While the Budget 2017 saw the finance minister announcing the formulation of medical device rules, simultaneously the Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices. Only 15 categories of medical devices are, at present, regulated as drugs and to that extent, the current regulatory practices in India were not fully geared to meet the requirements of 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.
Here are the major amendments
Classification of Medical Devices
(1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in the following classes, namely:—
- low risk – Class A;
- low moderate risk- Class B;
- moderate high risk- Class C;
- high risk- Class D.
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.
Third Party Conformity Assessment and Certification
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. 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.
To evolve a culture of self-compliance by manufacturers of medical devices and, accordingly,
- The manufacturing licences for Class A medical devices will be granted without prior audit of manufacturing site. The manufacturer will, in such a case, be required to do self-certification ofcompliance with the requirements and based on such certification, the licence will be issued. However, post approval audit of manufacturing site will be carried out by the Notified Bodies to check conformance with Quality Management System.
- Manufacture of Class A and ClassB medical devices will be licenced by State Licensing Authorities concerned after Quality Management System audit by an accredited Notified Body. 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 CDSCO. A network of NABL accredited laboratories will be set up both, by the Government and by other entities, for testing medical devices.
Regulation of Clinical Trials
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. Conduct of clinical investigations will, while following the international practices, be conducted in a manner that ensures realization of the twin objectives of patient safety and welfare and discovery of new medical devices. Medical management and compensation will be provided to the subjects of clinical investigation in accordance with the predefined and objective criteria laid down by the Government.
No requirement of periodic renewal of licences
There will be no requirement of periodic renewal of licences. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered. Further, the entire process starting from submission of application to grant of permission/licence will be processed through online electronic platform. Timelines have been defined for most activities at the regulators end. The issuance of licences for Class A medical devices on the basis of self-certification coupled with a system of checks and balances for ensuring compliance is a departure from the inspection based regulatory regime. Risk based audit of manufacturing units will be carried out to assess conformance with standards and quality parameters. These Rules envisage creation of a robust eco-system for all stakeholders including innovators, manufacturers, providers, consumers, buyers and regulators.
Read the full Gazette notification of India below