China FDA Seeks to Improve Medical Device Evaluation at the Provincial and Municipal Government Levels
ADD DATE:2014-4-14 HITS:6
On October 23, 2013, the China Food and Drug Administration (CFDA) released a Guiding Opinion entitled ¡°Increasing the Capacity of Provinces to Conduct Medical Device Evaluations (Guiding Opinion).¡± This Guiding Opinion is part of a larger effort to improve provincial- and municipal-level management of medical device approval and postmarket surveillance. The Guiding Opinion does not apply to approval of imported and Class III devices, which CFDA handles.
In 2012, the State Council (China¡¯s main executive body) released China¡¯s Twelfth Five Year Plan on Drug Safety, which is a policy plan for both drug and medical device reform. Improvement of premarket evaluations of medical devices was one part of that plan. Subsequently, in 2013, the State Council issued an opinion on the improvement of local regulation of medical devices. Following the publication of those national policies, CFDA has issued plans for improving medical device regulatory work of local food and drug regulatory departments at and below the provincial level (often referred to as ¡°local FDAs¡±). For example, earlier in October 2013, CFDA released a document on the improvement of the capacity of local food and drug regulatory departments to monitor medical device adverse events.
The Guiding Opinion
The Guiding Opinion sets forth a ¡°two to three year¡± plan for improving the capacity of provincial and municipal food and drug regulatory authorities to conduct ¡°technical evaluations¡± of the safety and effectiveness of Class I and Class II devices. The provincial level food and drug regulatory authorities evaluate and approve Class II devices that are manufactured in China. Lower-level municipal food and drug regulatory authorities evaluate Class I devices. As noted above, CFDA evaluates imported and Class III devices. Under the Guiding Opinion, CFDA will provide guidance to the provincial and municipal food and drug regulatory departments on technical evaluations of devices. The provinces will provide the appropriate budgetary resources, personnel, and facilities for evaluating devices.
Much of the Guiding Opinion is devoted to ensuring that provinces create appropriate mechanisms to (1) recruit personnel with the appropriate expertise for evaluating medical devices, and (2) ensure that they have the appropriate resources and equipment. The provinces should also develop training programs personnel at the provincial or lower levels. The Guiding Opinion does not specify which types of experts are necessary or what type of training may be required for medical device evaluation.
As for the number of personnel, this has been a longstanding issue in China. Both stakeholders and the Chinese government seem to agree that regulatory authorities in China require a greater number of qualified professionals to properly and timely perform the massive task of approving and supervising the safety of drugs and devices for the country¡¯s thirty-one provincial-level divisions. The Guiding Opinion asks the provinces to recruit the appropriate specialists according to the needs of that particular area. More specifically, the guiding opinion calls for up to two medical device evaluation experts for every 30-50 devices that the province has to approve per year, but if the number does not exceed 30 then only one expert may be needed.
The Guiding Opinion also calls for stronger review procedures and better professional ethics in the local food and drug regulatory authorities. Specifically, it calls for provinces to develop ¡°review procedures¡± and ¡°evaluation standards¡± to guide them in evaluating medical devices. In addition, provincial regulatory authorities should establish ethical guidelines to avoid conflicts of interest and systems to appraise the evaluation work and discipline personnel.
Although the Guiding Opinion does not alter the rights and responsibilities of medical device manufacturers in China, it does have the potential to improve the quality and fairness of regulatory reviews by provincial and municipal authorities. Industry should continue to monitor the implementation of the Guiding Opinion and any new procedures or guidelines that the provinces may put in place.