Guidance for Product Registration

The China’s regulatory device system is complex, and not yet transparent or consistent. There are two registration requirements: SFDA (formally FDA) and CCC.

State Food and Drug Administration (SFDA)

Under the March 2003 structural reforms of the Chinese bureaucracy, China’s State Food and Drug Administration (SFDA) responsibilities expanded to include Food and cosmetics. All imported medical devices to be sold in China must be registered with SFDA. Local type-testing is required for class II and III medical devices before registration. Clinical trials are required to be included in registration applications for certain class II and III products. These regulations will be revised in the near future.

The registration requirements are:

1. Qualification Certificate for the manufacturer
2. Qualification certificate of applicant ( If not same as manufacturer )
3. Certificate from Country of Origin indicating device can be used in that country

Medical device manufactures must provide the following documents:

1. Instruction manual
2. Type test report, issued within past year by SFDA Qualified Institute
3. Clinical trials reports (at least two clinical trials within past year)
4. Statement guaranteeing product quality
5. Letter authorizing after-sale service agency and a letter of commitment including the business license of agency
6. Statement of authenticity of materials submitted
7. Local clinical trials are required for implantable products Other documents as may be required by SFDA

CCC Mark Application Process

China Compulsory Certification (CCC) safety certification is requested for electro – medical products a CCC mark is required. A quick summary of the CCC mark requirements can be found at: http://www.mac.doc.gov/China/cccguide_sub.htm

Tradeology Guidance

Tradeology USA assists its clients and business partners in complying with all Chinese regulations, including SFDA and CCC. We are always current with respect to each of the Compliance Agencies and have substantial know how in dealing with changes in procedures and requirements for western manufactured products.

Tradeology USA has extensive experience with all the SFDA and CCC certification processes including intimate knowledge about the SFDA head office (SDA/CMDE) State Food Drug Administration / Center for medical Device Evaluation Deputy Directors.

In addition, we have personally dealt with each of the Directors of the main SFDA Testing Centers including Beijing, Wuhan and Jinan. This includes the Beijing Center (Director of Center of Medical Devices, National Institute for the control of Pharmaceutical & Biological Products, President of Chinese Biomaterials Society, and Member of American Society for Biomaterials.)

Also, since 2002, Tradeology USA has partnered with a major Chinese organization as their registration agent in the Chinese market. This company has won SFDA and CCC certification for most of the largest manufacturers of medical devices.

Bottom line is that you can trust that the knowledge is there to get your product testing completed!