In a recent notice by the CDSCO, new licensing requirements have been introduced for Class C and Class D medical devices for all importers/manufacturers across India effective from the 1st of October 2023. This regulatory update will not only aid in the smooth progress of the supply of medical devices but also ease the challenges faced by importers/manufacturers in licensing procedures.
India has one of the largest medical devices industries in the world. In order to regulate this booming industry, the Medical Device Rule 2017 (MDR 2017) was established on 1st January 2018 for the purpose of regulatory requirements for medical device companies. These regulations are overseen by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare in India. The CDSCO acts as the National Regulatory Authority of India (NRA).
With effect from the 1st of October 2023, the CDSCO has announced that it will implement complete licensing requirements for Class C and Class D Non- notified medical devices. The CDSCO has notified all importers/manufacturers to apply for the licenses (along with the required documents) before the October deadline so as to avoid any disruption in the flow of medical devices in India.
This regulatory update is extremely important as this marks the final step in transitioning all medical devices to the new rules. The CDSCO is currently alerting all importers/manufacturers to the said deadline to avoid them getting affected, as there were no licensing requirements previously. Failure to do so may lead to heavy penalties in the medical devices market.
According to the new update issued by the CDSCO –
Importers/manufacturers failing to register for their respective licensesand non-compliance with the said legislation will lead to strict penal action against them, as established under the Drugs and Cosmetics Act, 1940.
The licensing of medical devices across India has a huge impact on the industry and market dynamics as well,
The Central Licensing Authority of India or CDSCO grants the medical device manufacturing license. The following table provides an insight into the different forms for the licensing procedure
Form | Purpose |
MD-7 | Application of Manufacturing License |
MD-8 | Application of Loan License |
MD-9 | Grant of Manufacturing License |
MD-10 | Grant of Loan License |
From the 1st of October 2023, Class C and Class D non-notified medical devices will be required to undergo the licensing process for medical devices.
The major documentation required for the licensing process is:
Since international manufacturers would not have any knowledge of medical devices registration in India, they can appoint an “authorized agent”. An authorized agent is an establishment in India who will be responsible for all business activities of the international manufacturer and act as a point in India so as to ensure compliance to all the rules laid out in the Drugs and Cosmetics Act, 1940.
There are many benefits for international manufacturers by the Indian authorized agent. A few of them are:
In conclusion, India being one of the leading medical devices markets in the world, it is of prime importance that stringent regulations are laid to ensure patient safety. The CDSCO has hence, laid out these legislations and updates in order to oversee the smooth and integral use of medical devices to meet the healthcare needs of patients across the country.
The CDSCO licensing procedure is a complex and time-consuming process but holds multiple benefits for the manufacturer such as brand recognition, launch of high-quality products that are compliant with industry norms, regulatory compliances, and also helps to broaden market access. Hence, an authorized agent such as CliniExperts can help smoothen the registration process, and make it hassle-free and fast..
https://cliniexperts.com/regulatory-update/class-c-class-d-medical-devices-regulatory-update-2023/
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