In December 2014, China's Food and Drug Administration
("CFDA") revised the existing provisional Good
Manufacturing Practices for medical devices ("New GMP"),
and issued the country's first Good Supply Practices for
medical devices ("GSP"). The New GMP rules will become
effective on March 1, 2015, and the GSP rules immediately came into
effect as of December 12, 2014. These rules serve as minimum
standards for the quality management systems of device
manufacturing and distribution in China. They form an important
part of China's new device regulatory regime, which was
substantially transformed since the promulgation of the
Regulation for the Supervision and Administration of Medical
Devices (also known as State Council Order No. 650) on June 1,
The New GMP and GSP rules adopt the following guiding
End-to-End Risk Management
The New GMP rules require legal
manufacturers to manage risks throughout the entire product life
cycle, i.e. from product design and development, manufacturing, and
sales to after-sales services. Likewise, the GSP rules require
distributors to manage risks throughout the entire supply chain,
i.e., from procurement, delivery acceptance, storage, sales, and
transportation to after-sales services. The design and
implementation of the quality management system should reflect
products' risk profiles. For example, distributors of Class 3
devices must build an IT infrastructure to enable sound
implementation of the quality management system, whereas
distributors of Class 1 and 2 devices are not subject to the same
The New GMP and GSP rules also introduce several new
requirements to avoid adverse impacts on product quality in each of
the product transfers. Manufacturers and distributors must qualify
and audit their upstream suppliers and enter into quality
agreements with these suppliers. Manufacturers should also promptly
inform users or consumers of any product changes or updates.
The New GMP and GSP rules require
manufacturers and distributors to retain complete documentation
throughout the product life cycle and supply chain to ensure
traceability. The documentation includes records for product design
and development, production records, testing records, purchasing
records, sales records, and after-sale services records. Records
relating to delivery acceptance and sales of implants must be
Detailed Requirements for Workshops and Equipment
The New GMP enhances the standards
for the manufacturing environment, which must be fit for production
and must not adversely affect product quality. Manufacturers must
maintain appropriate production, testing, and warehousing space.
They must fit the workshops with the necessary production, testing,
and measuring equipment based on product attributes and
manufacturing needs. Manufacturers need to follow protocols for the
operation, cleaning, and maintenance of the manufacturing
equipment, which must be evidenced in relevant records.
The CFDA expects all device companies to comply with the New GMP
and GSP rules as long as they intend to sell the products in China.
The CFDA, like its foreign counterparts, plans to exercise its
jurisdiction over foreign legal manufacturers and may arrange
overseas GMP inspections in the future. Companies that plan to
introduce their devices to China are recommended to carefully
review the New GMP and the GSP rules and timely address any
potential discrepancy in their operations.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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