Strengthening Private Medical Device Testing Facilities in India

The Central Drugs Standard Control Organization (CDSCO) is seeking to strengthen the country’s private medical device testing facilities. CDSCO has issued a public notice issued inviting applications from existing private labs to register for testing specific medical devices. This public notice was issued on April 3, 2024.

The notification highlights the importance of ensuring the quality, safety, and performance of medical devices. In light of the Medical Device Rules, 2017, all medical devices in India must undergo mandatory testing and examination. Presently, a limited number of private labs are registered to conduct these tests.

CDSCO’s Call to Action
  • The CDSCO is inviting applications from private labs that have the facilities to perform various medical device tests.
  • These tests include physical, chemical, microbiological, mechanical, and electrical examinations.
Benefits of Increased Testing Capacity
  • A larger pool of registered testing labs can help expedite the testing process for medical devices.
  • This can lead to faster product approvals and market availability of new medical technologies.
  • Ultimately, it can contribute to improved patient care by ensuring access to safe and reliable medical devices.
How to Apply

Hence, the notice specifies that interested private labs can submit applications in Form MD-39, along with the requisite fees, for registration with the CDSCO.

Therefore, by expanding the availability of reliable testing facilities, CDSCO seeks to streamline the approval process and promote advancements in medical technology.