As one of the world’s fastest-growing medical markets, China offers great sourcing and manufacturing opportunities for foreign medical companies. However, due diligence and appropriate quality standards are key factors that you must take into account when you consider sourcing or manufacturing in China. Excellent quality systems that comply with the China Food and Drug Administration (CFDA), U.S. FDA, and international standards are often needed in order to sell your China-manufactured medical products in the West.
In April 2020, the NMPA announced its newly implemented random inspection regimens on the manufacturing process, distribution, and management of medical devices marketed in China. Under the new regulation, the NMPA and its regional branches’ random inspections will take place in the first quarter of each year. The heavily targeted medical devices are the ones considered high-risk and of questionable quality. Foreign medical device manufacturers are required to designate a local representative based in China to cooperate with the health authorities’ random inspections of its products.
Pacific Bridge Medical’s China quality control/quality assurance consultants can advise you on ensuring that your Chinese suppliers and manufacturing facilities comply with the appropriate quality standards, as well as your company’s internal regulatory requirements. In addition, we can perform on-site audits of your Chinese medical device and pharmaceutical suppliers’ manufacturing facilities.
CHINA QUALITY CONTROL/QUALITY ASSURANCE FOR MEDICAL DEVICES
- The CFDA has issued various regulations to strengthen management and organization at medical device manufacturing sites. This includes implementing Good Manufacturing Practice (GMP) standards for all medical devices, a more stringent adverse events and recalls system, additional on-site inspections, and other new industry standards. In addition to the CFDA, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also carries out safety, certification, and inspection of certain medical devices to ensure adherence to quality standards.
- However, despite the improving standards and implementation of GMP regulations for medical devices in China, there are still many scandals regarding defective products due to poor quality systems. Foreign companies will need to conduct audits in order to ensure that their Chinese operations or partners are performing according to expected standards.
- There are two types of on-site audits that are required in China: a one-time quality management system (QMS) audit for registration that domestic and foreign manufacturers must complete, and a GMP audit for a manufacturing license after registration that local manufacturers must complete annually. Requirements for these audits include an on-site audit checklist as well as multiple company meetings.
CHINA QUALITY CONTROL/QUALITY ASSURANCE FOR PHARMACEUTICALS
- All Chinese drug manufacturers also require Good Manufacturing Practice (GMP) certification. This includes manufacturers of IVD reagents, medicinal gases, and drugs. However, foreign manufacturers should note that Chinese GMP is not equivalent to U.S. FDA GMP.
- The U.S. FDA has been conducting quality inspections in Chinese pharmaceutical manufacturing facilities to ensure that GMP standards are met. Those who refuse inspection or fail to meet these standards are put on the FDA import alert list. Many Chinese drug manufacturing companies have already been placed on this list for violations such as falsifying or deleting data.
CHALLENGES TO MEETING GMP STANDARDS IN CHINA
- In some Chinese factories, there are no organized or centralized quality manuals that employees can readily access.
As a result, quality control in Chinese factories may be minimal. Thorough audits can help locate the areas that are deficient and update the quality systems to meet Western standards.
- There may be poor document control and reporting inconsistency in Chinese factories.
In some factories, if procedures change, the changes are usually not documented. When a device is reported as having failed, some factories do not investigate or report the adverse events. Having the factory audited can help identify post-market surveillance issues and set up systems for reporting adverse events.
- Even after a factory is GMP compliant and a good quality system is set in place, problems will still arise if employees are not invested in the process.
It essential that those employed by the medical device factory upkeep the maintenance required to guarantee an effective quality system. Many do not understand (or care about) the ramifications of poor quality control or intellectual property theft.
- When did China start CFDA/NMPA overseas medical device inspections and what do they include?
In December 2018, the NMPA issued a new regulation for medical device overseas inspections. The Center for Food and Drug inspection (CFDI), a division of the NMPA, is in charge of overseas inspections. Once notified of a foreign inspection, the MAH needs to provide a list of products to be inspected within 20 working days as well as other documents and materials within 40 working days. The overseas inspection includes the manufacturing site, R&D facilities, etc.
Pacific Bridge Medical can help you prepare for a Chinese overseas inspection.
If you have a specific need related to quality issues for medical products in China, contact us today for a free consultation with our China quality control/quality assurance experts.
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