The Health Ministry has notified the Medical Devices Rule, 2017 in which manufacturers of medical devices will be required to meet risk proportionate regulatory requirements.
The new rules framed in conformity with Global Harmonisation Task Force (GHTF) classifies medical devices based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk), said a statement.
‘Manufacture of Class A and Class B medical devices will be licenced by State Licensing Authorities concerned after Quality Management System audit by an accredited Notified Body.’
"With a view to bring in the highest degree of professionalism in regulation of medical devices, a system of 'Third Party Conformity Assessment and Certification' through Notified Bodies is envisaged," said the statement.
According to the health ministry, the Notified Bodies will be accredited by the National Accreditation Board for Certification Bodies (NABCB).
Currently, only 15 categories of medical devices are regulated as drugs and to that extent, the current regulatory practices in India were not fully geared to meet the requirements of the medical devices sector in the country.
The new rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
"The manufacturer will, in such a case, be required to do self-certification of compliance with the requirements and based on such certification, the licence will be issued," the health ministry statement said.
"Manufacture of Class A and Class B medical devices will be licenced by State Licensing Authorities concerned after Quality Management System audit by an accredited Notified Body," said the statement, adding that for all manufacturing sites, Quality Management System will need to be aligned with ISO 13485.
"Manufacture of Class C and Class D medical devices will be regulated by the Central Licensing Authority and, where required, assistance of experts or notified bodies will be taken. Import of all medical devices will continue to be regulated by Central Drugs Standard Control Organization. A network of NABL accredited laboratories will be set up both, by the government and by other entities, for testing medical devices," said the ministry.
Conduct of clinical investigations will, while following the international practices, be conducted in a manner that ensures realisation of the twin objectives of patient safety and welfare and discovery of new medical devices.