Medical Devices in India had been governed by the Drugs and Cosmetic Act, 1940 and were treated as “drugs” as such for all matters pertaining to regulatory compliances. In 2018, the Ministry of Health of the Govt of India, brought into force new legislation in the form of the New Medical Rules 2017 to correct the long-standing anomaly, and bring all medical devices under a defined framework under which these would be governed henceforth. While the Rules have introduced a risk-based classification system for licenses and approvals that are in keeping with global regulatory standards, domestic and international Manufacturers and Importers would still need assistance from experienced players who can hand-hold them in obtaining the necessary regulatory approvals for product registration and import licenses in accordance with the new requirements listed in the New Medical Device Rules.
Admirus is a natural choice for such Clients seeking regulatory consultancy. With its decade old experience, highly trained staff and one hundred per-cent record of on-time and successful delivery of Projects, organisations like the UKTI, US Commercial Service, Canadian Trade Commission, Israel Trade & Economic Office, Flanders and KOTRA routinely refer their Manufacturers to Admirus for their Indian FDA-related queries.