INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES
Voluntary Registration Phase
On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules, 2017 providing for the voluntary registration of all non-Notified medical devices over a 18-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2020 will come into full effect on April 1, 2020. The 18-month voluntary phase starts from April 1, 2020 and ends on October 1, 2021. There is likely to be a new online portal for the voluntary phase.
Mandatory Import License Phase
After the voluntary period (i.e., from October 1, 2021) all class A and B devices would have another 12 months to be registered (i.e., by October 1, 2022) in the CDSCO’s on-line portal. Class C and D devices would have another 24 months to meet the same requirement (i.e., by October 1, 2023).
The truncated 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 voluntary registration process carries no government processing fees and does not expire, but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for the mandatory Import License as per the phase and timelines mentioned in paragraph above. Once voluntary registration is completed, the local registration holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SAE) occurring in India.
As per the February 11, 2020 notifications, all medical devices will be notified and regulated in India starting April 01, 2020.
Manufacturers of currently non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for voluntary registration as per state timelines.
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.