Drugs Controller General of India, DCGI, is notified that all implantable devices are treated as Drugs in the country. All the rules and regulations liable on the drugs are applicable on all implantable devices and other medical devices.
Dr. VG Somani, DCGI, is informed that all implantable devices and various medical devices like CT Scan equipment, MRI equipment, Defibrillators, PET equipments, Dialysis machines, Xray machines and Bone marrow cell separator are also regulated as drugs from April 1st 2021.
The importers and manufacturers are required to take import manufacturing licence from Central Licencing Authority or Stale Licencing Authority for import manufacture of above devices, with effect from 01.04.2021.
In the meantime, representations have been received, requesting to extend implementation of this notification for another 3 to 6 months because a lot of procedural work is to be done such as resolution of queries, audit of facilities by the regulators and notified bodies, testing of products at the requisite testing labs etc.
As per the notification, it may be pertinent to mention that Rule 97 of Medical Device Rules (MDR) 2017 provides details about applicability of the said rules in respect of various actions operations undertaken under Drugs & Cosmetics Rules for the substances and devices referred to in rule 2 of the MDR 2017 prior to commencement of MDR 2017.
Central Government has been decided that in case an existing importer or manufacturer who is already importing /manufacturing any of these devices, has submitted application to Central Licencing Authority or State Licencing Authority, for grant or import manufacturing licence in respect of above mentioned devices under the provisions of MDR, 2017 can continue to import and manufacture the said devices up to 6 months from issue of this order or till the time.
