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July 1, 2025
Approximately 5 minutes
India's Central Drugs Standard Control Organisation (CDSCO): Regulator, Compliance, and Market Access
India's Central Drugs Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) and the primary body responsible for regulating all medical devices, IVDs, and drugs in India. Based in the Ministry of Health & Family Welfare, the CDSCO oversees the entire lifecycle of medical devices, from import and manufacture to sale and distribution, ensuring compliance with standards for safety, quality, and efficacy.
⚙️ Role in Medical Device Registration
For foreign manufacturers, the CDSCO is the issuer of the required market authorization: the MD Form 15 Import License. This license is site-specific, meaning a manufacturer with multiple production facilities will require a separate MD-15 for each site.
- Application Process: The Import License is granted upon approval of the MD-14 application, which requires the submission of a Plant Master File (PMF) for the manufacturing site and a Device Master File (DMF) for the product.
- Compliance Checks: The CDSCO conducts inspections and audits to ensure manufacturing facilities comply with quality system regulations (e.g., ISO 13485).
📈 Significant Regulatory Updates
The CDSCO has been actively reforming its regulations, primarily through the Medical Device Rules, 2017 and subsequent amendments, to expand its regulatory scope:
- Mandatory Import Licenses: As of October 1, 2023, all Class A (Measuring/Sterile), Class B, Class C, and Class D devices require an MD-15 Import License for importation. Class A Non-Measuring/Non-Sterile devices are exempt from the Import License process but still require mandatory online registration and self-certification.
- Online Registration Portal: The launch of an online registration portal has streamlined the application submission process.
- New Rules: The introduction of the Medical Device Rules, 2020 replaced the 2017 rules (in part), further clarifying the regulatory landscape.
⚠️ Compliance and Market Access
To successfully enter and operate in the Indian market, foreign companies must work with a local entity (the License Holder) to ensure ongoing compliance:
- License Holder Responsibility: The local License Holder is the official interface with the CDSCO and is responsible for managing the Import License, handling customs clearance, and coordinating Post-Market Surveillance (vigilance and adverse event reporting).
- Inspections: The CDSCO performs inspections and audits to verify compliance with safety and quality regulations.
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