Cdsco India authorized agent for medical devices Role and Responsibilities

 Cdsco India authorized agent for medical device is an individual/organization that is granted Power of Attorney by the Foreign Manufacturer who needs to Register/ Sale their Medical Device in India. Foreign Manufacturers of Medical Devices who need approval and disperse their Medical Device (those regulated by CDSCO) in India should delegate an Indian Authorized Agent.

The Indian health care market is rapidly becoming an attractive market for medical device manufacturers. The Cdsco India authorized agent for medical device is governed by the drug and cosmetics act 1940 and rules 1945. The Cdsco is responsible for the regulation of medical devices in India. The Indian health care market is quickly turning into an appealing business sector medical device manufacturers. The Cdsco India authorized agent for medical device is administered by the drug and cosmetics act 1940 and rules 1945. The Cdsco is responsible for the guideline of medical devices in India

Cdsco India authorized agent for medical device for all Classes:

1. Appoint an India Authorized Agent to work with the CDSCO on your behalf. This agent must have valid licenses to obtain the label of Power of Attorney in order to legally manage the progression of your device’s registration and importation in India.
2. Complete device registration application, which includes the device’s technical information, manufacturing facility information (to register the facility/facilities being used to produce the device), ISO 13485 certificate, IFU, and any testing results and clinical data. In addition, provide proof of approval from the United States, Australia, Canada, European Union, and/or Japan, as well as proof of approval in the device’s country of origin (if applicable). All documents should be in English.
   
3. Send applications to the CDSCO and pay the application fees.
4. If approved, the CDSCO will issue a Registration Certificate. Although this certificate does not expire, fees are required to be paid every five years in order to maintain the validity of the certificate.
   
5. Once the certificate is obtained, your product’s India Authorized Agent may import products into India!

Cdsco India authorized agent for medical devices Role and Responsibilities:

• Must be a resident of India with experience in the healthcare industry.
• Holds the power of attorney to submit medical device registration documents to CDSCO.
• Must hold Drug Wholesale licenses 20-B and 21-B.

The Indian Medical Device Regulations are dynamic and are being made more stringent day by day. There are 37 categories of devices that are currently notified and regulated by the CDSCO in India. More device categories are being brought into purview of the CDSCO regulation in coming years. 

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device