Mandatory CDSCO Registration for Class A Devices in India
On October 14, 2022, the Ministry of Health and Family Welfare issued a notification to exclude all Class A (non-sterile and non-measuring) devices from licensing requirements. The manufacturer and importer of Class A (non-sterile and non-measuring) devices needs to register their devices on CDSCO.
After submitting the required information to the Sugam Portal for Medical Devices, the applicant will receive a registration number. The manufacturer and importer must include the registration number on the label of the medical device.
Regulatory Authority of Medical Devices in India
India’s foremost authority in overseeing the landscape of Medical Device regulations is the Central Drugs Standard Control Organization (CDSCO). This esteemed organization shoulders the responsibility of granting licenses for both the importation and domestic production of medical devices within the nation.
Steps to CDSCO Registration for Class A Devices
- Go to the CDSCO SUGAM Portal for Medical Devices https://cdscomdonline.gov.in/.
- Click on the “Registration” link.
- Register with a valid email address and mobile number.
- Upload the following documents:
- ID proof
- Undertaking
- Corporate address proof (certificate of incorporation)
- Copy of manufacturing license and wholesale license (if applicable, or justification for not having them)
- Verify your registration using the OTP received on your mobile phone.
- Log in to the portal and proceed with the CDSCO Voluntary Registration process.
Need help with CDSCO Registration for Class A Devices?
Contact MedDev Experts, an experienced medical device consulting company in India. We can help you to register your medical devices in India with the CDSCO.
Required documents for CDSCO Registration for Class A Devices for Manufacturer
- Name and address of the company manufacturing the medical device, as well as the name and address of the manufacturing site
- Details of the medical device, including generic name, model number, intended use, class, material of construction, dimensions, shelf life, and whether it is sterile or non-sterile
- Certificate of compliance with the ISO 13485 standard accredited by the National Accreditation Board for Certification Bodies (NABCB) or the International Accreditation Forum (IAF).
- Undertaking duly signed by the manufacturer stating that the proposed device is a Class A (non-sterile and non-measuring) medical device.
- Self-certification by the manufacturer stating that the product is conforming to the essential principles checklist of safety and performance of the devices.
- Self-certification by the manufacturer stating that compliance with the standards specified in Medical Device Rules, 2017.
- Undertaking duly signed by the manufacturer stating that the information furnished is true and authentic
Required documents for CDSCO Registration for Class A Devices for importer:
- Name and address of the importer of the medical device.
- Details of the medical device, including generic name, model number, intended use, class, material of construction, dimensions, shelf life, and whether it is sterile or non-sterile
- Certificate of compliance with the ISO 13485 standard accredited by the National Accreditation Board for Certification Bodies (NABCB) or the International Accreditation Forum (IAF).
- Undertaking duly signed by the importer stating that the proposed device is a Class A (non-sterile and non-measuring) medical device.
- Self-certification by the importer stating that the product is conforming to the essential principles checklist of safety and performance of the devices.
- Self-certification by the importer stating that compliance with the standards specified in Medical Device Rules, 2017.
- Self-attested copy of the overseas manufacturing site or establishment or plant registration, in the country of origin issued by the competent authority.
- Free Sale Certificate issued by the National Regulatory Authority from the country of origin.
- Undertaking duly signed by the importer stating that the information furnished is true and authentic
CDSCO Registration Number
The registration number for Class A (non-sterile and non-measuring) medical device will be generated after furnishing the information on the CDSCO SUGAM Portal for Medical Devices. The manufacturer and importer must include the registration number on the label of the medical device.
Medical Device Licensing Services by MedDev Experts
We offer a comprehensive suite of medical device licensing services in India, including:
- Medical Device Registration and License
- Medical Device Import License
- Medical Device Wholesale License
- ISO Certification
- GMP Compliance
- FDA Product Listing
- 510(k) Submission
- CE Documentation
- BIS Certification (ISI Marking)
- Import License for Cosmetic Products
- Medical Device Labeling Compliance
- Cosmetic Import License from CDSCO
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