Provisions on the Administration of Instructions for Use and Labels of Medical Devices

(CFDA Decree No. 6)

Issued on July 30, 2014

China Food and Drug Administration Decree

No. 6

The Provisions on the Administration of Instructions for Use and Labels of Medical Devices have been examined and passed on the CFDA General Meeting held on June 27, 2014 and now is for publication. The Provisions shall come into effect as of October 1, 2014.

General Director: Zhang Yong

July 30, 2014

Provisions on the Administration of

Instructions for Use and Labels of Medical Devices

Article 1. These Provisions are established in accordance with the Regulation on Supervision and

Administration of Medical Devices for the purpose of regulating the instructions for use and labels of medical devices, and ensuring the safe use of medical devices. Article 2. Medical devices sold or used within the territory of the People's Republic of China shall be

accompanied by instructions for use and labels according to these Provisions. Article 3. Medical device instructions for use is a technical document prepared by registration

applicant or filing registrant and provided to user along with the product, which covers basic information of product's safety and effectiveness and is used as guidance for correct installation, commissioning, operation, use, maintenance and care of the medical device.

Medical device labels refer to text descriptions, graphics and symbols attached to the medical device or its packaging for identification of product features and providing safety warnings.

Article 4. Contents of instructions for use and labels of medical devices shall be scientific, true,

complete and accurate, and consistent with the product features.

Contents of instructions for use and labels of medical devices shall be consistent with the contents that have been registered or filed.

Contents of medical device labels shall be consistent with contents of the instructions for use.

Article 5. Instructions for use and labels of medical devices shall adopt and use nationwide universal

and standard technical terminology and measurement units in their descriptions of disease names, specialty terminology, diagnosis and treatment process and results. Article 6. Symbols or color identifications used in the instructions for use and labels of medical

devices shall be in conformity with requirements of applicable national standards. Symbols or color identifications not included in existing standards shall be clearly described in the instructions for use. Article 7. The minimum sales unit of medical devices shall be accompanied by the instructions for

use.

Users of medical devices shall follow the instructions for use when using the medical devices.

Article 8. Generic name shall be used for the medical device product name, which shall be

consistent with the medical device naming rules established by China Food and Drug

Administration. Product name of Class II or Class III medical devices shall be consistent with the product name indicated in the Medical Device Registration Certificate.

Product name shall be clearly indicated at conspicuous position of the instructions for use and labels.

Article 9. Text information of instructions for use and labels shall be in Chinese. The use of Chinese

language shall conform to national uniform language norms. Other languages may be

accompanied in the instructions for use and labels of the medical devices; however the Chinese text shall prevail.

Texts, symbols, tables, numbers, and graphics of the instructions for use and labels of medical devices shall be accurate, clear and standardized.

Article 10.

Instructions for use of medical devices shall generally include the following: (1) Name, model and specification of product;

(2) Name, address, contact details and after-sale service providers of registration applicant or

filed registrant, and name, address and contact information of agent for imported medical devices; (3) Manufacturer's name, address, manufacturing site, contact, production license number or

production filing number; if under contracted production, the entrusted company's name, address, manufacturing site, production license number or production filing number shall be also indicated; (4) The medical device's registration certificate number or filing certificate number; (5) Serial number for the product's technical requirements;

(6) Product performance, primary structural component or composition and indications for use; (7) Contents of contraindications, cautions, warnings and informative messages;

(8) Installation and use instructions or diagrams; medical devices for self-use shall also have

special safety instructions; (9) Product care and maintenance methods, special storage and transportation conditions and

methods; (10) Manufacturing date, service life or expiry date;

(11) Part list, including the replacement cycles and replacement methods for spare parts,

accessories, and consumables; (12) Explanation of graphics, symbols, abbreviations and others used in the labels of medical

devices; (13) Preparation date or amendment date of the instructions for use; (14) Other contents to be indicated.

Article 11. Cautions, warnings and informative messages of instructions for use of medical devices

mainly include:

(1) Population of the product use;

(2) Potential safety hazard and use restrictions;

(3) Protections for operators and users, as well as emergency response and corrective actions

in case of accident during normal use of the medical device; (4) Necessary monitoring, evaluation and control measures;

(5) Single-use products shall be marked with \

products shall indicate sterilization method and handling methods in case of damaged

sterile packaging; products requiring disinfection or sterilization before use shall explain the method of disinfection or sterilization;

(6) For products to be installed or used jointly with other medical devices, information for the

other products such as product requirements, methods of use and points for attention shall be provided; (7) Possible interference with each other and potential hazards during use with other products; (8) Potential adverse events during product use, or ingredients or additives in product

composition that may potentially lead to side effects; (9) Matters requiring attention regarding medical device disposal, and appropriate disposal

methods for products that need to be disposed of after use; (10) Other reminders to operator and users based on product features/characteristics.

Article 12. For reusable medical devices, their instructions for use shall clearly state treatment

procedures for re-use, including methods of cleaning, disinfection, packaging and sterilization and the number of repeated use allowed. Article 13.

Labels of medical devices shall generally include the following: (1) Name, model and specification of product;

(2) Name, address and contact details of registration applicant or filed registrant, and name,

address and contact information of agent for imported medical devices; (3) The medical device's registration certificate number or filing certificate number;

(4) Manufacturer's name, address, manufacturing site, contact, production license number or

production filing number; if under contracted production, the entrusted company's name, address, manufacturing site, production license number or production filing number shall be also indicated; (5) Manufacturing date, service life or expiry date; (6) Power connection conditions, input power;

(7) Graphics, symbols and other relevant contents displayed based on product features; (8) Necessary warnings and precautions;

(9) Special storage and handling conditions or explanation;

(10) For medical devices that may damage or have negative impacts on the environment during

use, their labels shall contain warning signs or precautions in Chinese; (11) For radioactive or radiative medical devices, their labels shall contain warning signs or

precautions in Chinese; If labels of medical devices are unable to present all of above-mentioned information due to restrictions of position or size, they shall at least show product name, model, specification, manufacturing date and service life or expiry date, and clearly state in the labels \instructions for use for more information\

Article 14.

Instructions for use and labels of medical devices shall not contain the following: (1) Affirmation or guarantee for product effectiveness such as “best effectiveness”,

“guaranteed cure”, “guaranteed healing”, “thorough treatment”, “instant effects”, “free of any toxics or side-effects” and etc.;