| CDSCO Import License for Medical Devices |
Medical Device Import License:
Applicable when we have to CDSCO Import License from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries.
Operon Strategist assists pharma or medical device distributors and medical device wholesalers in India to procure CDSCO import license. An Import license is issued for import of medical device from other country to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.
Medical Device Registration for Import: – Medical Devices entering India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations.
CDSCO Import of medical devices in India Requirements:
- Form41 (Registration Certificate) is required as per requirements of the Drugs & Cosmetic Act.
- Wholesale Drug License in Form 20B & 21B.
- The firm must be registered with the CDSCO Sugam Online System.
Process for Obtaining CDSCO Import License:
For Obtaining an Import License in Form 10, an application in Form 8 and Form 9 is required. Since 1 April 2016, All Applications Should be made through the CDSCO’s Sugam Portal. For more information on the CDSCO’s – Portal for CDSCO Import License and Registration Certificate.
The Different purposes for which an applicant can register under the CDSCO portal are:
- Cosmetics Registration.
- Import or Manufacture of drugs.
- Export NOC (Zone).
- Test License.
- Ethics Committee Registration.
- Formulation R&D Organization.
- Blood Bank Registration.
- Blood Product Registration.
- Dual Use NOC (Trader).
- BA/BE Approved Sites.
- Sponsors (BA/BE and CT).
Read More – CDSCO Import License
Medical devices consultancy 