Predicate Device Identification in India

Identifying a Predicate Device in India

In addition to risk classification and grouping, the cost and time required to register a medical device in India is also influenced by the existence of a registered predicate device on the market.

If a medical device is seen by the regulators as having a predicate device registered in India, then a standard Form MD-14 (Import License) application process is followed.  However, if a medical device is considered as not having a predicate device registered in India, then pre-market, or post-market clinical data from India may be a required element of the registration application as determined on a case-by-case basis by Subject Expert Committee (SEC) review.

Definition of Predicate Device in India

The definition of a “predicate device” in India as per the Medical Device Rules, 2017 is as under:

Section 3, Definitions:

(zm) “predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for license in India;”

Predicates as Part of the Registration Process

As of October 1, 2021, all medical devices will need to be at least Registered with the CDSCO while specific product categories, called Notified Devices, will need to obtain an Import License prior to importation. Registrations of Non-Notified devices do not currently require the identification of predicate devices to register. However, since all Class A and B devices will become Notified on October 1, 2022 and October 1, 2023 for Class C and D, all manufacturers will need to identify a predicate as part of maintaining market access in the future. In addition to identifying a predicate, the CDSCO will also want to see that the product has been approved in the country of origin, also known as Home Country Approval.

Technically, all first applications for each product category of non-Notified devices will not have a registered predicate on the market (as registration was not required).  This situation as the potential to require many clinical studies being done in India.  To alleviate some of the burden, devices that have been registered in a reference market (the US, Europe, the United Kingdom, Japan, Canada, or Australia) for more then 2 years, will be exempted from the local clinical data requirement.

How to Identify a Predicate Device in India

In order to identify a predicate device in a country, the manufacturer will first need to identify similar products. These products will need to use similar technology and have the same indications for use. For example, a drug eluting coronary stent cannot use an ordinary coronary stent since the product doesn’t use a drug. Furthermore, for a drug eluting stent to use another as a predicate, it would also need to use the same drug in similar quantities.

One of the best ways to identify similar products is to identify competing products, especially those that are at larger companies or have been around a while. This will increase the likelihood of these products being registered internationally and in more markets. If manufacturers can compare their products to the same product in each market, it can significantly reduce the overall regulatory burden. Then, once the manufacturer has a list of potential predicate devices, they will need to confirm that these products are registered in India. To do so, the manufacturers can work with a local partner to conduct this research, search the CDSCO’s public database, or use Asia Actual’s Registration Optimized Search Engine (R.O.S.E.) which aggregates registered products from public databases throughout Asia. At the time of publishing, India’s registrations are not searchable in R.O.S.E. but will be by October 1 when all Class A and B devices will need to identify a predicate as part of the Import License process.