The Ministry of Health and Family Welfare has finalised Medical Devices Rules, 2017. The new rules have been framed in conformity with Global Harmonisation Task Force (GHTF). The new rules will remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
Under the new rules, Medical Devices will be classified as per GHTF practice based associated risks into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.
A system of ‘Third Party Conformity Assessment and Certification' through Notified Bodies is envisaged which is in view to bring in the highest degree of professionalism in regulation of medical devices. The Notified Bodies will be accredited by the National Accreditation Board for Certification Bodies (NABCB). The NABCB will, before accrediting Notified Bodies, assess their competence in terms of required human resources and other requirements. These Bodies will undertake verification and assessment of Quality Management System of Medical Device Manufacturers of Class A and Class B category and may, on as required basis, be called upon to render assistance for regulation of Class C and D medical devices also.
Under the rules, 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. 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 CDSCO. A network of NABL accredited laboratories will be set up both, by the Government and by other entities, for testing medical devices.
Separate provisions for regulation of Clinical Investigation (clinical trials) of investigational medical devices (i.e. new devices) have also been made at par with international practices and, like clinical trials, these will be regulated by CDSCO.