Manufacturing operation at “DMAH”

  • Obtain PMDA/Notified body approval on your product

  • Quality Inspection
  • Labeling (Legal indication), Attaching of the Package Insert
  • Shipment to your distrubutors
  • GVP operation

  • Inventory management

  • Order management

  • GVP reporting to PMDA

 Experienced licenses We Worked On

Laser surgery equipment, Laser dermatology & cosmetic equipment, Dental laser equipment.
Please ask us whatever you want…

 

Which one do you want to chose? MAH? DMAH?

Marketing Authorization Holder (MAH)
Appointed Designated Marketing Authorization Holder(DMAH)

In orfer to sell a medical product made by a foreigh manufcaurer in Japan. they must first obtain approval as a “foreighn manufcature”. Then, the Japanese “medical device manufactrering and sales business” files a pharmaceutical application with the Pharmaceutical and Medical Devices Agency (PMDA) on behalf of the foreign manufactrer, and obtains approval to sell the product in Japan.

In this case, there are two types of choice A or B.

A : In the case of Marketing Authorization Holder (MAH): Your distirbutor in Japan becomes MAH and has the right to obtain approval as license holder taking all regulatory respnsibilties in Japan. License belongs to your distributor.

 

B : In the case of Designated Marketing Authorization Holder (DMAH): the applicant is a foreign manufcaturer and approvals & license belongs to the foreign manufacturer. This is called a special foreign approval. The foreign manufcaturer has the right to the approval obtained through application withough relying on the distributor. License belongs to the foreign manufacturer. DMAH maintain compliance on the license with Quality Manameget System, GVP operation on behalf of foreign manufacturer.