DCGI Clarifies On Implantable Medical Device

Mumbai, 13 Nov 2019:

The Drugs Controller General of India (DCGI) has clarified on implantable medical device for its effective regulation as per new Medical Device (MD) Rules, 2017. In a notice, DCGI has defined implantable medical device as a medical device intended to be totally or partially introduced into the human or animal body or a natural orifice.

Various stakeholders of medical devices have been raising concern regarding ambiguity with respect to the definition and scope of implantable medical device, as per a DCGI notice.

As per the notice, stakeholders of medical devices have therefore been asked to refer the Fifth Schedule (Clause 3.5) of medical devices rules, 2017 which defines implantable medical device as a medical device intended to be totally or partially introduced into the human or animal body or a natural orifice. Besides this, implantable medical device is also meant to replace an epithelial surface or the surface of the eye by surgical intervention and which is intended to remain after the procedure for at least thirty days and which can only be removed by medical or surgical intervention.

It also states that all implantable devices will be regulated with effect from April 1, 2020 as per gazette notification dated February 8, 2019.

Union health ministry recently released a draft notification to notify all medical devices under the Drugs and Cosmetics (D&C) Act, 1940 to effectively regulate them as per the provisions of the said Act and new medical device rules, 2017.

As of today, 37 medical device categories have been notified.

In a notification dated February 8 this year, the Union health ministry brought all implantables along with eight new medical equipment like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under the regulatory framework.

Medical Device Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate manufacture, import, sale and distribution of the medical devices.

New MD Rules 2017 cover medical devices, invitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices.

As per the new MD Rules, 2017, state licensing authority (SLA) under the DCGI has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new rules. Class C and Class D category are audited by the Central Drugs Standard Control Organisation (CDSCO) independently as per the new rules. Pharmabiz