In vitro diagnostic reagent science knowledge answer (III)

21. Must in vitro diagnostic reagent products be accompanied by labels and instructions?

Answer: All in vitro diagnostic reagents sold and used in China should be accompanied by instructions and labels.

The text content of the instructions and labels of medical devices shall be in Chinese, and the use of Chinese shall comply with the national standards for spoken and written languages. The instructions and labels of medical devices may be added in other languages, but the Chinese expression shall prevail.

The words, symbols, tables, numbers, figures, etc. in the instructions and labels of medical devices shall be accurate, clear and standard.

22. What is the meaning of the product description and label of the in vitro diagnostic reagent?

Answer: The in vitro diagnostic reagent manual carries important information such as the intended use of the product, test methods, interpretation of test results, precautions, etc. It is an important technical document to guide users to operate correctly, clinicians to accurately understand and reasonably apply test results.

The label of an in vitro diagnostic reagent product refers to the text description, graphics and symbols attached to the in vitro diagnostic reagent or its packaging for identifying product characteristics and indicating information such as safety warnings.

23. What should be included in the instructions for in vitro diagnostic reagents?

Answer: The instructions for in vitro diagnostic reagents contain the following:

[Product name]

[packing specification]]

intended use]

inspection principle]

main component]

Storage conditions and period of validity]

applicable instrument]

sample requirements]

test method]

Positive judgment value or reference interval]

interpretation of test results]

Limitations of Test Methods]

product performance index]

[Note]]

Interpretation of Logo]

[References]]

basic information]

[Medical Device Registration Certificate No./Product Technical Requirements No.] (or [Medical Device Filing Certificate No./Product Technical Requirements No.])

[date of approval and modification of the specification]]

If the above items are not applicable to some products, the instructions can be defaulted.

24. How to read the product specification of in vitro diagnostic reagents?

Answer: The information contained in the product manual of the in vitro diagnostic reagent has been reviewed during the product registration process. The results are supported by data, the operating procedures are verified, and the residual risks of the product are clearly indicated. If the content in the manual is a cited document, the source of the reference document should also be indicated.

It should be noted that the same reagent, different enterprises in the product description of the expression may not be exactly the same, mainly because of the product's own situation, may also be the intended use, research and development work or operation process is different.

Attention should also be paid to the applicable models and supporting reagents of the reagents, which are the basic elements of the detection system and must be within the approved scope, otherwise they are not approved products.

Enterprises and users should not change the original detection system of in vitro diagnostic reagents without authorization.

25. Does the advertisement of in vitro diagnostic reagent products need approval?

Answer: In vitro diagnostic reagents are medical devices, and medical device advertisements should be reviewed and approved by the food and drug supervision and administration department at or above the provincial level; without approval, they shall not be published, broadcast, distributed or posted.

The food and drug supervision and administration department shall not publish advertisements for in vitro diagnostic reagent products that are prohibited from production, sale and use.

26. How to understand the advertising approval number of in vitro diagnostic reagent products?

Answer: Whether the advertisement of the in vitro diagnostic reagent product is false or not, the advertisement should be checked to see if there is a "medical device advertisement approval number" and it is true and accurate. If there is no true and accurate "medical device advertisement approval number", it can be judged as false advertisement.

There are three forms of advertising approval numbers for medical device products:

(1) "X Medical Equipment Review (Vision) No. 0000000000";

(2) "X Medical Equipment Guangshen (Sound) No. 0000000000";

(3) "X Medical Equipment Guangshen (Wen) No. 0000000000".

Among them, "X" represents the abbreviation of each province, autonomous region, and municipality directly under the Central Government; "0" consists of 10 digits, the first 6 represent the year of review, and the last 4 represent the serial number approved by the advertisement; "Shi", "Sheng" and "Wen" "Represent the classification number used in the form of advertising media. For example, Xiang Medical Equipment Guangshen (Wen) No. 2012070023, which means that Hunan Province passed the examination in July 2012, is the 23rd of the medical device advertisement approval number sequence examined and passed by the province (autonomous region, municipality directly under the Central Government) in that year, and is a written advertisement content.

Medical device advertising approval number is valid for 1 year.

27. What circumstances should not appear in advertisements such as the scope of application and efficacy of in vitro diagnostic reagents?

Answer: In vitro diagnostic reagent advertising about the scope of application and efficacy of the content of the publicity should be scientific and accurate, shall not appear the following circumstances:

a. Containing an assertion or warranty of efficacy;

B. a description of efficiency;

c. In the advertisement of medical devices recommend to individuals, take advantage of the weakness of consumers' lack of professional and technical knowledge and experience of medical devices, and use specialized terms or unscientific terms beyond the product registration documents to describe the characteristics or mechanism of action of the product;

D. contains the so-called "research findings", "experimental or data proof" and other aspects that cannot prove its scientific nature;

e. It contains commitment terms such as "safety", "non-toxic side effects", "invalid refund", "no dependence", "insurance company underwriting", etc., and contains absolute or exclusive terms such as "unique", "accurate", "latest technology", "most advanced science", "national products", "filling domestic gaps;

f. Claiming or implying that the in vitro diagnostic reagent is necessary for normal life or treatment of diseases;

g. It contains contents that express or imply that the in vitro diagnostic reagent can cope with the needs of modern stressful life or further studies and examinations, can help improve or enhance performance, can make energy vigorous, enhance competitiveness, can increase, can improve intelligence, etc.

28. What in vitro diagnostic reagent advertisements must not contain to encourage the public to buy?

Answer: In vitro diagnostic reagent advertisements should promote and guide the rational use of in vitro diagnostic reagents, and must not directly or indirectly encourage the public to purchase and use, and must not contain the following content:

a. Unscientific expression or by exaggerating or exaggerating the harm caused by a certain health condition or disease, causing the public to worry and fear about the health condition or the disease they suffer from, or causing the public to misunderstand that they will suffer from a certain disease or aggravate the disease if they do not use the product;

B. "Family essentials" or similar;

C. appraisal, ranking, recommend, designation, selection, award and other comprehensive evaluation content;

D. state that the product is in "hot sale", "snapped up", "trial", etc.

29. Can the advertisement of in vitro diagnostic reagents be used as image and proof by experts, institutions, etc?

Answer: in vitro diagnostic reagent product advertisements shall not contain the content of using the name and image of medical research institutions, academic institutions, medical institutions or experts, doctors and patients as proof; it shall not contain the name, address, contact information, diagnosis and treatment items, diagnosis and treatment methods of medical institutions, as well as the contents of medical services such as free clinic, medical (hotline) consultation and special outpatient service; it must not contain the name and image of military units or military personnel; it must not use military equipment and facilities to engage in in vitro diagnostic reagent advertising; it must not contain public information, public events, or other content related to public interests, such as various disease information, economic The achievements of social development or scientific and technological achievements other than medical science; shall not be published on minor publications and channels, programs, or columns; children shall not be the object of appeal, and in vitro diagnostic reagents shall not be introduced in the name of children.

30. What are the main forms of advertising for in vitro diagnostic reagents that deceive and mislead consumers?

Answer:(1) False information: the products, services or performance advertised by the advertisement do not exist at all, and the purpose is to defraud consumers of money;

(2) false quality: refers to the actual product or service provided, to a large extent, does not meet the quality, standards, or technical standards claimed in the advertisement;

(3) False function (purpose): it means that the product or service provided does not have or does not fully have the function (purpose) claimed in the advertisement, or arbitrarily exaggerates the function (purpose) of the product service and expands its scope of use;

(4) False price: refers to the use of false or misleading price conditions in advertising to induce others to trade with them, such as false price reduction, two sets of prices, hidden prices, etc;

(5) False certification materials: It refers to deliberately providing false certification materials to render the untrue quality and function of its products or services, so as to deceive people. it mainly involves forging inspection or examination approval documents by relevant state administrative departments or authorized units;

(6) False source: refers to the false advertising of the source of the products or services provided (such as the origin, producer, source of raw materials, etc.);

(7) False time: refers to the use of advertisements to make false publicity about the production date, expiration date and other relevant time content of the products provided;

(8) false composition: the use of the lack of professional knowledge of consumers, the composition of the product or the content of the ingredients made false propaganda;

(9) False endorsement: fake and embezzlement of images, movies, sounds and other characteristic images of social celebrities as endorsements;

(10) Other.