After exhaustive stakeholder consultations, the Government of India published the new medical device and in vitro diagnostic regulations (IVD) on Jan 31, 2017. The Medical Device Rules, 2017, issued by the Ministry’s Central Drugs Standard Control Organization, will replace India’s longstanding Drugs and Cosmetics Act upon implementation. The new rules will go into effect January 1, 2018.
The term “medical device” includes any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes, reports the Economic Times.
Highlights:
- The new rules endorse a risk-based classification plan for medical devices and IVDs.
- Unique identification of medical devices and IVDs will be required by regulators, starting January 1, 2022.
- Licenses issued to device registrants will remain valid indefinitely, along with payments of license retention fees, unless cancelled or surrendered.
- The rules include fee revisions based on device classification.
- Test licenses will remain valid for three years (currently, these are valid for one-year periods).
- It is mandatory to have Notified Bodies (legal entities) conduct audits of device-manufacturing sites in India before manufacturing licenses can be issued.
- Licenses and registration certificates obtained prior to implementation of the new rules will remain valid either until expiry or after an 18-month period following implementation, whichever is later.
The Medical Device Rules 2017 in its entirety is available on request. Please use this link to get a copy.
