Regulatory Affairs

/Regulatory Affairs
Regulatory Affairs 2017-07-02T19:07:46-04:00

Capturing the Chinese market begins with CFDA product registration.

Whitney Consulting provides the following Registration Service:

  • CFDA Registration – medical product registration with China Food and Drug Administration
  • Wireless Compliance
  • CCC Mark – China Compulsory Certification for Electronic products

CFDA Registration

All medical products entering the Chinese market require product registration with China Food and Drug Administration. Based on product application and risks, products are categorized into three classes. Class I is the least risky product while Class III is the most risky product. Class II and III products require in-China testing. If they are in vitro diagnostic (IVD) products, in-China clinical evaluation is required.

Whitney will manage each registration project from its Beijing office. A project leader is assigned and will be responsible to all aspects of a project till the registration is completed, i.e. registration certificate is received.

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Wireless Compliance

As wireless and radio transmission technologies become more common in the everyday life, many companies have adopted the technologies in their products to provide the capability of remote monitoring and patient access. It is more and more common to see products that can transmit patient data using WIFI, cellular network and Bluetooth technologies. Some products transmit the patient data to a cloud storage automatically so a physician can download remotely for analysis, diagnosis, even apply treatment remotely. But others require downloading to another device, which then transmit to a server. Nearly all such transmissions utilize the existing public wireless network, therefore require specific approvals from the Chinese government that governs radio transmission and Network Access.

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With China joining the World Trade Organization (WTO) in December 2001, China announced a new set of laws concerning product safety on imported products. The new Compulsory Product Certification System (CPCS) and a new CCC Mark replaced the previous Standardization Law (CCEE Mark) and the Law on Import and Export Commodity Inspection (CCIB Mark). The CPCS became mandatory on May 1, 2002 and officially became effective from August 1, 2003 .

Any product covered by the CCC Catalogue ( should have the certificate before it can be marketed, imported or used for any commercial purposes.