Testing Labs for Medical Devices - Latest News
The Health Ministry issued a final notification revising the MDR, 2017. It has introduced new sub-rules that define the establishment of state medical device testing laboratories. Operon Strategist stays on top of all the recent medical device industry updates. Subscribe to our Newsletter for all the updates.
The medical device sector is expected to grow from 11 billion US dollars to 50 billion US dollars by the end of 2025. With this significant development for the healthcare industry, the Union Ministry of Health and Family Welfare (MoHFW) has issued a final notification amending the Medical Devices Rules (MDR), 2017, which promotes the establishment of state medical device testing laboratories across the nation.
As the medical device sector experiences a regulatory shift, this amendment plays a vital role in the licensing regime to ensure the quality, safety, and efficacy of medical devices.
The Indian medical device industry was unregulated until 2017. To control and regulate medical devices the MoHFW framed the MDR, 2017 under the Drugs and Cosmetic Act of 1940. To take it further, the government of India revised the MDR, 2017. With the licensing regime already in place for some medical devices since 2022 and further regulations set to come into effect in October this year, the demand for testing operations is expected to rise.
The recent amendments to the Medical Device Act enabling the establishment of National Medical Device Testing Laboratories are a positive step towards improving the regulatory framework in India.
With more and more amendments, it’s difficult to understand norms and regulations, and they’re becoming more stringent day by day.
Operon Strategist, with its comprehensive range of expertise and services, is dedicated to helping manufacturers comply with regulations. We offer comprehensive medical device turnkey project services to help manufacturers at national as well as international levels.
