The well being regulator company of India is on the lookout for non-public testing laboratories to check medical gadgets and create a mechanism of testing to make sure the standard and security of medical gadgets bought in India, News18 has learnt.

Medical gadgets embrace blood stress displays, thermometres, glucose meters, ventilators and prosthetic limbs.

The Union authorities’s well being regulatory company — Central Drugs Standard Control Organisation (CDSCO) — has suggested eligible non-public laboratories to submit functions to its workplace to grant licenses.

As all medical gadgets at the moment are regulated beneath the umbrella of Medical Devices Rules (MDR), 2017, the regulation gives an avenue for personal testing laboratories to acquire licenses as government-approved amenities for testing medical gadgets and issuing required check certificates.

“To strengthen the non-public testing facility for medical gadgets within the nation, this workplace is within the means of figuring out the prevailing non-public labs having the ability to check the medical gadgets, in order that these labs could also be registered beneath Medical Devices Rules (MDR), 2017,” said the notice issued by the drug regulator of India, who heads CDSCO.

The notice, issued on April 3, highlighted that medical devices require multiple tests, including physical, chemical, microbiological, mechanical and electrical.

The regulator has requested laboratories to identify if their facility can run these tests for medical devices and submit the application for registration of testing laboratory on behalf of the manufacturer.

Move overdue but needed more discussions: Experts

Experts say the move was overdue but needs a coordinated consultation approach between several authorities and departments.

Rajiv Nath, managing director, Hindustan Syringes & Medical Devices (HMD), hailed the move while adding that more discussions are required for a successful implementation.

Nath, who is also the forum coordinator of Association of Indian Medical Device Industry (AIMED) said they have been pushing the Union government for the same for over two years. “The move requires a coordinated consultation approach between Bureau of Indian Standards (BIS), Quality Council of India (QCI), National Accreditation Board for Testing and Calibration Laboratories and Indian Institutes of Technology (IITs), existing reputed private laboratories, government labs and manufacturers.”

Dr PV Appaji, former director-general, the Pharmaceutical Export Promotion Council of India (Pharmexcil), referred to as the transfer “a giant alternative for all present labs”. He said that the government in a “proactive measure” has inspired eligible non-public laboratories.