CFDA released a notice requiring distributors of Class II and III devices to assess their compliance with Medical Device Good Supply Practices (“GSPs”) and other medical device regulations over the course of the last two years. These distributors must also submit a self-assessment with a plan for remediation to their municipal food and drug admiration by July 15, 2016. CFDA used this “self-inspection” approach in 2015 with drugs when it required drug manufacturers to assess their compliance with Good Clinical Practices. That effort resulted in reports of noncompliance and withdrawal of clinical trial applications by some manufacturers, as well as rejection of many manufacturers’ marketing applications by CFDA. Bad records may result in heightened scrutiny by municipal authorities and possibly additional inspections. Failure to report, fabrication or omission of information from reports may result in much more significant penalties, including loss of licensure and even criminal sanctions.
The notice calls for medical device distribution companies to assess their compliance records since June 1, 2014. Their investigation should focus on eight categories of violations:
- procurement from unqualified suppliers and downstream distributors and healthcare institutions;
- failure to comply with device Good Supply Practice requirements;
- fabrication of application documents;
- failure to obtain or extend distribution licenses for Class III devices;
- distribution of unlicensed products (particularly by domestic agents for imported devices);
- distribution of products that fail to meet mandatory standards and technical requirements, or are obsolete or expired;
- failure to transport and store medical devices in accordance with their labels and package inserts; and
- failure to establish and implement the appropriate testing and record keeping system for incoming and outgoing products.
Once the reports are in, the provincial FDAs will conduct targeted inspections of: (1) distributors that are considered to have bad records, (2) distributors of medical devices requiring low temperature and cold storage, and (3) domestic agents for imported medical devices. The provincial FDAs will submit reports to CFDA by September 30, 2016. CFDA will use the results of these reports to conduct its own inspections. The notice also encourages members of the public to report companies’ illegal activities and promises rewards for confirmed violations.