Chang-Hong Whitney11.11.08
In July/August 2007, this column reported that the State Food and Drug Administration (SFDA) would be required to report to the MOH, following a decision made at the last People’s Congress (see “A Look at the Medical Reimbursement System in China,” available at www.mpo-mag.com). The final administrative responsibilities of the SFDA recently were outlined: The agency will maintain all of its controls on medical devices, drugs and cosmetics, but give large portions of food management to the MOH and other agencies.
In more recent SFDA news, on July 23, the SFDA issued a new interim regulation that aims to update, strengthen and standardize existing product registration requirements for medical devices.
The most significant point mentioned in this regulation is related to re-registration, or registration renewal. The SFDA requires medical product registrations to be renewed every four years. The past regulation required repeat testing at renewal. The new rule removed the testing requirement if the manufacturer states that there has been no change to the product within the past four years since the product registration was last issued. If there is a change, only the changed items are to be evaluated by the SFDA authorized testing center.
This regulation did not give much detail on what “changes” are considered critical and, therefore, would require testing. Consultation with the SFDA’s registration acceptance office has yielded different answers as well. Thus, more detailed implementation procedure should be expected in the coming months.
Other clarifications included in this announcement include:
• An electronic copy of the user manual and product standard must be provided along with the hard copies of both documents at time of registration
• Registration documents that contain obvious mistakes, wrong information or inadequately demonstrate effectiveness and safety of a product will be rejected for registration
• To enforce the legal impact, the SFDA also requires that the statement of truthfulness and the authorization of legal agent for foreign manufacturer be notarized by the manufacturer.
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The above summarizes a few events in the Chinese healthcare and medical regulatory field this summer. The next column will explore the healthcare markets in China to a greater extent.