Notified Body CDSCO Registration
Registration of notified bodies with CDSCO under the Medical Devices Rules, 2017 — for conformity assessment and audit-conducting organisations. Once registered, the body can inspect Class A and Class B manufacturers on behalf of CDSCO. Requires demonstrated technical competence, a qualified auditor pool, and a documented quality management system aligned with ISO/IEC 17021. Renewals depend on ongoing audit-performance evidence and impartiality reviews.
2 CDSCO forms in this category
Application for Grant of Certificate of Registration of a Notified Body
Application for registration of a notified body under the Medical Devices Rules, 2017.
Certificate of Registration for a Notified Body
Certificate granted to a notified body under the Medical Devices Rules, 2017.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Conformity assessment bodies
Organisations seeking authority to conduct audits and conformity assessments for medical devices.
Technical capability
Demonstrated technical expertise across relevant device categories and standards.
Quality system
Documented quality management system aligned to ISO/IEC 17021 or equivalent.
Documentation checklist
- Organizational structure and ownership
- Quality manual and procedures
- Technical staff qualifications
- Scope of conformity assessment activities
- Independence and impartiality declarations
- International accreditation status (where applicable)
- Insurance and liability coverage
Step by step
- 01
Internal QMS readiness
Implement ISO/IEC 17021-aligned QMS and document scope.
- 02
MD-1 application
Filed with CDSCO with technical staff and scope details.
- 03
CDSCO assessment
Document review and technical capability assessment.
- 04
On-site audit
CDSCO audits operational capability and impartiality.
- 05
Certificate issuance (MD-2)
Notified body registration granted for defined scope.
- 06
Surveillance and renewal
Periodic CDSCO surveillance to maintain registration.
Common questions
Notified bodies — organisations conducting conformity assessments and audits for medical device manufacturers in India.
Yes, with appropriate Indian operational presence. Existing internationally-accredited bodies often have streamlined paths.
Defined by device classes (A, B, C, D), specific device categories, and standards (ISO 13485, IEC 60601 families, etc.).
Registered notified bodies conduct ISO 13485 and other audits required for manufacturer licensing. They are the third-party audit ecosystem.
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