Health Regulator Seeks Private Labs for Quality Testing of Medical Devices

The health regulator agency of India is looking for private testing laboratories to test medical devices and create a mechanism of testing to ensure the quality and safety of medical devices sold in India, News18 has learnt.

Medical devices include blood pressure monitors, thermometres, glucose meters, ventilators and prosthetic limbs.

The Union government’s health regulatory agency — Central Drugs Standard Control Organisation (CDSCO) — has advised eligible private laboratories to submit applications to its office to grant licenses.

As all medical devices are now regulated under the umbrella of Medical Devices Rules (MDR), 2017, the law provides an avenue for private testing laboratories to obtain licenses as government-approved facilities for testing medical devices and issuing required test certificates.

“To strengthen the private testing facility for medical devices in the country, this office is in the process of identifying the existing private labs having the facility to test the medical devices, so that these labs may be registered under 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), called the move “a big opportunity for all existing labs”. He said that the government in a “proactive measure” has encouraged eligible private laboratories.