State Food and Drug Administration 10th Order
“Administrative Regulation of Medical Device Specification, Label and Packaging Identification” is approved by State Food and Drug Administration on June 18th 2004, which is published right now. The regulation is valid ever since the publishing date.
Director General: XiaoYu Zheng
July 8th 2004
Administrative Regulation of Medical Device Specification, Label and Packaging Identification
Item 1: This regulation is constituted, according to “Administrative Byelaw of Medical Device”, in order to standardize Medical Device Specification, Label and Packaging Identification, and to guarantee safety of use of medical devices.
Item 2: According to this regulation, all the medical devices distributed and used in the territory of People’s Republic of China should be attached with Specification, Label and Packaging Identification. In terms of regulations of State Food and Drug Administration, for simple and easy products, some one or two of the three items (Specification, Label and Packaging Identification) can be omitted, which is corresponding to its regulation.
Item 3: User of medical devices should make use of medical devices in terms of medical device specification.
Item 4: Medical device specification is a technical document, which is produced by the manufacturing corporation and is provided to the user by enclosing in the product. It contains basic information of product safety and effectiveness, and is intended to instruct correct installation, debugging, operation, use, service and maintenance.
Medical device label is affixed to the medical device or the package. It is instruction, graph and symbol which is intended to identify characteristic of product.
Medical device packaging identification is those instruction, graph and symbol, which are indicated in the packaging and are used to reflect main technical characteristic of medical device.
Item 5: Contents of medical device specification, label and packaging identification should be true, intact, accurate and scientific, and should be consistent with product characteristic.
Contents of medical device label and packaging identification should accord with related items of specification.
Item 6: It is required that instruction of medical device specification, label and packaging identification be expressed in Chinese. And other languages can be affixed. Use of Chinese should comply with State General Language Criterion.
Letter, symbol, table, number, photograph, picture used in medical device specification, label and packaging identification should be accurate, legible and standardized.
Item 7: Medical device specification should comply with state criterion or related requirement of vocation criterion. Generally, it should contain the following contents:
(1) Product name, model and specification;
(2) Manufacturing corporation name, registration address, manufacturing address, contact mode and after service unit;
(3) Serial number of “License of Medical Device Manufacturing Corporation” (except I Medical Device), Serial number of Medical Device Registration Certification.
(4) Standard product serial number;
(5) Product performance, main structure, and applicable area;
(6) Contradiction, notice and other contents which require caution or note;
(7) Explanation of graphic, symbol and abbreviation, etc. used in medical device;
(8) Installation Specification and User Specification or exhibit;
(9) Product service and maintenance method, specific storage condition and method;
(10) For products of limited term, validation period should be indicated;
(11) Other contents which are required to indicate in specification by product criterion.
Item 8: Generally, medical device label and packaging identification should contain the following contents:
(1) Product name, model and specification;
(2) Manufacturing corporation name, registration address, manufacturing address, contact mode;
(3) Serial number of Medical Device Registration Certification.
(4) Standard product serial number;
(5) Product manufacturing date, or Batch number (Serial number);
(6) Connect condition of power supply and input power;
(7) For products of limited term, validation period should be indicated;
(8) According to product characteristic, those graphics, symbols and other related contents which should be indicated;
Item 9: Medical device specification, label and packaging identification should never contain the following contents:
(1) Assertions or pledges of efficacy which contain “optimum curative effect”, “pledged cure”, “cure all”, “cure radically”, “effect instantly”, “without side effect completely” ;
(2) Absolute dictions and expressions, such as those containing “the most advanced technique”, “the most scientific”, “the most advanced”, “optimum”;
(3) Indication of cure rate or efficacy rate;
(4) Comparison of efficacy and safety with products of other corporations;
(5) Promised dictions, such as those containing “insured by insurance companies”, “refund in case of inefficacy”;
(6) Using name or figure of any unit or individual as testification or recommendation;
(7) Those expressions which make people feel that they’ve suffered from a certain disease, or which make people mistake that they would suffer a certain disease or aggregate his state without using this medical device ;
(8) Other contents forbidden by law or rules and regulations;
Item 10: Product name of medical device should comply with corresponding State Criterion and Regulation.
Item 11: Product name of medical device should explicitly be indicated in prominent location of specification, label and packaging identification, and should be consistent with the product name in Medical Device Registration Certification.
Item 12: For medical devices with trade name, its trade name can be indicated simultaneously in specification, label and packaging identification. But it should be consistent with the trade name in Medical Device Registration Certification. When product name and trade name are indicated simultaneously, they should be in different rows and can never be indicated in succession. The characters of medical device trade name can never be bigger than twice of the characters of product name.
Absolute dictions which exaggerate or pledge product efficacy, can never be used in the trade name of medical device. And it can never violate provisions of other law or rules and regulations.
Item 13: Notice, caution and suggestive contents in medical device specification should mainly contain the following items:
(1) Possible side effects caused by use of product;
(2) During the correct use of product, in case of unexpected accidents, the protective method for operator and user, and emergency and corrective method which should be adopted.
(3) For disposable products, the characters of “disposable” or symbol should be indicated;
(4) For sterilization product, the sterilization method should be noted. The characters of “sterilization” or symbol should be indicated. And the managing method, when sterilization package is damaged, should also be indicated.
(5) For products, which require disinfection or sterilization before use, disinfection or sterilization method should be indicated;
(6) For products, which require installation or cooperative operation with other products, requirement of cooperative use should be indicated;
(7) Possible mutual interference with other products and possible related risk during use of product;
(8) For products, which requirement treatment, the corresponding treating method should be indicated;
(9) According to product characteristic, other items which require notice of operator and user;
Item 14: Contents concerning installation in medical device specification should guarantee correct installation and use by operator and user. It should contain:
(1) Product installation demonstration, and technical diagram, circuit diagram;
(2) The environmental condition required by correct product installation, and the technical information to distinguish correct installation;
(3) Other specific installation requirements.
Item 15: When Manufacturing Corporation applies medical device registration, in terms of regulations of “Administrative Method of Medical Device Registration”; medical device specification should be submitted to (Food) Drug Administration for checkup. The submitted medical device specification should comply with other applied registration document.
Item 16: Manufacturing Corporation should be responsible for authenticity and integrality of medical device specification.
Item 17: Contents of medical device specification, which is approved by (Food) Drug Administration, can never be modified on its own.
Item 18: If content of specification variation touches upon regulation, which require re-registration of medical device in “Administrative Method of Medical Device Registration”, the situation can never be dealt with as specification variation.
Item 19: When content of registered medical device specification is modified by Manufacturing Corporation, if variation never touches upon product technical change, the manufacturing corporation should submit corresponding document, and the original approved department of medical device registration should be apprised with written notice. The corresponding document should at least contain:
(1) Copy of registered, referenced specification;
(2) Modified, referenced specification;
(3) Demonstration of specification modifying circumstance(including comparison table of modification);
(4) Standard modified document of registered product (merely limited to variation of specification touches upon standard character modification);
(5) Authenticity statement of submitted document.
Ever since the date of receipt of written notice of modification of medical device specification from the Manufacturing Corporation, if the original registration department didn’t send out written notice of dissent within 20 working days, specification modification is valid and it is put into record by the original registration department. If the original registration department sent out written notice within 20 working days, the Manufacturing Corporation should dispose the situation in terms of notice.
Item 20: If violating this regulation, during which one of the following items occurred, it will be warned by country (or above) (Food) Drug Administration, and will be required to make correction within limited term. It will be recorded in the Manufacturing Corporation Administrative Archive.
(1) Modifying registered, referenced specification on its own;
(2) Label, packaging identification of marketed product go against registered, referenced specification, or violate other requirements in this regulation;
(3) Product name or trade name of medical device go against this regulation;
(4) Specification, label, packaging identification aren’t be affixed to marketed product, except simple and easy product and those which are specified specifically by State Food and Drug Administration.
Item 21: If medical device manufacturing corporation adds product applied area or indication on its own, it will be punished by country (or above) (Food) Drug Administration, according to the 35th item in “Administrative Byelaw of Medical Device”. The 35th item is about condition of without Medical Device Registered Certification.
Item 22: State Food and Drug Administration is responsible for explanation of this regulation.
Item 23: The regulation is valid ever since the publishing date. At the same time, “Administrative Regulation of Medical Device Specification” published by State Food and Drug Administration on January 4th 2002 is in valid.
