The government is formulating detailed guidelines and SOPs for laboratories to test medical devices. These measures are being taken to strengthen the testing infrastructure for licensing of medical devices.
As of now, state regulators conduct samples and verification without any mandatory rules on the lines of drugs and pharmaceuticals. The state drug regulator selects the sample with its batch number and conducts verification in its laboratories. All the states have developed laboratories so that they can take action when needed.
A task force has been constituted to map the existing laboratories available for such certification and testing.
A meeting was held last month under the chairmanship of Secretary, Department of Pharmaceuticals (DOP) on measures to be taken towards strengthening testing infrastructure to enable easy transition to licensing for medical devices. A task force has been constituted to prepare a road map for mapping and augmentation of laboratory resources required under the Medical Devices Regulations. The committee will have to submit its report to the postal department within two months.
“There is a minimum mandatory requirement for the state regulator as to how many such samples they have to take and verify every month. After the implementation of the Medical Devices Regulation, testing of medical devices will become mandatory. So now, this task force is to identify the government and independent facilities available in the country for testing of 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 about 5,000 products. Different categories of medical devices may require different types of testing infrastructure.
“The committee will also tell us which category of products which labs may be able to test. We have brought in several stakeholders from Central Drugs Standard Control Organization (CDSCO), Industry, DoP, NIPER to undertake this exercise and report it,” the official said.
According to CDSCO, with effect from October 1, 2021, manufacturers of category A and B medical devices (low risk devices) will be allowed to come under the compulsory registration scheme by September 2022 and manufacturers of category C and D medical devices (high risk devices). was told. medical devices) was directed to do so by September 2023. After the mandatory registration period, these classes will progressively move to the licensing regime.
“The aim is to prepare the industry for a smooth transition regulatory regime. Testing as per norms has been made mandatory by CDSCO; Apart from this, random samples are also being taken. This exercise will create an enabling environment and fill in the existing gaps.
Queries sent to the Department of Pharmaceuticals spokesperson at press time remained unanswered.