Items to be included in product standards
Posted: May 2020, 3
This is Nojiri from Support Administrative Scrivener Corporation.
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Today, I would like to introduce the items that should be included in product standards documents for medical devices.
Matters to be stated (from Article 6 (5) of Article-by-Article Explanation)
Item | Key Points |
a. Product group, general name, and brand name of medical devices related to the product (including the model number if it has a model number) | |
Lee.The manufacturing and marketing approval (certification) date and manufacturing and marketing approval (certification) number of the medical device, etc. related to the product (in the case of products that do not require manufacturing and marketing approval and manufacturing and marketing certification, the year of manufacturing and sales notification) time) | |
Cormorant.Item specifications | |
Eh.How to operate or use | |
Oh.Product design, drawings and specifications or ingredients and quantities | |
Mosquitoes.Manufacturing methods and manufacturing procedures (including matters related to equipment, instruments and devices used in manufacturing, and the working environment) | |
Ki.If importing, the name of the country of import, the main country of sale of the imported medical devices, etc., and the name of the product. | |
Click.Matters regarding labeling and packaging | |
ケ.Testing and inspection methods for products, manufacturing substances, component parts, etc. specified in the manufacturing and marketing approval (certificate) | |
Co.In cases where stricter standards and more accurate test and inspection methods are used than those in | |
Service.Standards and tests and inspections that are voluntarily established as necessary for quality control among products, manufacturing substances, components, etc. that are not specified in the manufacturing and sales approval (certification) document. | |
C. When testing and inspecting products, manufacturing substances, component parts, etc. using external testing and inspection institutions, etc., the test and inspection items performed using these institutions, their standards, and testing and inspection methods. | |
vinegar. Storage methods, storage conditions, and shelf life or expiry date of products, manufacturing substances, component parts, etc. (including the results of stability tests that are the basis for the shelf life or expiration date) | |
C. Procedures for determining whether or not it can be shipped from the facility and whether it can be shipped to the market | |
So. Methods and procedures for transporting products | |
Ta. Product repair procedures, storage methods and shelf life of components used in repairs | |
blood. Matters related to installation work and ancillary service work | |
tsu. For sterilized products, matters related to sterilization (must be described based on the results of process validation) | |
Te. Documents showing the details of the agreement between the marketing authorization holder and the facility or office (including the agreement prescribed in Article 72-2, Paragraph 1) (e.g., a copy of the contract signed for the agreement) | |
to. Interrelationships between manufacturers, related facilities, and registered manufacturing sites in terms of quality control supervision system |
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Although I have written it briefly above, in practice it is often difficult to judge how to write it.
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