Decree 101 Good Manufacturing Practices On Sterile Medical Devices

CFDA’s Announcement on Issuing Appendix of Sterile
Medical Devices to Good Manufacturing Practice for Medical
Devices ([2015] No.101)
Issued on July 10, 2015
With the view to strengthening supervision and management of medical devices manufacturing, and
standardizing quality management of medical devices manufacturing, China Food and Drug
Administration organized the drafting of Appendix of Sterile Medical Devices to Good Manufacturing
Practice for Medical Devices in accordance with Regulations for the Supervision and Administration of
Medical Devices (State Council Order No.650) and Provisions for the Supervision of Medical Device
Manufacturing (CFDA Order No.7), which is hereby released.
This Appendix is the special requirements of Good Manufacturing Practice for Sterile Medical Devices.
The manufacturing quality management system of sterile medical devices shall meet the requirements
of Good Manufacturing Practice for Medical Devices and this Appendix.
Annex: Appendix of Sterile Medical Devices of Good Manufacturing Practice for Medical Devices
China Food and Drug Administration
July 10, 2015
Decree 101 Good Manufacturing Practices on Sterile
Medical Devices
Part 1 Scope and Principles
1.1 This Appendix includes special requirements of good manufacturing practice for sterile medical
devices.
1.2 During the production of sterile medical devices, the requirements for quality and intended purpose
shall be met, and pollution shall be minimized; cleanliness level of clean room (zone) of sterile medical
devices shall be determined on the basis of product features, manufacturing process, equipment, etc. in
order to protect the medical devices from pollution or to effectively eliminate pollution.
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Part 2 Special Requirements
2.1 Personnel
2.1.1 Personnel working in the clean room (zone) shall be provided with basic knowledge of hygiene
and microbiology, clean operation and other trainings. And guidance or supervision shall be given to any
person who enters clean room (zone) temporarily.
2.1.2 Cleaning requirements for personnel shall be set up and hygiene code shall be formulated for
workers in clean room (zone). Any person who enters clean room (zone) shall wear work cap, respirator,
clean working garment and work shoes, as well as receive purification in accordance with applicable
procedures. Operators who contact products with bare hands shall disinfect their hands at regular
intervals. In addition, type of disinfector shall be changed regularly.
2.1.3 Health requirement for personnel shall be established, and health record shall be formulated.
Personnel who directly contact materials and products shall receive physical examination at least once
every year. Nevertheless, any person suffering infectious or contagious disease shall not engage in
works in which direct contact with products is required.
2.1.4 Clothing requirements for personnel shall be defined, i.e. regulations on clean and sterile working
garment shall be formulated. Working garment and its quality shall match requirement of production
operation and cleanliness level of the operation area; furthermore, its style or wearing mode shall be
suitable for protecting products and personnel. Any fiber or particulate matter shall not fall off from
both clean working garment and sterile working garment; besides, sterile working garment shall be able
to cover hair, beard and feet completely, as well as hold substance falling off from human body.