Maintaining the ability to change distributors, or efficiently sell directly to multiple distributors, is critical to a successful strategy in the complex Japanese market. Applications for medical device registration through the Pharmaceuticals and Medical Devices Agency (PMDA) must be submitted and the license must be held by a properly licensed local agent, the Market Authorization Holder.
Asia Actual is a full-service provider of medical device license-holder services in Japan, specializing in working with regional distributors. Contracting with Asia Actual as an independent license holder allows you to:
Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
Increase transfer pricing (as distributors are not investing in registration costs)
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
A unique aspect of the regulatory process in Japan is the requirement for foreign manufacturers to appoint a Packaging Manufacturer with responsibilities to receive imported medical devices, affix Japanese labeling and clear goods through customs. The Packaging Manufacturer is listed in the registration documentation and can be changed only with a partial amendment to the registration certificate. The Packaging Manufacturer designation can be performed by a qualified distributor, subsidiary office, or independent third party provider. As your Independent License Holder, Asia Actual can provide seamless integration of Market Authorization Holder and Packaging Manufacturing responsibilities.
Contact Asia Actual to see if the Japan Independent License Holding service is right for your business.