Experts share their views and insights on the impact and implications on this move by MoH&FW
We appreciate the Indian government’s decision to regulate all medical devices
AdvaMed and its member companies appreciate Indian government’s decision to regulate all medical devices under the guidelines issued by the Ministry of Health as per the Medical Devices Rules 2017 and strengthen regulations to improve safety and quality of products available in India. We believe this decision to make norms more stringent and the Ministry of Health’s investment in capacity building by recruitment of specialised auditors will benefit the medical devices industry and the patients at large. We congratulate MoH&FW for its efforts to support Prime Minister Narendra Modi’s ‘Make in India’ initiative by globally harmonising India’s regulatory structure, which will enable domestic manufacturers of medical devices and IVDs to make in India for the world. It will prove pivotal in enabling a more predictable pathway for globally recognised technology to enter India and lessen the gap between India’s access to research-based medical devices and diagnostics.
The move will ensure that all medical devices available will be safe and effective
CII Medical Technology Division welcomes this move, as this will ensure that all medical devices available will be safe and effective. The temporary registration application for devices that are currently unregulated will require basic administrative documents and product information. The registration process carries no government processing fees and does not expire till the manufacturer/importer obtain the import/manufacturing licence within a period of 36 and 42 months for class A,B and C,D devices respectively. The temporary registration may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by an Import/ Manufacturing License. Once registered, the local registration holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.