**Summary:**
On February 27, 2018, the Central Drugs Standard Control Organization (CDSCO), Government of India, issued a directive (Ref. No. IVDMisc030DCG118) to all State/UT Drugs Controllers regarding the recognition of medical device testing laboratories. This directive addresses concerns raised before the implementation of the Medical Device Rules, 2017, specifically related to In Vitro Diagnostic Medical Device testing. It pertains to laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) under ISO 15189:2012, as per Section 28 of the Drugs and Cosmetics Act, 1940 and Rule 71 of the Medical Device Rules, 2017, prior to January 31, 2018.
The directive outlines that NABL-accredited laboratories can continue testing, calibration, and validation of medical devices. Furthermore, the Central Government may designate a Government Analyst from State/UT laboratories accredited by NABL under Section 20, Rule 18 of the Act. It also proposes designating Medical Device Testing Officers, with the appropriate qualifications and experience in relevant testing, within accredited laboratories.
Dr. S. Eswara Reddy, Drugs Controller General of India, is the contact person for this directive. Copies of the directive have been circulated to all Zonal and Sub Zonal Offices of CDSCO for review and coordination with State Licensing Authorities (SLAs).
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
FDA Bhawan, Kotla Road, New Delhi-110002: Address of the Central Drugs Standard Control Organization (CDSCO) headquarters.
State/UTs Drugs Controller: Drug regulatory authorities in various States and Union Territories of India.
Medical Device Testing Labs: Laboratories involved in testing medical devices, related to accreditation and designation as Government Analyst.
Medical Device Rules, 2017: The regulatory framework governing medical devices in India.
Drugs and Cosmetics Act, 1940: The primary legislation governing drugs and cosmetics in India, which is relevant for the accreditation of testing laboratories.
National Accreditation Board for Testing and Calibration Laboratories: Organization responsible for accrediting testing and calibration laboratories in India.
Dr. S Eswara Reddy: Drugs Controller General of India
F. No, IVD/Misc/030/DCG1/18
Government of India
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road,
New Delhi-110002
To
Dated: 27 FE 8 2018
All State/UT’s Drugs Controller,
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(Dr. S Eswara Reddy)
Drugs Controller General (India)
Copy to:
All Zonal and Sub Zonal Offices of CDSCO for, peruse the matter with the concerned SLAs.