Decree 6 Regulation On Instructions For Use And Labels Of Medical Devices

Article 1
The Regulation is enacted in accordance with the “Medical Devices Administration &
Management Rules” to standardize the Instructions for Use and labels of medical devices
and ensure the safety of medical device applications.
Article 2
Any medical device for sale and use in People’s Republic of China shall have Instructions
for Use and label in accordance with the requirements of the Regulation.
Article 3
The Instructions for Use of medical devices refer to technical documentations made by
the applicant and provided to users that can include the efficient basic information on
product safety and can be used for guidance for proper installation, test, operation, use,
service, and maintenance.
The labels of medical devices refer to the textual descriptions, graphics, and symbols that
are attached to the body or packaging of medical device products and used to identify the
features of products.
Article 4
The content of medical device IFU and label shall be scientific, real, complete, accurate
and consistent to product properties.
The content of medical device IFU and label shall be consistent with the relevant registered
and filed content.
The content of medical device label shall be consistent with the relevant content of IFU.
Article 5
The disease names, professional terms, and description of diagnosis & treatment processes
and results of Instructions for Use and labels of medical devices shall use special
vocabulary unified issued or promulgated by the nation, and the units of
measurements shall be in line with the regulation of national standards.
Regulation on Instructions for Use and Labels of Medical Devices
Article 6
The content of Instructions for Use and labels of medical devices can be expressed in
the form of symbols, and the symbols or identification colors used shall meet the
regulation of relevant national standards. If there is no related standard, the
symbols and colors shall be described in the attached Instructions for Use of the
medical device.
Article 7
The smallest sales unit of medical device shall be attached by IFU.
The users of medical device shall use the medical device according to IFU