Specific packaging requirements are as follows:
1, the product should have the following markings: name of the manufacturer unit, product name, specifications, production date, product number, registered product standard number, product registration number.
2, the product packaging should be the following markings: manufacturer's name, address, trademark, specifications, product name, production batch number or date, sterility and expiration date, "single-use" words or graphic symbols.
3, the package should be packaged with the following markings: product name, specifications and the name of the items within the graphic symbols given by the YY0446 species or the corresponding text description indicates that the product is sterile, production batch number or date, expiration date, manufacturer's name and address, product registration number, manufacturer's license number, the implementation of the standard. Packaging should be placed in the inspection certificate, product instructions.
4, the box should have the following markings: manufacturer's name, address product name, specifications, trademarks, date of manufacture or batch number, product registration number or batch number, quantity, volume, quality, sterility and expiration date for a single use, "be careful to put it gently," and other words and symbols should be consistent with the provisions of GB191
5, Labels and certificates of conformity should be the following information: the name of the manufacturer, product name, the original code of the test, the date of inspection, "qualified".
In order to further strengthen the medical device and a variety of labels and packaging labeling management, etc., June 18, 2004 by the State Food and Drug Administration Board of Directors to consider and adopt, since July 8, 2004 shall come into force - "Medical Device Instructions, Labeling and Packaging Labeling Regulations". According to the "medical device instructions and labeling regulations" Article 19 of the provisions of the "medical device instructions and labeling regulations" shall come into force on October 1, 2014. published on July 8, 2004, "medical device instructions, labels and packaging marking regulations" (the former State Food and Drug Administration Decree No. 10) shall be repealed at the same time.
State Drug Administration-State Food and Drug Administration Decree No. 6 15 years of medical device specification model
I. Product name, model, specifications; (according to the standard)
II. Manufacturer's name, registered address, production address, contact information and after-sales service units;
III, Medical Device Manufacturer's License" number (except for Class I medical devices), medical device registration certificate number;
Four, the product standard number;
Five, the product's performance, the main structure, the scope of application;
Six, contraindications, precautions, and other need to warn or suggest the content; precautions, warnings, and suggestive contents of the main Including:
(a) the use of the product may bring side effects; (b) the correct use of the product in the process of accidents, the operator, the user's protective measures as well as emergency and corrective measures should be taken;
third, single-use products should be indicated "single-use" words or symbols;
three.
(d) sterilized products should indicate the sterilization method, indicate the word "sterilized" or mark, and indicate the sterilization package damage treatment;
(e) need to be disinfected or sterilized prior to use should indicate the method of disinfection or sterilization;
(f) the product needs to be installed or operated with other products together;
(f) the product needs to be used with the other products. (F) the product needs to be installed with other products or coordinated operation, it should be specified with the use of the requirements;
seven) in the process of use, and other products may produce mutual interference and its possible dangers;
(viii) products need to be handled after the use of the corresponding method of treatment should be specified;
(ix) according to the characteristics of the product, the operator should be prompted to the operator, user Attention to other matters.
VII, medical device labeling used in graphics, symbols, abbreviations and other content of the explanation; medical device labeling, packaging identification should generally include the following:
a) product name, model number, specifications;
(b) the name of the manufacturer, registered address, manufacturing address, contact information;
third, the certificate of registration of medical devices number;
IV) product standard number;
V) product production date or batch (edited) number;
VI) power connection conditions, input power;
VII) limited use of the product should be marked expiration date;
VIII) based on the characteristics of the product should be labeled graphs, symbols and other related content
VIII. Installation and Use Instructions or diagrams; the content of the installation should be able to ensure that the operator, the user to install the correct use, including:
(a) product installation instructions and technical drawings, wiring diagrams;
(b) the correct installation of the product must be installed in the environmental conditions and identify whether the correct installation of technical information;
(c) other special installation requirements.
Nine, product maintenance and maintenance methods, special storage conditions, methods;
Ten, the use of products for a limited period of time, the expiration date should be marked;
Eleven, the product standard should be marked in the instruction manual of other content.
Medical device instruction manual content and description Product name Model specification Company name Registered address Production address Contact after-sales service agencies Manufacturer's license No. Registration No. Product standard No. Product performance structure Scope of application Contraindications Precautions, warnings and suggestive instructions Labeling, packaging identification samples Installation instructions Instructions for the use of the maintenance of the method of storage conditions, methods, expiration date Other Content