Pharmaceuticals and Medical Devices Agency (PMDA)
Link for RA:
Pharmaceutical and Medical Devices Law
Who can register :
Data to be communicated :
- Ingredients, amount and function
- Manufacturing methods
- Usage and dosage
- Function and efficacy
- Storage methods and shelf life
- Specification and testing methods
- Examine your product and determine which category it belongs to, as requirements and rules differ depending on the product category.
- Conduct ingredient analysis on samples at MHLW-designated testing facilities owned or leased by manufacturers/importers. It entails examining the ingredient list to see if it complies with Japanese cosmetics requirements.
- Obtaining the necessary licences from the appropriate regulatory bodies, such as a Cosmetic Manufacturing License and a Cosmetic Marketing License. The MHLW must first accredit foreign manufacturers as an “Accredited Foreign Manufacturer.”
- Manufacturers must file a cosmetic marketing notification to the same prefecture awarded the cosmetics marketing licence before beginning the import and selling process.
- Cosmetics Import Notification for Manufacture and Sales
- Cosmetics (foreign manufacturer, importer) notification
- By establishing a local subsidiary, an importer can handle the importation and distribution of its products. In this instance, the regional corporation must adhere to special importer restrictions.
- For the import of cosmetics and quasi-drugs into Japan, you need to obtain
- Primary distribution Approval
- Cosmetic Manufacturing License (packaging, labelling, and storage)
Timeframe and fees:
The registration period for additives is one to two years, while the registration period for active components is at least five years.
Cosmetic labels must be written in Japanese and describe ingredients clearly and plainly. Unapproved claims of functioning or efficacy and labelling containing inaccurate or possibly misleading phrases are forbidden.