Medical Device And Pharmaceutical Quality Compliance In China

As one of the fastest growing medical markets in the world, China offers great opportunities for sourcing and manufacturing for foreign medical companies. However, due diligence and appropriate quality standards are key factors you should consider when considering the supply or manufacture in China. Excellent quality systems that comply with the FDA and international standards are needed to sell your medical products manufactured in China-West.
Quality assurance of medical devices products in China

  

  The Food and Drug Administration of China (CFDA) issued various application of Good Manufacturing Practice Regulations (GMP) standards for all medical devices, a stricter adverse events and the system, and other new standards of industry recalls. In addition to the CFDA, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also addresses the security registration, certification and inspection of certain medical devices to ensure the quality.

    However, despite the improvement of standards and the implementation of the GMP regulations for medical devices in China, there are still scandals defective products because of bad quality systems. Foreign companies will carry out checks to ensure that their Chinese operations or partners are performing to the standards expected.

Challenges to meet the GMP standards in China

    In some Chinese factories, there is no organized or centralized quality manuals that employees can easily access.

    Accordingly, the quality control in factories may be minimal. Extensive checks can help locate areas that are deficient and update quality systems to meet Western standards.

    There may be poor control of documents and reports of inconsistency in Chinese factories.

    In some plants, if procedures change, the changes are usually not documented. When a device is reported as having failed, some factories do not investigate or report adverse effects. Having audited the plant can also help identify post-market surveillance issues and establish reporting systems for adverse events.

    Even after a plant is GMP compliant and a good quality system for medical devices China is implemented, problems still arise if employees are not invested in the process.

    It is essential that persons employed by maintenance plant maintenance required to ensure an effective quality system. Many do not understand (or care about) the poor quality control of branches and theft of intellectual property. Supplier audit can assist in employee training.

Quality assurance for pharmaceutical products in China

    All Chinese drug makers also require good manufacturing practices (GMP) certification. This includes in vitro diagnostic reagents manufacturers, medical gases and drugs for traditional Chinese medicine (TCM). However, foreign manufacturers should note that Chinese GMP does not match the United States FDA GMP.

    China Food and Drug Administration (CFDA) are generally not conducted physical inspections of drug manufacturing sites located outside of China. However, they have been training Chinese inspectors at foreign standards and practices. The CFDA may begin inspections of overseas plants within a few years.

Experts from China Pacific quality medical Bridge can advise on ensuring that your Chinese suppliers and manufacturing facilities are in compliance with the US FDA and international quality standards, and internal regulatory requirements of your business. In addition, we can perform audits of your Chinese pharmaceutical suppliers and manufacturing facilities in China.