New Delhi: The Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on January 31, 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.
Medical devices will, under the new rules, be classified as per GHTF practice, based on 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.
With a view to bring in the highest degree of professionalism in the 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.
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. Manufacture of Class A and Class B medical devices will be licenced by State Licensing Authorities concerned after Quality Management System audit by anaccredited 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.
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.
The new rules have many other unique features. It will be for the first time that 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
The rules will provide a conducive environment for fostering India specific innovation and improving accessibility and affordability of medical devices across the globe by leveraging comparative cost advantage of manufacturing in India. The objective, transparent and predictable regulatory framework will boost the confidence of investors and, as a consequence, the quality and range of products and services will improve and business burdens will be reduced. The new rules will help in developing a quality standardization framework in India at par withinternational standards. The implementation of these rules will provide the assurance of the best quality, safety and performance of medical devices. These rules coupled with other measures, taken by the Government in the recent past, are expected to sharpen the competitive edge and provide incentives to firms to become more efficient, innovative, and competitive. All this will support entrepreneurship, market entry and economic growth that, in turn, would produce high-paying, high-quality jobs.
Not the one we had expected, says industry
“We are delighted with release of the latest medical devices regulations as separate rule book different from pharmaceutical and though it has provision of third party certification but are still highly disappointed that the government has lost the opportunity to use these as a Make in India enabler and ease of doing business by unbundling regulations to achieve Maximum Governance and Minimal Government,” said Mr Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) adding, “The proposed regulations may result in closure of domestic manufacturing and drive jobs out of India as more Mfr of high-risk high technology devices will switch to imports!”
“Let’s hope the government addresses this in the medical devices bill and walks the entire mile – it is discrimination if Indian Manufacturers of high-risk devices can’t have market access till they prove compliance to rules after factory inspection but this requirement of factory’s inspection is not mandatory for overseas plants,”added Mr Nath.
The Medical Technology Association of India in its reaction hoped that the implementation of final bill will include its recommendations. “Since the implementation of these rules is yet a year away, and because the Health Ministry and CDSCO has kept all stakeholders closely engaged, we are hopeful that any adjustments, which may be in overall patient interest and assured availability of these devices, can still be made,” the association said, “The rules have clear guidelines on clinical trials for medical devices as well as imports, including a provision to ‘inspect overseas manufacturing site.”
However, Mr Simranjit Singh, General Manager, Medical Devices & Diagnostics, Asia, QuintilesIMS called the move a potential one to bring about breakthrough changes. “The decision to delink Medical Devices from Pharmaceuticals is a much needed and welcome step,” he said adding “The rules provide for a higher level of scrutiny and rigor that will have a long term positive impact on the safety and use of Medical Devices, in addition to creating a transparent, predictable and safer regulatory regime that will catalyze the entire sector. It is important to note that regulators have taken cognizance of stakeholder feedback to the draft rules in developing the Medical Devices Rules 2017, while not compromising patient safety. Such a collaborative approach by the regulators is appreciated and is a much needed step in a relatively greenfield area.”