Comprehensive Medical Device Regulations Coming to India

The Indian Central Drugs Standard Control Organization (CDSCO) took another step closer to implementing comprehensive medical device regulations. On October 18th, a draft of the ‘Medical Device Rules, 2016’ was formally published for public comment. These Rules are similar to those informally circulated in July to industry stakeholders. A link to the document is available here on the Asia Actual website (the English version starts on page 145).

Key elements to the draft Rules are:

  • New risk based classification system (A, B, C and D) for medical and IVD devices
  • Requirement for all Class B, C and D devices to be registered (Class A will be voluntary)
  • Licenses already issued under the current Rules will remain valid either for a further 18 months or until license expiry, whichever is later.
  • Devices newly requiring registration that make application within 180 days of the implementation date of the Rules can be continuously imported until a new license is issued or rejected (with proof of importation prior to implementation date)
  • Increase of government processing fees to US$3,000 per Plant Master File and US$1,500 per Device Master File (Class C or D as an example)
    Licenses to remain valid indefinitely (with payment of retention fee every 5 years)
  • Technical data requirements are very similar to current requirements

The Implementation date is hard to predict, but expected by Q2 of 2017 with some changes between the draft and final versions of the document likely.

Manufacturers are advised to evaluate the impact of the new Rules on their sales strategy in India and consider early preparation of new registration applications. Long application processing times are anticipated when the new Rules are implemented. For perspective, there are currently about 14,700 Class B, C and D medical and IVD devices registered in Singapore compared to around 700 active Registration Certificates in India.

More details and guidance are expected in the coming weeks.

Contact Asia Actual to register medical devices in India under the new comprehensive medical device regulations.