Chang-Hong Whitney10.21.06
Since the introduction of the surveillance program, the SFDA and CDR have implemented quality inspection programs for products on the market. Under the CDR’s supervision, inspectors take samples of selected product categories from the manufacturers or distributors to conduct quality testing. The testing relies on the product standard filed during the product registration. Usually products of the same category from all suppliers are targeted at the same time. Results (designated as “pass” or “no pass”) are published quarterly on the SFDA’s Web site (www.sfda.gov.cn) and distributed to healthcare providers.
To further streamline the procedures and requirements for random sampling, the SFDA issued a new draft policy, Medical Equipment Quality Supervision Sampling and Testing Management Method, on Sept. 27, 2006. This regulation stipulates the details of the program, from determination of product category to be inspected to evaluation and reporting of final inspection results.
The policy notes that SFDA and the regional FDA offices can conduct separate inspections. The SFDA’s inspection will focus on evaluating the general quality condition of a particular product category, while the provincial offices focus on product quality for surveillance purposes. However, a manufacturer should only be inspected once a year by either agency for one category of products.
The product categories to be inspected are determined by several factors: the potential risks of the products to patients, reports of quality problems from the healthcare community, products that failed previous quality inspections and devices that are considered high risk and under aggressive control (mainly Class III and invasive products).
This policy designates the National Institute of China for Pharmaceutical and Biological Products to formulate product testing protocol, which includes sampling scope, method, sample quantity, testing standard, test items and evaluation principles. At the end of testing, the manufacturer has the opportunity to review the test results and request re-testing if it does not agree with the result. Re-testing procedure and requirements are specified in this policy.
This draft policy did not specify the timeframe for the testing to be completed or indicate whether the manufacturer can monitor the progress of testing. While it is apparent that the SDFA is using the existing drug surveillance system to manage medical devices, it is a bit worrisome to have drug administration agencies responsible for medical device supervision and inspections. More policies and regulations surely will be published in the near future.