The various specific categories of IVD and MD that required license before being sold in India were clearly explained in the IMDR-2017.

These rules to some extent are in harmony with the global regulations on medical devices. They eliminated some ambiguities that existed earlier.

The Central Licensing Authority (CLA), that is the CDSCO started to control the importation for all notified medical devices (Class A, B, C & D) and manufacturing licenses associated with only high and moderate risk devices and IVDs (Clase C & D). The low-risk devices and IVDs (Class A & B) manufacturing License were now controlled by the State Licensing Authorities. The concept of notified bodies was introduced, who were private entities that were registered with the CDSCO to perform audits at Manufacturing Sites to ensure compliance to the IMDR and stated quality requirements stated therein in Fifth Schedule of the IMDR 2017.

In February 2020 amendment to the IMDR 2017 was introduced via GSR 102 (E) and GSR 648(E), which release the definition of Medical Device and clarified that if the product meets the definition and was not on the ‘notified’ list it would be considered as ‘non-regulated’, but would still require to be registered voluntarily on the medical device online portal. (https://cdscomdonline.gov.in/NewMedDev/Homepage ).

Until October 1^st, 2023, the software associated with medical devices was not regulated, but after this date even the software as medical device (SaMD) is now regulated and required to be evaluated and licensed before commercialization.

As the law stands today, all the MDs and IVDs are regulated in India and should have a license before they are commercialised. The post marketing safety follow-up data is required to be submitted throughout the lifecycle of the product.

General overview of the regulatory process:

1. Regulatory Classification: Determine the appropriate regulatory classification for IVD/MD as per Medical Device Regulatory MDR guidelines 2017.

In India, IVD or MDs are classified based on risk into four classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). This classification will help determine the regulatory requirements that need to be fulfilled.

2. Obtain an Import License for Devices that have Predicate in India: The interested party must get an import license from the Central Drugs Standard Control Organisation (CDSCO) if the IVD or MD is being brought the into India for a commercial launch. This license allows the importer to import and sell distribute the device in India. If the product is already approved in the GHTF countries all the regulatory documents, quality certificates and the free sales certificates and device technical dossier should be submitted.

The Test License in MD-16 (Import License Application for Testing) or MD-12 (Application to Manufacture for Testing) using the National Single Window System (NSWS) to do in house substantial equivalence studies may be requested before the commercial license application is filed.

3. Devices that do not have Predicate in India- Such devices need to go through the clinical investigation after approval is obtained for the clinical investigation in MD-23 (in case of MD) and Clinical Performance Evaluation in MD-25 (in case of IVD) and when proven to be safe and effective can be commercialised in India after obtaining the Import /Manufacturing License for Sales and Distribution. However, First in Human Clinical Investigations for a product developed outside India are not permitted in India. In that case available human data from the country of origin or any foreign land should be available before such devices are evaluated in clinical study in India.

4. Authorised Indian Representative (if applicable): If a foreign manufacturer who does not have a base in India, the entity should appoint an authorized representative based in India who will act as a representative of the foreign manufacturer to the Indian Regulatory Agency. The Indian Agent should be provided with a Power of Attorney by the foreign manufacturer and also should have a valid wholesale license (Forms 20B and 21B/21C) in order make the registration applications for importation and manufacture of the devices for sales and distribution in India.

5. Essential Principles Assessments: The MD/IVDs should comply with the Essential Principles for safety and performance.

6. Technical Documentation: Technical Documentation for MD and VD should be prepared based on XX as per the IMDR 2017.

7. Quality Management System: The manufacturer should have ISO 13485:2016 Certification for the Quality Management Systems.

8. Clinical Performance Evaluation (if applicable): If the IVD or MD falls under novel device not having a predicate we may need to undergo clinical investigation/performance evaluation studies to illustrate the safety and effectiveness of the device.

10. Apply for License: Submit the registration application for the IVD or MD to the CDSCO using the medical device Sugam online portal. The application should include all relevant technical documentation, labelling as per the IMDR 2017, and evidence of conformity assessment (if applicable).
11. Review and Approval: The CDSCO reviews the application, technical documentation, and other supporting data. They might ask for more information or clarification during the review process. If everything is in order, and the device meets the regulatory requirements, the CDSCO will grant registration approval.
12. Post-Market Surveillance: This is known as Materiovigilance, a coordinated system for identifying, collecting, reporting, and analyzing any adverse events related to the use of medical devices and protection of patient’s health by preventing its recurrences. continues throughout the entire product lifecycle.