Cdsco Clarifies The Definition Of Implantable Medical Device After Stakeholders Raise Concerns

By Author: Clini Experts
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Summary: The Medical Device Regulation India
doesn’t cover the manufacture and sale of certain medical devices. Clarifying the definition of implantable medical devices will regulate the market better and will also refine the drug license application process and import of drugs in India
.

In a notification published on 8 Feb. 2019, the central government announced that all implantable medical devices along with several other medical equipment will be considered a drug under the Drugs and Cosmetics Act 1940.

However, the definition of ‘implantable medical devices’ was not very clear among the manufacturers of such devices. Hence in response to the queries of the stakeholders, CDSCO released a new notification in November 2019, clearly stating the definition of such devices.

According to CDSCO, an implantable medical device is a :

● “Medical devices intended to be totally or partially introduced into the ...
... human or animal body or a natural orifice.
Or
● Device 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.”

This definition has been specified in the fifth schedule (clause 3.5) of the Medical Device Rules, 2017. Moreover, all medical implantable devices will be regulated under this act as drugs w.e.f 1st of April, 2020.

What are its implications?

The medical device market is highly unregulated in India. Since the Indian markets are emerging, and trying to keep pace with the global markets. The drafting and implementation of sturdy regulations in the medical industry is quite faltering.

Since implantable medical devices are an extremely delicate and risky addition to a living body, they have to be strictly regulated for quality. This new enforcement will ensure that the implantable medical devices are better regulated and more safe for the use of Indian citizens.

This decision has brought all implantable medical devices along with some other diagnostic devices under the strict regulation of CDSCO. This step will also help improve the credibility of the Indian implantable medical device manufacturers, since most such devices being used today are imported.

Another benefit to the Indian manufacturers and users will be the substantial reduction in price of such devices. Since implantable devices are mostly imported, they tend to be highly priced.