CFDA Order No. 6 2014
The newly revised Regulations for the Supervision and Administration of Medical
Devices was put into force on June 1, 2014. To support the implementation of the
Regulations, China Food and Drug Administration (CFDA) formulated and revised
Administrative Measures for Medical Device Registration, Administrative Measures
for the Registration of In Vitro Diagnostic Reagents, Administrative Rules for
the Instructions and Labels of Medical Devices, Administrative Measures for the
Supervision of Medical Device Manufacturing, and Administrative Measures for the
Supervision of distribution of Medical Devices. These five Administrative
Measures have been adopted at the executive meeting of CFDA on June 27, 2014,
and was promulgated on July 30, 2014 as CFDA Order No. 4, Order No.5, Order
No.6, Order No.7 and Order No. 8. These Administrative Measures will go into
effect as of October 1, 2014.
Administrative Rules for the Instructions and Labels of Medical Devices
The administrative rules are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices, with a view to standardizing the instructions and labels of medical devices, to guarantee the safe usage of medical devices.
All the medical devices sold and used within the territory of the People’s Republic of China shall be subject to attach instructions and labels in accordance with these administrative rules.
The instructions of medical device refer to the technical documents which are made by the registration applicant or record applicant, and provided to users with the product. It shall cover the basic information of safety and effectiveness for guiding the correct installation, debugging, operation, use, repair and maintenance.
The labels of medical device refer to the text, graphics or symbols which are attached on medical device itself or its packaging to be used for identifying products features, safety warnings and other information.
The content of the instructions and labels shall be scientific, true, complete, accurate, and consistent with the product features.
The content of the instructions and labels shall be consistent with the relevant content of registration or record.
The content of the labels shall be consistent with the relevant content of the instructions.
The descriptions of disease names, professional terms, diagnostic and therapeutic processes and results in the instructions and labels shall adopt the professional terms which are published or standardized nationally, and the metrological units shall comply with the relative national standards.
Symbols or marking colors in the instructions and labels of medical devices shall comply with the relative national standards. If there is no relevant standard, the symbols and marking colors shall be described in the instructions and labels.
The instruction shall be attached in the minimum sales unit of medical device.
The user shall use the medical device according to its instruction.
The name of medical device product shall be the generic name. Generic name should comply with the naming rules for medical devices formulated by the State Food and Drug administration. The name of Class II and Class III medical device products should be consistent with the name of the product in Registration Certificate.
Product name of product shall be clearly marked in prominent position of the instructions and labels.
The instructions and labels of medical device shall be in Chinese and the use of Chinese shall meet the national common language specification. Other languages may be attached to the instructions and labels, but the Chinese statement shall prevail.
The instructions of medical device shall include the following information generally:
Precautions, warnings and suggestive descriptions in the instructions of medical devices mainly include:
Processing procedures of reuse for the reusable devices shall be specified in the instructions which are including cleaning, disinfecting, packaging and sterilizing methods, time limits or others.
The labels of medical device shall include the following information generally:
Following contents are forbidden in the instructions and labels:
The instructions of medical device shall be submitted to the food and drug regulatory authority for review or record when the registration applicant or the record applicant applies for medical device registration or record. The submitted instructions shall be consistent with other registration or record documents.
The contents of medical device instructions which are reviewed and registered by the food and drug regulatory authority shall not be altered without authorization.
In case of any change registration for registered medical device, the applicant shall revise the instructions and labels according to the change document after obtaining the change document by itself.
In case of any change to other contents of the instructions, the review and approval department for medical device registration shall be informed in written and the relevant documents such as the comparison statement on the change of the instructions shall be submitted. The change of the instructions will be effective if there is no disagreement notice sent by the review and approval department for medical device registration within 20 workdays after receiving the written notice.
In case of any change to the content of record information form, product technical requirement, instruction or others of medical device filed, the record applicant shall revise the relevant content of instructions and labels by itself.
If instructions and labels of medical devices are not in compliance with the Provisions, a punishment shall be imposed by the food and drug regulatory authority at the county level and above in accordance with the provisions in Article 67 of the Regulations for the Supervision and Administration of Medical Devices.
These administrative rules shall come into force as of October 1, 2014, and also abolish the administrative rules for the instructions, labels, and packaging marking of medical device issued on July 8, 2004 (the former Order No.10 of State Food and Drug Administration).