F. No. 29/Misc/03/2020-DC (301) Part | Government of India

Directorate General of Health Services Central Drugs Standard Control Organisation (Medical Device Division) FDA Bhawan, Kotla Road New Delhi-110002

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Subject: Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer - Regarding

This is with reference to the notice published by this office vide F No 12-01-21-DC (Pt-306 —XXXVI-MDTL) dated 14.10.2021 on the subject cited above.

In accordance to above, this office is receiving the applications for registration under Medical Devices Rules 2017 from various laboratories, for testing of different medical devices and as on date more than 28 laboratories have been registered for this purpose. The list of MDTL registered by this office in published in website of CDSCO (www.cdsco.gov.in)

In order to enhance the testing capacity of medical device in the country identification registration & empanelment of government private testing laboratory for medical devices testing is under consideration as per MDR 2017.

In this regard, laboratories which have capacity for testing of medical device & are NABL accredited are requested to submit the application in Form MD-39 along with requisite fees and documents, through online portal www.cdscomdonline.gov.in., for taking further necessary action in the matter. sl

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• (Dr V. G. Somani)

• To: Drugs Controller General (I) 4. All Stakeholders through CDSCO website 2. All |lTs (Delhi, Mumbai, Chennai, Kharagpur, Hyderabad, Guwahati etc). 3. All IISC (Bangalore, Pune, Bhopal, Thiruvananthapuram etc) 4. Director, DRDO. DRDO Bhawan, Rajaji Marg, New Delhi-110011 5. Director CSIR, Anusandhan Bhawan, 2 Rafi Anmed Kidwai Marg, New Delhi - 110001

• 6. Director NIPER, Sector 67, S.A.S. Nagar - 160062, Punjab (INDIA). 7. Director, NIPER Sila Katamur (Halugurisuk), P.O.: Changsari, Dist: Kamrup, Assam, Pin: 781101, Assam, India
• 8. Director NIPER, Opposite Air force Station, Palaj, Gandhinagar-382355, Gujarat, India. .

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Copy to

1. PS to JS(R), MoHFW, Nirman Bhawan, New Delhi.