The Central Drugs Standard Control Organization (CDSCO) has issued a circular directing all procurement agencies — including hospitals, government bodies and health institutions — to strictly ensure that only licensed medical devices are purchased in India, as mandated under the Medical Devices Rules (MDR) 2017.
The circular notes that several agencies have been insisting on USFDA or CE certifications during tenders, even though Indian regulations already require a valid CDSCO or State Licensing Authority (SLA) license for import, manufacturing, sale and distribution of any medical device in the country.
Under the Medical Devices Rules, devices are classified into four categories based on risk:
• Class A: Low risk
• Class B: Low–moderate risk
• Class C: Moderate–high risk
• Class D: High risk
Licensing responsibilities are split between State/UT authorities (for Class A & B manufacturing and sale) and CDSCO (for Class C & D import and manufacturing after technical and quality review).
CDSCO has instructed all procurement agencies to make licensing under MDR 2017 a mandatory requirement in technical bids. While foreign certifications may be submitted additionally, they cannot replace the Indian licensing requirement.
This directive aims to strengthen regulatory compliance and standardize procurement practices across healthcare institutions to ensure device quality and patient safety.
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