SFDA10-2006 PDF English
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"Regulations of medical device’s instructions, labels and packaging marks"
(State Food and Drug Administration Ordinance No. 10)
2006-02-15 [Translator. February 15, 2006]
"Regulations of medical device’s instructions, labels and packaging marks" has been
approved on June 18, 2004 by the Works Council of the State Food and Drug Administration,
and is hereby announced. This Regulations comes into force from the date of publication.
Secretary. Zheng Xiaoyu
July 8, 2004
Regulations of medical device’s instructions, labels and packaging marks
Article 1 In order to regulate medical device’s instructions, labels and packaging marks; to
ensure the usage safety of medical device; and in accordance with "Supervisions and
Regulations of medical device", this Regulations is formulated.
Article 2 All medical devices which are sold and used in the territory of the People's Republic
of China shall attach instructions, labels and packaging marks, according to this Regulations’
requirements. According to the provisions of the State Food and Drug Administration,
easy-to-use products may omit 1 or 2 items of 3 items - instructions, labels and packaging
marks, according to the provisions.
Article 3 Medical device’s users shall use the medical device in accordance with the
instructions.
Article 4 Medical device’s instructions refer to those documents which are provided by the
manufacturer and attached to the product; include product safety, effective and basic
information; and are used for guidance for proper installation, commissioning, operation,
use, maintenance and care.
Medical device’s labels refer to those text, graphics and symbols attached onto the medical
device or packaging, and used for identifying the product’s characteristics.
Medical device’s packaging marks refer to the text, graphics and symbols which are marked
on the package and reflecting the main technical characteristics of the medical device.
Article 5 Contents of medical device’s instructions, labels and packaging marks shall be true,
complete, accurate and scientific; and be consistent with the product characteristics.
Contents of medical device’s labels and packaging marks shall be consistent with the
contents of the relevant instructions.
Article 6 The text of medical device’s instructions, labels and packaging marks must use
Chinese; other languages may be added. Use of Chinese shall comply with the national
common specifications of the language.
The text, symbols, graphics, tables, figures, photographs and pictures of medical device’s
instructions, labels and packaging marks shall be accurate, clear and standardized.
Article 7 Medical device’s instructions shall meet the relevant requirements of national
standards or industry standards, generally it shall include the following contents.
(1) Product name, model and type;
(2) Manufacturer’s company name, registered address, production address, contact
information and the organization of after-sale-service;
(3) Certificate number of "Medical device’s manufacturing enterprise permit license" (except
for the class 1 medical device), registration certificate number of medical device;
(4) Product standard number;
(5) Product performance, the main structure and applicable scope;
(6) Contraindications, precautions and other contents requiring warning or caution;
(7) Contents’ explanation of the graphics, symbols and abbreviations etc. which are used by
the medical device’s labels;
(8) Installation and instructions or icons;
(9) Product maintenance and care methods; special storage conditions and methods;
(10) For product with time-limited use, it shall indicate the expiry date;
(11) Other contents specified by the product standards to be indicated in instructions.
Article 8 Medical device’s labels and packaging marks shall generally include following
contents.
(1) Product name, model and type;
(2) Manufacturer’s company name, registered address, production address and contact
information;
(3) Registration certificate number of the medical device;
(4) Product standard number;
(5) Production date or batch (serial) number;
(6) Power connection’s conditions, the input power;
(7) For product with time-limited use, it shall indicate the expiry date;
(8) Based on product characteristics, it shall indicate graphics, symbols and other related
contents.
Article 9 Medical device’s instructions, labels and packaging marks must not have following
contents.
(1) Contain such expressions "the best effect", "guaranteed cure", "sure-cure", " complete
instructions mainly include.
(1) Possible side effects of using the product;
(2) When accident occurs during the proper using of the product, the protective measures to
the operators and users; and the emergency and corrective measures which shall be
adopted;
(3) One-time-use product shall be marked with "one time use" words or symbols;
(4) Sterilized product shall indicate sterilization; marked with "sterilized" words or symbols;
and indicate the treatment method after the sterile packaging is damaged;
(5) If the product requires disinfection or sterilization before it is used, disinfection or
sterilization methods shall be explained;
(6) When the product needs to be installed or coordinately operated with other products, it
shall indicate the requirements for coordination use;
(7) In the course of usage, the possible mutual interference and potential dangers with other
products;
(8) If the product needs to be treated after used, it shall indicate the appropriate treatment
method;
(9) According to the product characteristics, other matters which shall prompt the operator
and user to pay attention to.
Article 14 Contents relating to the installation in medical device’s instructions shall be able
to ensure the operator and user to properly install and use; it shall include.
(1) Product installation instructions and technical drawings, wiring diagrams;
(2) The environmental conditions required for proper product installation; and the technical
information to identify whether it is properly installed;
(3) Other special installation requirements.
Article 15 When medical device’s Instructions are applied for registration by the
manufacturer, it shall be submitted to (Food) Drug Administration for review in accordance
with the "Registration management method of medical device"; the submitted contents of
the medical device’s Instructions shall be consistent with other materials of registration and
etc.] within 20 working days; the manufacturer shall handle the requirements in accordance
with the notice.
Article 20 The manufacturer who violates this Regulations with one of the following
behaviors shall be given a warning by the county-level-or-above (Food) Drug Administration;
shall be ordered to correct in limited time; and shall be recorded into the corporate
governance files of the manufacturer.
(1) Unauthorizedly change the contents of instructions which have been registered, audited
and filed;
(2) The labels and packaging marks of marketing products are contrary to the contents of
instructions which have been registered, audited and filed; or are in violation of other
requirements of this Regulations;
(3) Medical device’s product name or brand name is in violation of this Regulations;
(4) Marketing product fails to attach the instructions, labels and packaging marks per
requirements of provisions; easy-to-use product may be excepted if there is applicable
provision by State Food and Drug Administration [Translator. Please refer Article 2].
Article 21 If the medical device’s manufacturer unauthorizedly increases the product scope
or product indications in the instructions of the medical device, county-level-or-above (Food)
Drug Administration shall punish the manufacturer in accordance with the 35th provision of
"Supervision and regulation of medical device" – the situation of without obtaining a
registration certificate of medical device.
Article 22 The State Food and Drug Administration shall be responsible to interpret this
Regulations.
Article 23 This Regulations shall take into effect since the announcement of the date. The
"Regulations of medial device’s Instructions" released by State Food and Drug Administration
on January 4, 2002 shall be simultaneously abolished.
[Original Chinese Text]
2006-02-15
局长. 郑筱萸
二○○四年七月八日
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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