OMC Medical
OMC Medical

 Cosmetics Registration in Japan

Regulatory Authority:

Pharmaceuticals and Medical Devices Agency (PMDA)

Link for RA:

https://www.pmda.go.jp/english/index.html

Local regulation:

Pharmaceutical and Medical Devices Law

Who can register :  

  • Importer
  • Distributer

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

Process:

  • 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. 

Additional information:  

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.