• News and events
  • 2018
• About LNE/G-MED
  • Brief history
  • Legal status
  • Organization and management
  • Activities
  • G-MED North America
  • Addresses & Contacts
• Services
  • CE marking
  • Certification of Company Management Systems
  • Quality certification of sterilization processes
  • Access to the Canadian market
  • Access to the American market
  • Access to the Taiwanese market
  • Access to the Australia and New Zealand markets
  • Access to the Japanese market
  • Medical equipment :
    CB Scheme certification
  • Product certification
  • Training
• Applying for certification
  • How to obtain certification
  • Receive a detailed proposal
  • Additional information
• Certified companies or bodies
• Recognition and accreditation
• Guides
  • CE Marking : Dealing with changes in medical devices
  • IEC 60601 3rd edition
  • Electromagnetic Compatibility (EMC)
  • Registration medical device in Brazil
  • Japanese Medical Device Approval Process
  • How to change your Notified or Certification Body
  • Presentation of biological evaluation According to ISO 10993-1
• Regulatory information
  • Revisions to the Medical Devices Directives
• Links to key sites
• FAQ

Is your company based in North America?
G-MED NA provides the services you need

Registration medical device in Japan - Free guide

Even though the requirements of the Japanese Pharmaceutical Affairs Law (PAL) have been simplified to help the foreign manufacturers selling their medical devices in Japan, they still remain complex. Therefore, LNE/G-MED publishes a guide to help manufacturers export their products.

This guide describes the different steps to obtain the licenses for manufacturing and marketing the devices.

To freely receive this guide, please fill out the form below. Make sure your email address is valid so we can send you the guide.

* These boxes must be filled in