Draft of National Policy for Medical Devices 2022 Issued and Feedback Invited till March 25

The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has released an approach paper for the Draft National Policy for the Medical Devices, 2022.

It has invited feedback and remarks of the industry and stakeholders on it till March 25, 2022.

The sector is expected to grow in market size from the present USD 11 Bn to USD 50 Bn by 2025.

The medical device is a multi-product sector, with the following broad classifications: (a) Electronics Equipment; (b) Implants; (c) Consumables and Disposables; (d) IVD reagents; and (e) Surgical Instruments.

The Indian medical devices sector’s contribution has become even more prominent as India supported the global battle against COVID-19 pandemic through the production of medical devices & diagnostic kits, eg, Ventilators, RT-PCR kits, IR Thermometers, PPE Kits & N-95 masks.

The proposed policy strives to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector and addressing the further challenges of the sector such as regulatory streamlining, skilling of human resources and lack of technology for high end equipment and lack of appropriate infrastructure, through a coherent policy framework.