December 11, 2018

Osaka, Japan- Obtaining market access in the Japanese medical device market may sometimes represent a bit of a challenge for foreign manufacturers, given that appointing a Marketing Authorization Holder (a local representative) is mandatory for all medical devices from class II to class IV. That is to say, for all foreign companies that do not own a subsidiary in Japan of their own. However, Qualtech Japan is now ready to assist you with Designated Marketing Authorization Holder Services (DMAH). Hence, we can provide interested customers with the full spectrum of services required for a smooth access to the Japanese market. Including but not limited to product registration with the Japanese authorities and receiving marketing approval. In this way, manufacturers are able to tap into Japan, which constitutes the second largest medical device market in the world.  

Regulations in Place and the Differences Between a DMAH and a MAH

Under the current regulations, foreign manufacturers who would like to sell their medical devices in Japan are in need of a Marketing Authorized Holder (MAH) or Designated Marketing Authorized Holder (DMAH), respectively. This specific mechanism has been adopted through the Pharmaceutical Affairs Law (PAL) amendment of the year 2005, and was further revised with the Pharmaceutical and Medical Devices Law (PMDL) in 2014. While these laws provide foreign manufacturers with greater freedom - as they are no longer bound to a single importer or distributor - it can simultaneously be guaranteed that Japan’s regulatory authorities can refer to a local Japanese company for any correspondence necessary.

Noticeably similar in name, one could certainly also say that MAHs and DMAHs fulfill similar tasks. Yet, the two terms contain important differences one has to be aware of and shall recognize. While both serve as the Japan-based representatives for the medical device product, using a Designated Marketing Authorized Holder (DMAH) via Qualtech allows for significantly greater freedom on the side of the foreign manufacturers. With the appointment of Qualtech as your DMAH, the foreign manufacturer is still the one who controls the registration of its medical device, represents the applicant, and ultimately becomes the owner of the marketing approval. When using the service of a MAH, on the other hand, this is not the case. Contrary to a DMAH, the MAH will actually be in control of the registration and eventually acquire ownership of the certification.

Responsibilities of a DMAH in Japan

Tasks affiliated with the DMAH and thus included in our service package are, among other things, the handling of requirements for Japan’s quality management systems (QMS), serving as the foreign manufacturer’s representative throughout and after the registration process, and the submission of the product registration application to the Registered Certification Body (RCB) for Class II and partial Class III devices and Pharmaceuticals and Medical Devices Agency (PMDA) for Class III and Class IV. Accordingly, we will be taking care of the application until approval has been received and will facilitate communication with the PMDA during the procedure. Yet another benefit of appointing a DMAH is that it is quite easy to change your DMAH and distributor, while allocating a new MAH will undoubtedly represent itself to be far more burdensome and arduous in comparison.

Flowchart of the DMAH Services and the Steps towards Marketing Approval

Figure 1 Flowchart of the DMAH Services and the Steps towards Marketing Approval


What Qualtech Can Offer

Hence, with our thorough expertise in the Japanese medical device market, Qualtech Japan can offer full support in attaining market access to Japan for foreign manufacturers. In fact, a comprehensive service package is being made available, customized to clients’ individual needs and satisfying the highest standards. Lastly, assigning an independent third party as your DMAH, additionally brings the advantage of being assured that your confidential product information are secure. Therefore, shall the DMAH service be of interest for your business - or in case further questions concerning market access in Japan have arisen - Qualtech Japan will be happy to supply additional information via email or phone call (+81-6-6568-9551).