On October 18th, 2019 the Ministry of Health and Family Welfare published a draft of the Medical Device Rules, 2019 as a proposed amendment to the Medical Device Rules, 2017 requiring the registration of all non-Notified medical devices over a 42-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2019 will come into full effect after being approved and published in the official gazette. The draft notification allows 30 days from 18 October 2019 for public comment and stakeholder feedback.

The plan calls for an 18-month voluntary registration period after which all class A and B devices would have 16 months to be registered (i.e., by Sep 17, 2022) in the CDSCO’s on-line portal. Class C and D devices would have 24 months to meet the same requirement (i.e., by May 17, 2023).

The registration application involves administrative documents such a Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The registration process carries no government processing fees and do not expire, but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for an Import License (upon Notification). Once registered the local license holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.

Further, the registration process will generate a registration number which the importer must mention on the label of the medical device prior to placing the devices on the market (i.e., after Customs clearance).

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact Asia Actual to arrange an initial conversation.