The Central Drugs Standard Control Organisation (CDSCO) has released a draft list to revise the current risk-based medical device classification in India for neurological and cardiovascular medical devices. The CDSCO has invited industry stakeholders to respond to the draft by April 30, 2025. The draft includes 553 medical devices, including 351 cardiovascular devices and 202 neurological devices. In total, 221 of the 553 products are Class D devices, 153 are Class B devices, 151 are Class C devices, and 28 are Class A devices. Currently, medical devices in India are organized into 24 distinct categories and designated a risk class, with class A being the lowest risk and class D being the highest risk. The new draft appears consistent with the Medical Devices Rules (MDR) 2017 and the International Medical Device Regulators Forum (IMDRF).
In addition, the CDSCO has released a fully digitized workflow for the issuance of Market Standing Certificates (MSC) and Non- Conviction Certificates (NCC). Notably, stakeholders will have to resubmit their applications through the upgraded online portal, effective April 9, 2025. The digital transformation comes as part of CDSCO’s larger initiative aimed at improving transparency and efficiency in the medical device regulatory pathway. Typically, any applications submitted under the old system will be canceled automatically, and only new submissions via the new system will be accepted. The implementation of these programs only applies to manufacturers and importers holding valid CDSCO medical device licenses. The MSC serves to determine a company’s regulatory status, and the NCC indicates that the company has not been previously convicted in relation to the quality and safety of its medical devices.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.