The ministry of Health and Family Welfare has decided to extend the date of implementation of the unique device identification (UDI) of medical devices, which was was to come into effect from 1 January 2022, till further orders. Under Rule 46 of the Medical Device Rules, the government had earlier decided, “With effect from 1st day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identifier and production identifier.” This order was earlier notified via the Gazette of India GSR78 (E), dated 31.01.2017.
There are several clarifications expected in the coming year, while there was extensive work by the regulators in the past year including listing of devices and attempts to bring in some price regulation. Industry sources says that new dates for the implementation of unique device identification (UDI) will also affect the regulations on packaging and identification or track and trace is likely to be spelled out in the coming year. The UDI would also affect the important area of smart medical devices that are connected to the Internet and which increasingly play a role in healthcare productivity and areas such as remote monitoring and telemedicine.
There is a regulatory update in the form of a yearly wrap for 2021 for medical devices in India by Varsha Rajesh, Tanya Kukade, Darren Punnen & Dr. Milind Antani. It is available on the website of Nishit Desai and Associates, a research and strategy driven international firm with offices in Mumbai, Palo Alto, Bangalore, Singapore, New Delhi, Munich, and New York. The firm is an active participant in shaping India’s regulatory environment, and has the expertise and foresight to navigate the complexities of regulation and compliance in India.
Annual update on medical devices
Other updates discuss the major developments in the medical devices industry and the changes in licensing requirements in 2021. It discusses three orders issued by the Central Drugs and Standard Control Organization (CDSCO) – India’s apex drug regulator. It states, “Through the Medical Device Compliance Order, the CDSCO initially relaxed the manufacturing and import license requirements for nebulizers, blood pressure monitoring devices, digital thermometers and glucometers. Subsequently, a similar relaxation was introduced for the manufacturers/ importers of implantable devices, CT scan equipment, MRI equipment, defibrillators, PET equipment, dialysis machine, X-ray machine, and bone marrow cell separator (“Notified Devices”). The Medical Devices Compliance Orders state that existing manufacturers/importers of the Notified Devices may continue their manufacture/import activities up to June 30, 2022 provided they have already made an application for the relevant license to the CDSCO before April 18, 2021.”
The Medical Device Rules, 2017 (MDR) only applies to medical devices specifically notified by the Ministry of Health and Family Welfare as regulated medical devices. “Once a device is regulated under the MDR, persons engaged in the manufacture, import and sale of medical devices are required to obtain a license from the relevant drug regulatory authorities to undertake such activities pertaining to the notified medical devices.”
The Medical Devices Compliance Order says that that manufacturers and importers who have already been dealing in the regulated devices may continue to do so as long a license has been applied for even if it may not have been granted as yet. The applications for license will be deemed as valid licenses till 30 June 2022 or until a decision is made. The entire document is available on the website of Nishith Desai Associates at https://www.nishithdesai.com/NewsDetails/20.
