Government notifies medical devices rules
Arun Jaitley had announced formulating new rules for medical devices, which would help in reducing costs of devices.
New Delhi: In a move that proposes to ensure availability of drugs and diagnostics at reasonable prices, the Union health ministry on Thursday notified the Medical Devices Rules, 2016, that seek to remove regulatory bottlenecks to manufacture in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
In his Budget speech on Wednesday, finance minister Arun Jaitley had announced formulating new rules for medical devices, which would help in reducing costs of devices.
Taking note of low quality of indigenously-made medical devices, the new rules, which will come into effect from January 31, 2018, propose several measures, including third-party quality audits to regulate the device manufacturing industry.
Classified based on the severity of risk associated with a medical device, the rules have been fixed separately under these categories for instance low and low-moderate risk devices include non-invasive devices and are listed as class ‘A’ and ‘B’ devices, while moderate-high and high-risk devices, which include devices required to be inserted in the patient for long-term use, have been classified as ‘C’ and ‘D’.
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 has also been envisaged. The notified bodies, to be accredited by the National Accreditation Board for Certification Bodies (NABCB), will undertake verification and assessment of quality management system of medical device manufacturers of Class A and Class B category. “The new rules make the requirements clear for manufacturers dealing and manufacturing devices both in India and abroad. There is a clarity about registration, sale and distribution of medical devices now. This will ease the business, resulting in increased availability of equipment that will bring down out-of-pocket expenses,” K.L. Sharma, joint secretary in the health ministry, said.
The rules also seek 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 of compliance 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. “Self certification has been introduced for the first time.The criteria has been laid down for substances and some of the diagnostics and by the time we bring the law we will cover all the medical devices under its ambit,” added Mr Sharma.
Separate provisions for regulation of Clinical Investigation (clinical trials) of investigational medical devices have also been made at par with international practices. “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,” said the rules.
The new rules also for the first time lays no requirement of periodic renewal of licences. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered.