CDSCO Registration for Medical Devices in Delhi
For any medical device which is manufactured in India, it’s mandatory to have a CDSCO Medical Device Manufacturing License.
For Class A and B medical devices, manufacturing licenses will be issued from the State Licensing Authority. A manufacturing license is effective for Class A and B from 1st October 2022. For Class C and D medical devices, manufacturing licenses will be issued from Central Licensing Authority. CDSCO manufacturing license will be effective for all non-notified Class C and D from 1st October 2023.
Operon Strategist provides consulting for CDSCO manufacturing license in Delhi
For any medical device which is imported to India, it’s mandatory to have a CDSCO Medical Device Import License.
Operon Strategist provides consulting for CDSCO Import license in Delhi.
Looking for Medical Device Registration in Delhi?
Contact us to get expert consultation on the CDSCO registration process.
Operon Strategist Step-by-step Approach for CDSCO Medical Devices Registration in Delhi
- Classification of Medical devices as per CDSCO regulation
- Online CDSCO Login Credential
- Preparation of technical file as per CDSCO regulatory compliance
- Review of documents by our technical experts,
- Submission of documents to the online CDSCO portal,
- Guidance on online payment to CDSCO and
- Resolving CDSCO queries if any.
FAQ's
What is CDSCO registration for medical devices?
CDSCO registration is the regulatory process by which medical devices are approved for sale in India. It is managed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
Who needs CDSCO registration for medical devices?
Manufacturers, importers, and distributors of medical devices marketed or intended to be marketed in India must register their devices with CDSCO, unless exempt under specific rules.
What documents are needed for CDSCO registration?
Commonly required documents include device classification evidence, technical specifications, test reports, manufacturing licenses, IEC certificates, quality certificates (ISO 13485), and proof of local agent or importer details.
Do all medical devices require CDSCO registration in India?
Most medical devices require CDSCO registration, but some may be exempt based on classification or specific regulatory notifications. It’s important to confirm eligibility before applying.