Chang-Hong Whitney01.28.08
Regulatory agencies have been busy formulating or implementing new regulations pertaining to medical device and pharmaceutical products. For example, the Ministry of Information Industry (MII) implemented the Administrative Measures on the Control of Pollution Caused by Electronic Information Products—also known as the China RoHS Law (Decree 39)—on March 1, 2007. This regulation requires that labeling for electronic products must list any components that fall into the law’s six categories of hazardous substances. Companies must adhere to this labeling requirement to demonstrate compliance. (For more details about this law, read the January/February 2007 China News column in Medical Product Outsourcing.) Companies have found it fairly easy to comply with this regulation; therefore, implementation has been quite smooth. The MII has formulated requirements pertaining to the amount of hazardous substances that may be used in a product, but to date, the agency has not mandated inspection.
Meanwhile, the State Food and Drug Administration (SFDA) finally released and implemented its much-anticipated new product registration regulation for in-vitro diagnostic reagent products (see China News, June 2007). These products now must be registered as a medical device, but the testing and registration material remains similar to pharmaceutical registrations. Implementation of this regulation has been not been quite as smooth as it was for the MII’s RoHS Law. Ambiguities and problems keep this implementation a bumpy road.
In September, the SFDA also released a new draft of the top regulatory regulation for medical device registrations (see China News, November/December 2007). The Regulation on Supervision and Administration of Medical Devices (Official Draft of Revision of State Council Decree 276) was widely expected by the industry to be revolutionary in removing the pitfalls of the previous regulations. To the dismay of many, however, this new draft fails to address the most sensitive issues, such as registration review time, registration renewal and clinical trials. Instead of simplifying the process, this new regulation makes it more difficult for Chinese companies to register high-risk products. Class III products would be required to be reviewed by provincial FDA offices first before they could be reviewed by the state registration office. Given the lengthy review process and inadequate manpower and capabilities of the local FDA offices, companies view this change as detrimental to their ability to get new products to market quickly. The lack of commitment to improving registration review times also generated a public outcry about the SFDA’s inefficiency and lack of management. Although the first draft of the regulation has been out for months now, the SFDA has yet to incorporate public comments into a second draft.
China’s Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) was busy last year, too, as it issued a new regulation pertaining to imported medical devices. Administrative Measures on Examination and Supervision of Imported Medical Devices (Decree 95) would require that certain high-risk medical products must be inspected before importation is permitted. Ever since the regulation was unveiled last June, the AQSIQ has been bombarded with intense attention from the international medical community, which views the measure as an unfair practice against imported products—as well as a violation of World Health Organization rules. As a result of the vehement objections from governments and trade groups around the world, the AQSIQ has postponed implementation of this regulation indefinitely.
Going into 2008, all the existing regulations described will be further tested and modified to close any loopholes and ambiguities. In addition, the SFDA may release another version of its top-level medical device regulation. Given the complaints by Chinese companies about the agency’s leniency toward foreign producers’ quality systems and design controls, the SFDA may add requirements for foreign manufacturers to prove that they have adequate quality systems and design control processes (certifications such as ISO 13485 and the EC Design Examination Certificate), at the time of product registrations. And, despite the setback on Decree 95, the AQSIQ and China Customs will continue to monitor imported products closely. Inspections on product labeling and document verification certainly will intensify. Companies that are exporting to China need to be extra vigilant in compliance of Chinese requirements—consider yourself forewarned.