India is projected to take over China as the most populist nation very soon. The economy is also following the same direction of growth, where the economy is estimated to touch the $3.5 trillion USD by March 2023, and is projected to double by 2030 to $7 Trillion USD. At the time of writing this article, the Indian medical device market is estimated to be at $12 Billion USD, making it the 4th largest Asian medical device market, after Japan, China and South Korea. The Indian medical device market is expected to grow at a compound annual growth rate (CAGR) of 15%, which is 2.5 percent the global rate. India is commonly thought of as one of the best places to sell medical devices due to the simple fact that they import a large quantity of them each year, 70-80 percent import dependency from countries such as the US, China, and Germany to be exact. As one can imagine, exposure to this market could be a very lucrative opportunity for manufacturers.
The regulatory framework of India does fair some similarities with the EU. The Central Drugs Standard Control Organisation (CDSCO), headquartered in New Delhi, is India’s national regulatory body for cosmetics, pharmaceuticals, and medical devices. The CDSCO serves similar purposes to the European Medicines Agency of the European Union, the FDA of the United States and the MHRA of the UK. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
The CDSCO establishes safety, efficacy, and quality standards for pharmaceuticals and medical devices. It publishes and updates the Indian Pharmacopeia, a list of regulated pharmaceuticals and devices. For all drug and device applications, the CDSCO appoints notified bodies to perform conformity assessment procedures, including testing, to ensure compliance with their standards. The CDSCO is also divided into several zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when necessary.
Within the CDSCO, the Drug Controller General of India (DCGI) is responsible for the regulation of pharmaceuticals and medical devices. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
The Licensing and classification of medical devices are handled by the CLAA (Central Licensing Approval Authority). Among other responsibilities, the CLAA also enforces safety standards, appoints notified bodies to oversee conformity assessments, conduct post market-surveillance and issue warnings and recalls for adverse events.
Contrasting from the EU, India has one regulation which encompasses both medical devices and In-Vitro diagnostic devices. The document is entitled the Medical Device Rules published by the Ministry of Health and Family Welfare, abbreviated to MDR (try not to confuse this with the EU MDR). The document can be accessed using the link below.
| Europe | India |
| MDR | Medical Device Rules |
| IVDR |
Similar to the MDR and IVDR, the Medical Device Rules of the CDSCO lay out the requirements that need to be met in order to market your device in India, including classifications of devices and technical documentations requirements.
Like the MDR and IVDR, there are a total of four classes of medical devices which vary in risk. The devices are classified using an alphabetical code (similar to the IVDR) from A corresponding to a low-risk device to D corresponding to a high-risk device. This can be seen in the table below.
| Risk | Device Class India | Device Class EU | ||
| Type of Device | Medical Device | In-Vitro Diagnostic Device | Medical Device | In-Vitro Diagnostic Device |
| Low Risk | A | A | I | A |
| Low-Moderate Risk | B | B | IIa | B |
| Moderate-High Risk | C | C | IIb | C |
| High Risk | D | D | III | D |
In order to regulate all the medical devices placed on the Indian Market, the Ministry of Health and Family Welfare in India has published G.S.R. 102(E) dt 11.02.20 with effect from 1st of October 2022. The notification states that Class A (Measuring and Sterile) and all Class B devices must have an Import License by the date mentioned above to maintain market access. There is also mention of a 6-month grace period for Registered Class A and Class B devices that have submitted an Import License application prior to 30th of September 2022.
While the low-risk medical devices under class A which are non-sterile and non-measurable do not require an import license, they still need registration as self-certified products with CDSCO.
These MDR rules are applicable for all the Manufacturers based in India and also applicable for Importers of medical device in India.
Should you wish to gain exposure to this market, we have a very knowledgeable contact based in Mumbai. Deven Chandegra heads a consultancy firm providing Regulatory support services needed to achieve CDSCO License (Indian MDR). Among other services, he also works for Non-Indian Manufacturers to get CDSCO License with their Indian clients.
If you would like an introduction to Deven Chandegra to discuss the opportunity of entering the Indian market, please do let us know!
