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Centre ties up with 50 private laboratories to test medical devices

As many as 50 private laboratories have joined hands with the Central government to test medical devices for quality, safety and efficacy.

Currently, there are only six Central government labs that are allowed to test certain devices, which are unable to meet growing demand.

A sunrise sector
The medical devices sector in India is a sunrise sector with the market size estimated to be $11 billion in 2020. Its share in the global medical device market is estimated to be 1.5%.

“Creating of a new lab is time-consuming and requires a lot of manpower. And one of the concerns for medical devices is that we cannot draw the samples like drugs and send it to the labs for testing. Medical devices require various tests including physical, medical, microbiology, chemical & electrical etc. to ensure the quality,” said an official requesting anonymity.

“We do have a few private testing labs that have been registered on behalf of manufacturers under the Medical Devices Rules, 2017, for testing and examination of certain medical devices. However, the requirement is more.

Therefore, we have registered at least 50 private labs for testing of medical devices wherein manufacturer can send the product for testing whether it is maintaining the quality standard or not and accordingly the regulator can review the testing report,” said the official.

“These labs are being strengthened at par with government labs so that the scope of testing of medical devices can be increased. For example, if a lab is testing 10 types of medical devices, we are upgrading these labs so that more devices can be tested,” the official said.

Medical devices comprise electronic equipment; implants; consumables and disposables; surgical instruments and in-vitro diagnostic reagents among others. Testing at government labs is free of cost. However, private labs will charge for it.

Recently, the Centre also directed state government to designate their state labs as government labs for testing certain medical devices.

India is 80% dependent on imported medical devices. However, the government is working to reduce this by building medical device parks and clusters.

Queries sent to the health ministry spokesperson remained unanswered till press time. LiveMint

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