The Indian medical device industry has been recording significant growth and ranks in the top 20 markets for medical devices worldwide. It is estimated to reach USD 50 billion by 2025 from that of USD 10.36 billion in 2020. The Central Drug Standard Control Organization (CDSCO) regulates medical devices marketed in India and ensures to initiate and implement Regulatory frameworks for proper compliance of medical devices.

On February 11, 2020, the CDSCO has released two Gazette notifications, which are effective from April 1, 2020. The notifications are referred as Medical Devices (Amendment) Rules, 2020.The key highlights of these notifications include:

1. New Definition of Medical Devices - As per this notification, all the medical devices will be regulated as drugs by the CDSCO.
2. Registration of Newly Notified Devices - A new chapter is introduced for the registration of Newly Notified Devices. After this notification, the medical devices in India are categorized as follows:

• Notified Devices - These include the list of 37 categories of medical devices. These devices were already regulated in India and requires prior approval from the CDSCO to be marketed in India.
• Newly Notified Devices - Prior to the amendment, all devices other than the Notified Devices were considered as non-notified devices. The newly introduced devices by the CDSCO through this notification are called as, “Newly Notified Devices”. In September 2020, the CDSCO has released a notice classifying these medical devices and IVDs into 24 categories.

As per the amendment, manufacturers (both domestic and foreign) are required to mandatorily register the Newly Notified Devices with the Central Licensing Authority through an identified online portal established by the CDSCO. This amendment provides exemption to the already regulated 37 categories of medical devices under “Notified devices” from the registration process.

Requirements for Registration and Obtaining License of Newly Notified Devices

The registration of newly notified medical devices is not mandatory but is voluntary till October 1, 2021. Manufacturers and importers must have all the newly notified medical devices registered by October 1, 2021. This registration does not involve detailed review by the CDSCO. However, the newly notified devices eventually should obtain prior approval and licenses from the CDSCO to continue marketing. The Agency has varied transition timelines for different risk classes as listed in the table below:

Registration Process for Newly Notified Devices

1. Manufacturers should upload the required information on “Online System for Medical Devices (SUGAM Portal)” established by the CDSCO. The applicants should submit the information about manufacturer, manufacturing site, medical device (Generic name, Model number, Intended use, Class of Medical Device, Material of construction, Dimension (if any), Shelf life, Sterile or non-sterile, Brand name), ISO 13485 Certificate along with the undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
2. Importers should submit all the information listed above. Additionally, they should also submit a Free Sale certificate from the country of origin.
3. The manufacturer or the importer is required to mention the registration number on the label of the medical device after the above information is uploaded.
4. The safety and quality of the medical devices may be investigated by the Central Licensing Authority by verifying the documents at any point of time.

The newly established rules for mandatory registration ensure that all the devices marketed in India are regulated by the CDSCO and ensure that safe and effective devices are made available for the use to the public. The manufacturers and importers must ensure that all the newly notified medical devices are registered within the transition timelines for continued market access. Therefore, this is the right time for the manufacturers and importers to initiate the necessary activities to register their newly notified medical devices in the CDSCO portal. Act now to meet the defined deadlines. Choose a proven Regulatory partner. Stay informed. Stay updated.