Chinese medical device market regulators have more clearly defined the responsibilities of in-country representatives and limited exemptions for clinical evaluations in new rules, according to Emergo Group colleagues.

In Administrative Order No. 4, The China Food and Drug Administration (CFDA) has listed the duties of foreign manufacturers’ authorized representatives, known as Legal Agents, as follows:

• Managing communications between Chinese regulators and market entry applicants (manufacturers)
• Forwarding all regulatory and technical requirements to applicants
• Collecting post-market adverse event data and providing that information to applicants and regulators
• Coordinating recalls when necessary and reporting information to regulators
• Managing product quality and after-sales service activities

The CFDA order also formally implements requirements for home-country premarket licensing that had already been practically in force already. Now, a premarket license either from the country or district where an applicant is registered or from the country in which a device is manufactured must be included in a CFDA registration dossier.

Administrative Order No. 4 also ends previous allowances for exemptions from clinical evaluations in China for Class II and some Class III devices with home-country premarket licenses. According to the new order, Chinese clinical evaluation exemptions are permitted in two instances: if the device in question is already listed in the CFDA’s catalogue of devices exempted from clinical study requirements, or if the device’s safety and effectiveness can be demonstrated through the clinical evaluation of a similar device or product.

In addition, some high-risk Class III devices will require CFDA approval before undergoing clinical evaluation.

Stewart Eisenhart