Our Emerging market series continues! In previous Emerging markets articles, we looked in detail at some of the largest medical device markets, specifically Asia Pacific, Middle East, and Latin America and further analysed a selection of the markets in each region.

Now, we’re looking into those territories once again to offer a more succinct look at some of the other potential access markets in those regions, starting with India.

The Indian medical devices market: a growing opportunity

The market size of the medical devices industry in India is expected to grow at a rate ahead of the current industry average. India is also one of the fastest growing medical device markets amongst the current emerging markets and the fourth largest in the Asia Pacific region.

Medical devices in India are regulated by the Central Drug Control Organization (CDSCO), headed by the Drug Controller General of India (DCGI). In the past few years, the regulatory system for medical devices greatly matured due to the introduction of new Regulatory Device Rules in 2017. With the most recent medical device Rules Act of 2020 they have since tightened up their requirements to bring themselves in line with the more mature regulatory markets like the EU. Foreign manufacturers will require proof of regulatory approval from an accepted reference agency (including USA, Canada, EU, UK Australia, and Japan).

Foreign manufacturers with no local presence in India must appoint an authorised representative in the Indian market to manage and advise on registration filings and dealing with submissions via the online application portal (SUGAM) and post market requirements.

Medical device and risk classes

For most device risk classes (Class B to D and Class A Measuring or sterile) technical documentation must be submitted for review in the form of a Device Master File (DMF).

Class A – Non-Measuring/Sterile Devices are now exempt from import license requirements: a relatively recent Class I exemption ruling simplifies access for some low-risk class I devices.

A notification act issued in late 2022 formalised the exemption of Class A non-measuring and non-sterile medical devices making them exempt from the Import License process, meaning products of those classifications do not need to submit Device Master File or Plant Master File. This can save a significant amount of time and money on technical documentation and service fees if the companies devices qualify. However, there are still some registration and self-certification activities which need to be carried out, involving the uploading of basic device and manufacturer information.

For all other Class devices, the Device Master File and Plant Master File are required. The Device Master File is not unlike a STED format technical file document which many manufacturers may already have prepared for UK or EU Market access.  The Plant Master File is required for each manufacturing site and includes evidence of ISO 13485 certification, manufacturing processes, plans and site operation details. On successful review and approval site and device license will be issued.

Final things to consider before entering the Indian medical device market:

• There are different pathways dependent on whether you can identify a similar (predicate) device. Product which are novel or do not have a similar device will require additional review and requirements, this can still be reduced if the device has received approval in a recognised market (UK, US, Australia, Canada, Japan) for more than 2 years.
• A distributor can be used as your authorised agent; however, this is generally advised to use a dedicated representative service, this ensures you have full control of your registration certificates.

For more detailed information on the requirements for accessing India with your product contact us at hello@imedconsultancy.com