On November 1st, the Drug Controller General India released a Notice detailing risk-based classification of 351 medical devices and 247 IVD devices that require registration under the new Medical Device Rules 2017 going into effect on January 1, 2018.
Most of the devices are regulated currently, however, several devices are arbitrarily clubbed under existing notified device categories. Examples include (1) infusion pumps, (2) orthodontic guide wire (3) endoscopic forceps, (4) transcervical/transabdominal endoscopes, etc. Additionally, the device category Ablation Devices, as listed on line number 3 of the list, now includes RF generators.
This new list is similar to the draft floated on August 22, but excludes the following devices:
- Inflation device
- Pacing lead
- Enteral pump
- Collection bag
- Orthodontic bands/bracket
- Glaucoma drainage stent
- Trabeculotomy probe
All other medical devices will be added to the scope of new Rules in phases over the coming months by Ministry of Health and Family Welfare gazette notifications.
Device manufacturers are advised to conduct a careful review of the list (full document available at the bottom of the India page of the Asia Actual website) to confirm near term regulatory requirements for products marketed in India.
Asia Actual is available to assist with device registration and independent license holding service. Please contact us with any questions or support requests.