New vs. Old

Comparing the previous regulation and the new draft, the latest regulation under consideration is much more comprehensive and detailed. In general, it has gathered separate regulations issued through the past six years into one document. The 2000 version has a total of five chapters and 47 articles pertaining to general administration; the administration of medical devices; manufacturing distribution and usage of devices; supervision; and penalties for violations. The revised draft now consists of 11 chapters and 126 articles. Newly added chapters include Management of Medical Device Import And Export, Management of Medical Device Advertisement, Supervision of Medical Devices (such as product recall and adverse incident reporting) and Technical Management and Quality System Supervision for QMS [quality management system] Assessment and Product Testing.

Key improvements to previous regulations include the following:

• Enhanced supervision in all aspects of medical device management—from manufacturing and distribution to usage—to ensure safety and compliance. The new regulation designates manufacturers and distributors as the primary parties responsible for the medical products they make and sell. Stringent QMS and tracking requirements are outlined for these parties.

• Improved review and evaluation of product registration. For example, Class I domestic product registration will be reviewed by a provincial SFDA office instead of one at the city level, which is the current protocol. In addition, the provincial SFDA would have to perform an initial technical review for Class II and III products before submitting registration applications to the state office. This regulation shortens the review time for imported Class I registration to 40 business days but fails to specify the entire review timeframe for Class II and III products, leaving room for future determination by the SFDA on registration reviews.  

• Product registration made valid for five years, instead of four years under current regulation, and requiring registration renewal to begin six months prior to expiration. Products that are not registered or not renewed within this timeframe would be considered unregistered and, therefore, not be available for sale on the market.

• Formal installation of adverse-event reporting, product recall notices and tracking mechanisms for all medical devices. Besides requesting that manufacturers and distributors maintain product records, this regulation was expanded to request that end-users of medical devices—eg, hospitals—maintain records of products purchased. Critical information such as the manufacturer’s name, product serial number, manufacturing date, lot number, validity date, etc. should be maintained two years beyond the life of the product.

• The addition of import and export management for medical devices, with further implementation details to be jointly developed by the SFDA and the Administration of Quality Supervision Inspection and Quarantine (AQSIQ). In June 2007, the AQSIQ announced a policy requiring imported products to be tested prior to importation. This regulation will be in effect starting Dec. 1. The AQSIQ and SFDA will determine the list of products that must be tested at importation.

• Specification of higher penalties for violations and non-compliance. For example, any violation by a manufacturer (manufacturing without a proper license, without passing QMS inspection or without product registration) will carry a penalty of 10 to 20 times the product’s value based on severity of the violation. Distributors that sell products without product registration or proper distribution permit will face a fine of five to 10 times the product’s value and possibly have its distribution permit suspended.

• Introduction of device safety and efficacy requirements and concepts, aiming at using safety and effectiveness as the core of evaluating products instead of relying on technical standards and industrial standards. This regulation introduced a design-review requirement for imported products but did not specify the details of such inspection, except the inclusions of a sentence noting that the design review could be conducted along with the QMS inspection.

• A request that clinical trials be registered with provincial, regional or municipality FDA offices before commencing. Clinical trials for high-risk products must be registered with the SFDA before execution. In addition, this regulation has installed a supervision clause for provincial or state FDA offices to inspect trial sites or monitor trial progress. Violations of ethics or falsifying trial results carry a stiff penalty of 10,000 to 20,000 RMB (or $1,300 to $2,600 at the current exchange rate) as well as a risk of suspension of clinical trial activities for two years or longer.