — XXXVI- MDTL)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(New Drugs Division)
FDA Bhavan, Kotla Road,
Neaw Deelhi ‘U 4 OCT am
Notice
‘Subject: Review of regulatory regime for drug approval — Reg
Le ercier to enienos te testing capacity of medical devices in the country identification
stration & empanelment of government private testing laboratories for medical
device testing is under consideration as per medical devices Rules, 2017.
1is regards, laboratories which have capacity for testing of medical devices & are
x it 0 rere in above process are requested to intimate the same to
uch med die c . acd esco.ni¢ re
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devices: and capacities & capabilities: of testing to CDSCO for