The Government of India notified in February 2017 the new Medical Device Rules 2017, which will come into force starting January 1, 2018. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices. Following this, there have been several additional regulatory updates set out by the Government 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.
As a start, the Medical Device Rule 2017 will likely pertain only to devices that are currently regulated by the Central Drugs Standard Control Organization CDSCO). No new device types except those updated “from time to time” will fall under Medical Device Rules requirements. This may clear up a major question as to the scope of the new regulations and which types of devices would fall under new Indian registration requirements. Besides, device registrations obtained under the existing Indian registration system will remain valid until 2020; foreign manufacturers may still register under the current system through January 1, 2018.
Furthermore, the Union health ministry has issued, in June 2017, the draft list of medical devices and in vitro diagnostics along with their risk-based classifications. 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). There has also been a clarification on the devices which fall under the definition of drug, a list of 15 devices which can be accessed here.
On another note, in the latest step by Prime Minister Narendra Modi's government to make drugs and medical devices more affordable, there have been new device additions to the National List of Essential Medicines (NLEM). The widely used cobalt chromium knee cap implants’ price has been capped at Rs. 54,720 ($852) (previously priced at up to Rs. 250,000 ($3,895)). Before this there have been speculations that around four critical devices, apart from cardiac stents, which is already under price control, are likely to be brought under the NLEM.
This follows the recent announcement at the Indian Parliament to make it mandatory for all medical devices to carry maximum retail price (MRP) on packages from January 1, 2018. Every package must bear name, address, telephone no, e-mail of persons, office in case of complaints.