India to prepare detailed guidelines and procedures for testing medical devices
The government is preparing detailed guidelines and SOPs for laboratories testing medical devices. These measures are taken to strengthen the testing infrastructure for the approval of medical devices.
Currently, state regulators are randomly taking samples and conducting audits with no mandatory regulations in place on drug and pharmaceutical lines. The national medicines regulator takes the sample with its batch number and carries out the verification in its own laboratories. All states have developed laboratories so that they are able to act when needed.
A working group was set up for the exercise to map the existing laboratories available for this certification and these tests.
“A meeting was held last month on steps to strengthen testing infrastructure to enable a smoother transition to medical device licensing under the chairmanship of the Secretary of the Department of Pharmaceuticals ( DoP). A working group has been formed to prepare a roadmap to map and increase the laboratory resources required under medical device regulations. The committee must submit its report to the DoP within two months,” an official familiar with the matter said on condition of anonymity.
“There is a mandatory minimum requirement for the state regulator that each month how many such samples they must take and verify. Once the Medical Devices Regulation enters into force, testing of medical devices will become mandatory. So now this task force needs to identify which facilities within the government and which independent ones are available in the country to test medical devices,” the official said.
These labs can be NABL accredited labs, IIT labs, or National Institute of Pharmaceutical Education and Research (NIPER) labs.
In India, medical devices are a category of nearly 5,000 products. Different categories of medical devices may require different types of testing infrastructure.
“The committee will also tell us which category of product which lab may be able to test. We called on several stakeholders from the Central Drugs Standard Control Organization (CDSCO), industry, DoP, NIPER to do this exercise and give their report,” the official said.
According to CDSCO, from October 1, 2021, manufacturers of Class A & B medical devices (low-risk devices) were required to undergo a mandatory registration regime until September 2022 and device manufacturers Class C & D medical devices (high-risk medical devices) have been invited to do so until September 2023. After the mandatory registration period, these classes will respectively move to the licensing regime.
“The goal is to prepare the industry for a smooth transition regulatory regime. The tests were commissioned by the CDSCO in accordance with the standards; in addition, random samples are also in progress. This exercise will create an enabling environment and fill the existing gaps.
Mailed queries to the pharmaceutical spokesperson’s department had gone unanswered at press time.