Regulatory Licensing Support
Licensing and regulatory approvals are the critical “gatekeepers” for the medical device and pharmaceutical industries. They ensure that products meet stringent safety, quality, and efficacy standards before they can be manufactured, imported, or sold.
Primary Medical Device Licensing (CDSCO)
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The Central Drugs Standard Control Organisation (CDSCO) is the central authority in India for regulating medical devices under the Medical Devices Rules, 2017.
• CDSCO Manufacturing License (MD-5 / MD-9): This is the primary authorization to produce medical devices in India.
o MD-5: Issued by the State Licensing Authority (SLA) for lower-risk Class A and Class B devices.
o MD-9: Issued by the Central Licensing Authority (CLA) for higher-risk Class C and Class D devices. -
• CDSCO Import License (MD-15):
To legally bring any medical device into India, an authorized Indian agent must obtain this license. The process begins with an MD-14 application via the SUGAM portal, requiring documentation like the Device Master File (DMF) and a Free Sale Certificate from the country of origin. -
• CDSCO Loan License (MD-6 / MD-10):
This allows a company to manufacture devices using the licensed facility of another manufacturer.
o MD-6: For Class A and B devices.
o MD-10: For Class C and D devices.
Market Expansion & Export Certificates
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• Free Sale Certificate (FSC): ): An essential export document issued by the CDSCO (for Class C/D) or SLA (for Class A/B) certifying that the product is freely sold in the Indian market and meets local regulations.
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• Market Standing Certificate:
Confirms that a manufacturer has been selling the product in the market for a specific period (usually 2–3 years) with a clean safety record, often required for government tenders.
Global Market Access
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• CE Marking (EU MDR/IVDR): ): Mandatory for selling in the European Union.
o EU MDR 2017/745: Covers general medical devices. .
o EU IVDR 2017/746: Covers in-vitro diagnostic devices. -
• USFDA Approval (510k):
A premarket submission to the FDA to demonstrate that a new device is "substantially equivalent" to a legally marketed device in the U.S.
Quality & Specialized Standards
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• WHO-GMP / CDSCO (Pharma): ):Compliance with Good Manufacturing Practices (GMP) is the baseline for pharmaceutical manufacturing, ensuring products are consistently produced and controlled.
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• BIS Approval::
The Bureau of Indian Standards (BIS) provides product-specific certifications for certain medical equipment (like X-ray tubes or thermometers) to ensure they meet Indian quality specifications. -
• ZED Certification:
The "Zero Defect Zero Effect" certification is a scheme by the Ministry of MSME to encourage manufacturers to reduce waste and environmental impact while improving quality