Medical Device Registration
MEDICAL DEVICE REGISTRATION AND APPROVAL IN INDIA WITH CDSCO ( FORM 41/FORM 10)
Classification of medical devices and invitro diagnostics medical devices follow an internationally accepted, risk based approach. Based on the anticipated risk for the intended use, both, medical devices and in vitro diagnostics medical devices are classified either as;
- Low Risk – Class A
- Low Moderate Risk – Class B
- Moderate High Risk – Class C and
- High Risk Class D
The imported medical devices need to follow the registration process with CDSCO. Medical device registration certificate in Form 41 and import license in form 10 are required under the Drugs & Cosmetics Rules. Once the regulatory Design dossier is submitted by CDSCO the review will take place on the submitted documents and queries if any will take place on the submitted documents and queries if any will be sent to Authorized Indian agent for clarification and response.
Isha’s GMP Consultancy provides integrated end to end product categorization services, Medical device registration service as well as Indian Authorized agent services to all importers and manufacturers of medical devices & IVD’s our service offerings will help you import, manufacturer, test, conduct clinical trials and distribute your products in India ( Market authorization ) to accelerate your market entry through faster approvals.