BioSpectrum India Magazine November issue BioSpectrum India Magazine - Page 24

24 COVERStory BioSpectrum 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 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 HIGHLIGHTS OF INDIAN MEDICAL DEVICES MARKET  The Indian medical device market has grown from $2.0 billion (Rs 13,130 crore) in 2009 to $3.9 billion (Rs 25,269 crore) in 2015 at a CAGR of 15.8%  The Indian medical device market contributes to 4% of the Indian healthcare market which is pegged at $96.7 billion (Rs 6.29 crore) in 2015  The medical device market in India can be segregated into seven distinct categories.  Diagnostic imaging is the largest segment within Indian medical device market at $1.18 billion (Rs 7650 crore) in 2015.  The other categories comprising of patient monitors, ECG machines, Defibillators, etc. was estimated at $0.94 billion (Rs 5,922 crore) in 2015  Similarly the IV diagnostics market constituted of $0.39 billion (Rs 2550 crore) in 2015  Orthopedics and Prosthetics and Consumables were pegged at $0.90 billion (Rs 5,850 crore) in 2015  Dental Products and Patient Aids were pegged at $0.47 billion (Rs 2,961 crore) in 2015  The import of medical devices has grown from $2.46 billion (Rs 15,990 crore) in FY 12 to $2.87 billion ( Rs 18,665 crore) in FY 16  The export of medical devices has grown from $0.78 billion (Rs 5,070 crore) in FY 12 to $0.98 billion (Rs 6,370 crore) in FY 16  The total import of medical devices is more than 75 per cent of total medical devices sales in India. However, it is estimated that import trade will fall with increasing number of international and Indian manufacturer setting up medical device manufacturing units in India. Source: Andhra Pradesh Medtech Zone Ltd (AMTZ) | November 2017 | 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 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