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Search for "Pre-market Approval" related English Translations
43 results found
Most Popular
Lastest Update
Requirements for Management on Whitening Products
Jan 29, 2015
EN
Whitening products are reclassified as special use cosmetics and fall into the category of spot-removing products. From 30 June 2015, the manufacture and import of whitening products without an accompanying special use cosmetic certificate will be banned. This regulation stipulates the requirements for management on whitening products.
Chinese Mainland
Pre-market Approval
Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
Dec 04, 2018
EN
This document is the order for enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraph (4), Article 11 (including as applied mutatis mutandis pursuant to Article 38), Article 28, paragraph (2), Article 30, paragraph (3), Article 43, paragraph (2), Article 67, paragraph (1), Article 77, paragraph (3), Article 78, paragraph (1), Article 80 and Article 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960). Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2016 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.
Japan
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Enforcement Rules of Cosmetic Hygiene and Safety Act
Jul 18, 2019
EN
The Enforcement Rules specify the definition of cosmetic country of origin and manufacturing site and conditions of the claim or advertising violation, etc. and give clear details of the compliance requirements for manufacturer and importer.These Enforcement Rules shall come into force on July 1, 2019, with the exception of Article 3 and Paragraph 2 of Article 4, which shall come into force on July 1, 2021.
Taiwan, China
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Advertising
Regulations Governing Notification of Cosmetic Products
Jul 18, 2019
EN
The Regulations stipulate the documents necessary for cosmetics notification, validity for cosmetics notification and other issues related for cosmetics notification in Taiwan.
Taiwan, China
Pre-market Approval
QB/T 1685-2006 Requirements of Packaging Appearance for Cosmetic Products
Dec 28, 2017
EN
This standard is a revision of QB/T 1685-1993: Requirements of packaging appearance for cosmetic products. Compared with QB/T 1685-1993, this standard made the following main changes: ---Added spray head (including pneumatic, pump) types in packaging category; ---Deleted 3.11 in the former standard; ---Modified visual test method.
Chinese Mainland
Pre-market Approval
Testing
Regulations for Cosmetic Product Information File Management
Jul 19, 2019
EN
The regulation specifies information about how to build product information file(PIF), including qualifications of the manufacturer and importer who can establish the PIF, documents required for PIF, the time PIF should be kept, the qualifications for product safety data signers, etc.
Taiwan, China
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Safety Assessment
Testing
Regulations for Reporting Cosmetics Serious Adverse Effects and Hazards to Hygiene and Safety
Jul 22, 2019
EN
The regulation stipulates the target to notify, the method and content of adverse event notification. If severe adverse events occur or the product is found to be harmful to human health, it shall be notified on the online system established by the central competent authority within 15 days (in an emergency, manufacturers can notify it verbally). The credentials, dossiers or data shall be kept for at least 5 years.
Taiwan, China
Pre-market Approval
Post-market Surveillance
Guidance of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong (EN Version Available)
Mar 26, 2018
EN
This Guidance is applicable to the application for and handling of relevant service concerning the filing management of imported non-special use cosmetics in Pudong New Area of Shanghai.
Chinese Mainland
Pre-market Approval
Pudong Filing
Regulations Governing the Issuance and Management of Cosmetic Certificates
Jul 18, 2019
EN
The regulation specifies the necessary dossiers requirements for 5 types of cosmetic certificates in Taiwan, namely type A cosmetic production and sales certificate, type B cosmetic production and sales certificate, cosmetic manufacturing certificate, imported cosmetic sales certificate and cosmetic good manufacturing certificate.
Taiwan, China
Pre-market Approval
Manufacturer/Importer Regulation
Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics
Jul 19, 2019
EN
The regulation specifies the requirements for the import application of non-licensed specific purpose cosmetics.
Taiwan, China
Pre-market Approval
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