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2026.02.18 S.O. 912(E)_Notification of Medical Device Testing Officers (MDTO) for Laboratories


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Importer & Manufacturer   |   Source: CDSCO
Published On: 18-02-2026

Enforcement Date: 18 April, 2026
2026.02.18 S.O. 912(E)_Notification of Medical Device Testing Officers (MDTO) for Laboratories

The Ministry of Health and Family Welfare (MoHFW) has issued a notification designating Government Analysts as Medical Device Testing Officers under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017. The notification assigns specific medical device categories to government testing laboratories across India to strengthen regulatory oversight and quality assurance.


The Ministry of Health and Family Welfare has issued a notification dated 18 February 2026 designating Government Analysts as Medical Device Testing Officers under the Drugs and Cosmetics Act 1940 and the Medical Devices Rules 2017.


This notification supersedes the earlier notification issued on 10 December 2024, without affecting actions taken prior to its replacement. The notification assigns Medical Device Testing Officers across central and regional government laboratories to ensure quality testing and regulatory compliance of medical devices.


The designated laboratories include facilities located in Kolkata, Chennai, Mumbai, Guwahati, Chandigarh, and the National Institute of Biologicals in Noida. The officers are authorized to test a wide range of medical devices, including


  1. Sterile and single use medical devices
  2. Non sterile medical devices
  3. Surgical dressings and medical gloves
  4. Mechanical contraceptives and disinfectants
  5. In vitro diagnostic medical devices
  6. Biochemical kits molecular diagnostic kits and blood grouping reagents


This step strengthens regulatory oversight and supports effective implementation of medical device quality and safety standards in India.

Applicable For: Importer & Manufacturer
Reference Number: CG-DL-E-20022026-270381 Notification Link

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