CDSCO Compliance (Central Drugs Standard Control Organisation)
Navigate Drug & Medical Device Regulatory Compliance in India
- Understand CDSCO regulatory requirements applicable to your product
- Prepare documentation for drug and medical device compliance
- Align your quality systems with Medical Devices Rules, 2017
- Navigate registration and licensing procedures with expert guidance
The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority of India, functioning under the Ministry of Health & Family Welfare. It is responsible for the approval of new drugs, oversight of clinical trials, laying down regulatory standards, and — through the Medical Devices Rules, 2017 — the registration and licensing of medical devices manufactured, imported, or sold in India.
Any organization that manufactures, imports, or distributes drugs or medical devices in India is required to comply with CDSCO regulations, which are enforced alongside state-level licensing authorities under the Drugs and Cosmetics Act, 1940 and its associated rules.
SIS Certifications is a private ISO certification body and does not issue CDSCO licenses or act as the government regulator. What we do provide is regulatory-compliance advisory support — helping organizations understand applicable CDSCO requirements, prepare the technical and quality documentation regulators expect, and build the underlying quality management systems, such as ISO 13485, that CDSCO compliance is typically built upon.
Benefits of CDSCO Compliance
Regulatory Clarity
Understand which CDSCO rules, classifications, and licensing routes apply to your product.
Documentation Readiness
Prepare technical files and quality records aligned with CDSCO documentation expectations.
Risk Reduction
Reduce the risk of delays or rejections caused by incomplete or non-compliant submissions.
Market Access
Support a smoother path toward lawful manufacture, import, or sale of regulated products in India.
QMS Alignment
Build quality management practices consistent with ISO 13485 alongside CDSCO expectations.
Ongoing Guidance
Get continued support as CDSCO regulations and classification lists evolve over time.
Certification Process
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