New Rules Medical Devices India
New Rules Medical Devices India

REGULATORY

REGULATORY

New Rules Medical Devices India

TRANSITION FROM DRUGS TO MEDICAL DEVICES

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.

ADMIRUS

AS A REGULATORY PARTNER
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100%

Highly Trained Regulatory Team
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90%

Deep Understanding of US, EU & SE Asian Markets
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100%

Expertise in the New Medical Device Rules
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100%

Direct Lines of Communication with Indian FDA
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100%

Located at Delhi, seat of all action
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100%

Shortest Processing time in Industry

IMPORT

OF MEDICAL DEVICE

Application for Import of Medical Devices or In Vitro Diagnostic Kits (Any Class A/B/C/D)

Apply on MD 14 and obtain approval on MD 15

IMPORT

OF MEDICAL DEVICE

Application for Import of Medical Devices or In Vitro Diagnostic Kits (Any Class A/B/C/D)

Apply on MD 14 and obtain approval on MD 15
Medical Device Registration in India

APPROVAL

For Medical Devices Manufactured in India

Application for Sale or Distribution of Class A or B Medical Devices or IVD Kit

Medical Device Registration in India
New Rules Medical Devices India

CLINICAL TRIALS

& Investigation

CLINICAL TRIALS

& Investigation
New Rules Medical Devices India

MANUFACTURE

Or Import of Medical Devices Without Predicate Device
New Rules Medical Devices India

ENGAGE WITH US