Increased Cooperation between Japan, EU, and Canada for Medical Device Regulations

Japan ‘s Ministry of Health, Labor, and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements with the European Commission’s Directorate General Enterprise and Industry and Health Canada. Both these agreements were signed in October 2009.

The MHLW and the PMDA will cooperate with the European Commission to facilitate the sharing of documents and/or information related to ensuring the quality, safety and efficacy, as appropriate, of medical devices. The exchange of information could include but is not limited to:

  • Advanced drafts of pending laws, regulations, guidance documents, procedures and other technical documents available to the individual Participants related to medical devices
  • Post-marketing data and information that could have an impact on public health or information about impending regulatory actions
  • Information on quality defects or product recalls of products known by MHLW or PMDA to have been manufactured or distributed in the EU and vice versa

The information will be kept strictly confidential between the parties. This information exchange will also be extended to quasi-drugs, which are often regulated as cosmetics in the EU.

For Health Canada, parties will share information on therapeutic products.