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Centre asks states to establish laboratories for evaluating medical devices

The union health ministry has directed state governments to set up their own laboratories for testing and evaluation of medical devices amid a push for medical device manufacturing.

Medical devices include products such as electronics equipment, implants, consumables and disposables, IVD reagents and surgical Instruments.

The government has also specified that all medical device testing laboratories should be accredited to the National Accreditation Body for Testing and Calibration Laboratories (NABL).

This will help create an enabling environment and fill the existing gaps in the backdrop of India importing 80% of its medical device requirements, especially from China.

“The State Government may, by notification, establish State Medical Devices Testing Laboratory for the purpose of, — (a) testing and evaluation of medical devices; or (b) to carry out any other function as may be specifically assigned to it,” read a government notification seen by Mint.

Furthermore, the state government may designate any laboratory having the facility for carrying out testing and evaluation of medical devices as State Medical Devices Testing Laboratory for the purposes, it said.

Queries sent to the health ministry spokespeople went unanswered.

In India, medical devices are a category of almost 5,000 products. Different categories of medical devices may require different kinds of testing infrastructure.

The testing of medical devices is being done as per Central Drug Standard Control Organisation (CDSCO) norms notified in the medical devices rules, 2017.

In 2021, CDSCO directed all manufacturers of category A & B medical devices (low risk devices) to come under a compulsory registration scheme and manufacturers of category C & D medical devices (high risk medical devices) were directed to do so up to September 2023. After the compulsory registration period, these classes will respectively move to the licensing regime.

This seeks to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety. LiveMint

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