What is a Certificate to foreign government FDA?

 

Certificate to foreign government FDA is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories. A CFG confirms that your device has been cleared or approved for sale in the US. You can present your CFG to regulators in these markets as part of your medical device registration process. 

Before certain medical devices can be lawfully exported from the United States, some countries require American companies to obtain a Certificate to foreign government FDA (CFG). The FDA recently issued a final guidance titled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices,” which details how to seek review of the denial of a CFG request, as well as the reasons the FDA will deny such a request and how to rectify them.

What is a Certificate to foreign government FDA?

If you have a medical device that is registered and listed with the US FDA, then you can obtain a Certificate to Foreign Government from the US FDA.A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States. Regulatory bodies in some countries request a “Certificate of Free Sale.” Still, these are issued by the US FDA for foods, while the agency issues Certificates to Foreign Governments for medical devices. 

The name of the certificate is not the same for all countries, and regulators use the terminology most familiar to their country.  A Certificate to foreign government FDA (CFG) is, for the export of medical devices that can be legally marketed in the United States (U.S.) that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.

Read More -  Certificate to foreign government FDA 

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

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   

MDCG Guidance for Class I Medical Devices

MDCG Guidance for Class I Medical Devices has now (finally) published its guidance MDCG 2020-2 on the subject, which confirms everything in that blog in terms of the mechanics of timing, but adds important procedural requirements for a class I manufacturer about how to actually document things, what the state of the technical file and QMS should be and what the declaration of conformity should look like, because these are things that manufacturers of class I devices often do not right.

MDCG Guidance for Class I Medical Devices The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to provide medical device manufacturers and other parties involved with recommendations regarding compliance with the applicable regulations in the context of MDR postponement. 

MDCG Guidance for Class I Medical Devices

The MDCG enlists tasks to be carried out by a Class I manufacturer to ensure compliance with the MDR: Ensure that the device is accompanied by the information needed to identify it and its manufacturer, and any safety and performance information relevant to the user, or any other person, as appropriate.

Implement a post-market surveillance system in accordance with Article 83 (Article 10(10)) proportional to the risk class and appropriate for the type of device, this includes additional aspects to be taken into account in case of devices placed on the market in sterile condition, with a measuring function or that are reusable surgical instruments. This system will be an integral part of the manufacturer’s quality management system based on a post-market surveillance plan.

Implement a system for recording and reporting incidents and field safety corrective actions. Put measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC3 , without prejudice to more protective measures under national law. These measures will be proportional to the risk class, type of device and the size of the enterprise.

“For devices which are currently certified with respect to the Directive 93/42/EC, and for which the available clinical data are not sufficient to demonstrate compliance with MDR, additional clinical data may be obtained by post-market clinical follow-up studies of the device. Sometimes, even data from the general post-market follow-up might suffice to close the gap.

The MDCG Guidance for Class I Medical Devices says “duly justified and substantiated cases,” some Class I device manufacturers “may exceptionally demonstrate that the conformity with general safety and performance requirements based on clinical data is not deemed appropriate. Such a justification by the manufacturer must be based upon an evaluation of evidence in accordance with Article 61(10). 

Read More - MDCG Guidance for Class I Medical Devices 

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

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