Indian Licensing Now Mandatory for All Medical Device Procurements

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a crucial directive requiring all procurement agencies including government and private hospitals, to ensure that medical devices purchased in India possess valid regulatory licenses issued by CDSCO or State Licensing Authorities (SLA). The circular firmly states that international certifications such as USFDA or CE markings cannot replace the mandatory Indian approval required under the country's laws.

This action follows observations that several hospitals and tendering bodies were prioritizing foreign approvals as core eligibility criteria while neglecting statutory Indian licensing requirements.

The circular underscores that all medical devices sold in the country are governed under the Medical Devices Rules (MDR), 2017, framed under the Drugs and Cosmetics Act, 1940, to ensure the highest standards of quality, safety, and performance. It reiterates that licensing is compulsory for the manufacturing, import, sale, and distribution of any medical device in India.

The notice highlighted, "Kind attention is invited that, the Ministry of Health and Family Welfare has come up with Medical Devices Rule,2017 under the Drugs and Cosmetics Act, 1940 for regulation of Medical Devices in the country to ensure its quality, safety and performance. Currently, all the Medical Devices are regulated under said Rule and a license is a mandatory requirement for its import, manufacturing, sale and distribution in the country. No Medical Devices can be sold in India without valid license obtained from Licensing Authorities. Based on the risk, Medical devices are classified into four categories viz. low risk Class A, low to moderate risk Class B, Moderate to high risk Class C and high risk Class D."

Further, the regulatory responsibilities have been clearly bifurcated: the manufacturing license for risk Class A & risk Class B medical devices and the sale license for all risk classes of Medical devices are issued by the concerned State/UT Licensing Authorities (SLAS); the Import license for all risk classes of Medical devices and the manufacturing license for risk Class C and risk Class D are issued by the Central Licensing Authority, i.e., the Central Drugs Standard Control Organization (CDSCO), based on the detailed technical review and conformance of Quality Management System in the manufacturing of Medical Devices. The applicant shall obtain a relevant license from the Concerned Licensing Authorities for sale and distribution of Medical Devices in the country.

Signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, the circular stresses that no medical device may be marketed or procured in India without a valid CDSCO/SLA license. Procurement entities may still request additional credentials, but only as supplementary criteria.

The circular asserts,

"In light of the above, all the procurement agencies, including Hospitals, Health Institutions, etc., are requested that the CDSCO license or the license issued by the State/UTS Licensing Authority under the Medical Devices Rules, 2017, shall be made mandatory as a part of the requirements for procurement of Medical Devices, without which the medical device cannot be sold in the country. Any other certifications which is required by the procurement agency should be over and above of CDSCO or SLA Licensing Authority approval, under the said rules."

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