Last week the Indian government officially published the Medical Devices Rules, 2017 providing for the comprehensive regulation of all medical and IVD devices in India. The Rules will come into full effect on January 1, 2018. A link to the document is available here on the Asia Actual website (the English version starts on page 143).
Key elements to the Rules are:
1. New risk based classification system (A, B, C and D) for medical and IVD devices
2. Import License requirement for all Class A, B, C and D devices going forward; initial application will be for devices requiring registration under the former Rules with new devices categories added in a rolling basis
3. Licenses already issued under the old Rules will remain valid until June 30, 2018, or license expiry whichever is later.
4. Application processing fees charged by the government will be:
Classification Type Plant Master File Device Master File
Class A Medical Device US$1,000 US$50
Class B Medical Device US$2,000 US$1,000
Class C Medical Device US$3,000 US$1,500
Class D Medical Device US$3,000 US$1,500
Class A IVD Device US$1,000 US$10
Class B IVD Device US$1,000 US$10
Class C IVD Device US$3,000 US$500
Class D IVD Device US$3,000 US$500
5. Import Licenses do not expire with payment of a retention fee every 5 years
6. Retention fees are the same as new application fees
7. Technical data requirements are very similar to those under the current Rules
Foreign manufacturers are advised to evaluate how the new regulations apply to their product portfolio and consider early preparation of new registration applications.
Asia Actual is available for consultations and will announce guidelines as they are available.