Administration Regulations for Instruction and Label of Medical Device Interpretation

Medical device instruction refers to the technical document, which cover the basic information of product’s safety and effectiveness, to give the guidance of installation, debugging, operation, and maintenance. Instruction is formulated by medical device register or record, and offer to the user with product. The instruction compilation is the important part of medical device registration/ medical device record.

What are the requirements of medical device instruction and label?
Medical device instruction and label shall comply with the related requirements of Administration Regulation for Instruction and Label of Medical Device.

What is the main content of medical device?
Medical device content shall contain the following according to Administration Regulation for Instruction and Label of Medical Device.

Product name, specification, and model;( Naming Rules for Medical Device Generic Name)
Register/Record name, address, contact information and after-sale service unit. For imported medical device, the instruction and label also shall include the name and address of agent;
Manufacturer’s name, address, production address, contact information and production certificate No./Production record No.. If the product is entrusted other manufacturers to produce, the instruction and label also shall include the name, address, production address, production certificate No./Production record No. of entrusted manufacturer.
Medical device registration certificate No./ record No..
Number of medical device product technical requirements;
Product performance, main structure and composition, and application scope;
Contraindication, precautions, warnings;
Installation and use instructions;
Product maintenance method, storage and transportation conditions;
Date of manufacture, service time or expiration data;
Accessories list, which include accessories, replacement cycle and method of cusumable;
Explanation of graphics, symbols, and abbreviations of medical device;
Revised date of medical device instruction;
Other content which shall be marked.

For reusable medical device, the processes shall be made clear in the instruction, including cleaning, disinfection, packaging and sterilization methods, frequency and other limit.

What is the main content of matters needing attention, precautions and warnings?

The content of matters needing attention shall contain the following according to Administration Regulation for Instruction and Label of Medical Device.

Product user;
Potential hazards and use restrictions;
Safeguard procedures and corrective action while malfunction;
Monitoring, assessment and control measures;
If the product is disposable, it shall be marked “Disposable” words or symbols; if the product is sterile, shall indicate the sterilization method and handling method after the packaging is damaged.
If the product is used with other medical device, shall indicate the basic requirements, use method and precaution;
Mutual interference produced by working with other medical device and hazards.
Adverse event, or the material which can induce side effect;
If the product need to dispose after using, shall indicate the disposing methods;
Shall indicate the precaution for operator and user according to product feature;

Following contents are forbidden in the instructions and labels:

Functional or effective asserts or assurances , such as 'The best therapeutic effectiveness","guarantee to cure","cure all diseases","cure once and for all","with immediate effect" or "nontoxic and non-side effect at all", etc. ;

Absolute words or expression, such as "the highest technology", "the most scientific", "the most advanced", "the best", etc. ;

Descriptions of cure rate or effective rate;
Comparisons of effectiveness and safety with products of other enterprises.
Promissory descriptions like "secured by insurance company" or "refund for no effect";
Using name or image of any entity or person as demonstration or recommendation;
Misleading description to make people feel that they are suffering from some diseases, or make people misunderstand that they will suffer from some diseases or the diseases will be aggravated if not using the medical devices, and other false, exaggerated and misleading content;

Others forbidden by laws or regulations.

If you want to find more English version of Chinese medical device regulation, you can search the China Medical Device Regulation Database (CMDRD) built by CIRS.

Ms. Windy Jin,
Medical Device Legislation Compliance Deportment, CIRS China;
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Email: Windy@cirs-group.com

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