Continuing with its efforts to strengthen medical device regulation, on July 19, 2013, the Chinese FDA (CFDA) issued draft Administrative Provisions on Quality Supervision Sampling Inspections for Medical Devices (Draft Provisions) for public comment. The taking and testing of samples from companies or institutions that produce, circulate, or use medical devices is one of the postmarketing supervision and enforcement methods required in the 2001 Regulations on Medical Devices, which form the core of China¨s device regulation system. If enacted, the Draft Provisions will replace the 2006 Administrative Provisions on Medical Device Quality Supervision Sampling Inspections that the CFDA issued on a ＾trial basis.￣ Comments on the Draft Provisions were due by August 5, 2013.
The Draft Provisions define procedures for the postmarket collection of medical device samples and their subsequent laboratory testing. The CFDA will design a national work plan for sampling activities, and the branches of the CFDA at the different levels of local government will organize and implement the sampling work for the areas under their administration. The work plan should pay particular attention to sampling and testing devices that are considered potentially dangerous to human health, are widely used or distributed, have evident quality issues, or are connected with adverse event reports.
First, the Draft Provisions articulate the procedures for collection the samples and define the responsibilities of the inspecting officials to conduct neutral and fair inspections. For example, a minimum of two inspectors must collect the sample and, at that time, present appropriate identifying documentation to avoid fraud. The Draft Provisions also describe the responsibilities of the entities involved in production, marketing, or use (e.g., hospitals) of devices to cooperate with authorities. The Draft Provisions are much more specific regarding the method and costs of the sampling than the 2006 Trial Provisions. Under the Draft Provisions, the inspectors must either pay for the sample or return the sample unharmed, or if neither of those options is possible, then the entity that is ＾using the sample￣ will provide a collection method. If an entity refuses to submit to a sample collection without good cause, then the CFDA may stop their production, marketing, or use activities.
Next, the Draft Provisions set forth the procedures for testing the sample. The accredited testing laboratory must ensure that it tests the sample as requested and in a timely manner. If the company is unsatisfied with the test result, it is entitled to apply for a re-test with a different testing laboratory. This procedure also marks a change from the 2006 Trial Provisions, wherein the company typically applied to the original laboratory for a re-test. The re-testing laboratory¨s report is considered the final report. If the testing detects non-compliance with applicable medical device quality standards, then the local FDA branch must take action to resolve the illegal behavior.
The Draft Provisions are vague as to the details of the appropriate punishments for non-compliant entities, relying on the local branch of the FDA to investigate and enforce against non-compliant products. This vagueness presumably means that punishments will be handled under more general administrative laws or device regulations.
The Draft Provisions, along with the Opinion on Strengthening the System for Monitoring Adverse Events for Medical Devices, which was also recently released for comment, are evidence of China¨s ongoing efforts to strengthen, and in some cases overhaul, its laws and regulations governing its expanding drug and device markets.