Class II medical devices must be packaged

The specific packaging requirements are as follows:

1. The product should be marked as follows: Name of manufacturer, product name, specifications Model, production date, product number, registered product standard number, product registration number.

2. The product packaging should have the following markings: manufacturer name, factory address, trademark, specifications, product name, production batch number or date, sterility and expiration date, "single use" words or graphic symbols .

3. The box packaging should have the following markings: product name, specifications and the name of the items inside, using the graphic symbols or corresponding text instructions given in YY0446 to indicate product sterility, production batch number or date, Expiration date, manufacturer name and address, product registration certificate number, production enterprise license number, implementation standards. The inspection certificate and product instruction manual should be placed inside the package.

4. The packaging box should be marked with the following: manufacturer name, address, product name, specifications, trademark, date of manufacture or batch number, product registration number or batch number, quantity, volume, quality, sterility and validity period. The use of words and signs such as "handle with care" should comply with the provisions of GB191

5. The label and certificate should have the following information: manufacturer name, product name, original inspection code number, inspection date "passed" words.

In order to further strengthen the management of medical devices and various labels and packaging markings, it was reviewed and approved by the State Food and Drug Administration on June 18, 2004, and came into effect on July 8, 2004. ——"Regulations on the Management of Instructions, Labels and Packaging Markings of Medical Devices". According to the provisions of Article 19 of the "Regulations on the Management of Medical Device Instructions and Labels", the "Regulations on the Management of Medical Device Instructions and Labels" came into effect on October 1, 2014. The "Regulations on the Management of Instructions, Labels and Packaging Markings of Medical Devices" (formerly State Food and Drug Administration Order No. 10) promulgated on July 8, 2004 were abolished at the same time.

State Food and Drug Administration-State Food and Drug Administration Order No. 6 15-year Medical Device Instructions Template

1. Product name, model, specifications; (according to standards)< /p>

2. Name, registered address, production address, contact information and after-sales service unit of the production enterprise;

3. "Medical Device Production Enterprise License" number (except for Class I medical devices) ), medical device registration certificate number;

4. Product standard number;

5. Product performance, main structure, scope of application;

6. Taboos Symptoms, precautions and other content that require warnings or reminders; Relevant precautions, warnings and suggestive contents mainly include:

(1) Possible side effects caused by product use; 2) During the correct use of the product When an accident occurs, the protective measures for operators and users as well as the emergency and corrective measures that should be taken;

3) Disposable products should be marked with the word "disposable" or symbols;

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(4) Sterilized products should indicate the sterilization method, the word "sterilized" or a mark, and the treatment method after the sterilization package is damaged;

( 5) If disinfection or sterilization is required before use, the method of disinfection or sterilization should be stated;

(6) When the product needs to be installed or operated together with other products, the requirements for cooperative use should be noted;< /p>

7) Possible interference with other products during use and possible dangers;

(8) If the product needs to be disposed of after use, the corresponding Treatment methods;

(9) According to the characteristics of the product, other matters that operators and users should be reminded to pay attention to.

7. Explanation of graphics, symbols, abbreviations, etc. used in medical device labels; Medical device labels and packaging markings should generally include the following content:

1) Product name, model, Specifications;

(2) Name, registered address, production address, contact information of the manufacturer;

Three) Medical device registration certificate number;

IV) Product Standard number;

5) Product production date or batch (serial number);

6) Power connection conditions, input power;

7) Limited use Products should be marked with an expiry date;

8) Graphics, symbols and other relevant content that should be marked according to product characteristics

8. Installation and use instructions or illustrations; installation-related content It should be able to ensure that operators and users install and use it correctly, including:

(1) Product installation instructions, technical drawings, and circuit diagrams;

(2) What is necessary for the correct installation of the product Environmental conditions and technical information to identify correct installation;

(3) Other special installation requirements.

9. Product care and maintenance methods, special storage conditions and methods;

10. Products with a limited use period should be marked with an expiration date;

11. Other contents specified in product standards that should be indicated in the instructions.

Medical device instruction manual preparation content and description product name model specification company name registered address production address contact information after-sales service organization production company license number registration certificate number product standard number product performance structure scope of application contraindications precautions, Warning and advisory labels, packaging identification samples, installation instructions, instructions for use, maintenance methods, storage conditions, method expiration dates, other contents