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Medical Parkland K.K. is a MAH holder and your partner in Japan.

Marketing Authorization Holder (MAH)

・Market Update

Market Update

・ The third largest medical market in the world, Japan presents many

opportunities for foreign medical and device companies

・ Only local companies with a Marketing Authorization Holder or

Designated Marketing Authorization Holder (MAH/DMAH) license are

legally allowed to import and market medical products in Japan

・ A foreign company has three different options to register and market

their products in Japan

1. Set up their own subsidiary in Japan and register it as a MAH

2. Signing up a Japanese distributor who registers your products in

Japan and acts as your MAH/DMAH

3. Have Medical Parkland act as your MAH in Japan and cater

to your needs.

4. Have an independent third party register your products in

Japan (under the name of the customer company) and act

as your DMAH (only possible for medical devices).

・Requirements and Opportunities

The Japanese MAH requirements are strict, much more so than for example

an European Authorized Representative or US Agent.

・ The MAH must be based in Japan, formally licensed by the

prefectural (regional) government, and employ qualified

persons, i.e. a General Manager (Pharmacist), a Quality Manager

and a Safety Manager.

・ MAHs must also implement a quality management system based

on MHLW Ordinance No. 169 (Japan QMS Regulation and Good

Vigilance Practices (GVP).

Foreign Special Approval System (FSAS) and DMAH

・ Japanese authorities allow foreign medical device manufacturer

to register their product under their name, instead of the MAH’s

name, i.e. foreign manufacturer can be a MAH, and they must appoint

a Designated Marketing Authorization Holders (DMAH) who will take

regulatory responsibility for activities outlined in the Japan QMS and

GVP Regulations.

Services

・Our Services

+ MAH / DMAH for product licensing

+ Product license

+ Importer (MAH / DMAH)

+ Distributor

Additional services

+ Storage service for your medical device and pharmaceutical product.

+ Translation service for your manuals and marketing material.

+ Technical service for your device. Training for dealer, installation.

+ Sales support. This includes searching for suitable dealer for your medical device. Contacting these dealer and negotiate the sales condition according to your wishes.

+ Marketing support. Including market research, market overview, price finding for your medical device. Sales presentation.

News

May 1st, 2022: Succession and sales transfer of two products from Nippon Boehringer Ingelheim Co., Ltd.

(CATAPRES / PERSANTIN)

Team

Henry de La Trobe

Chief Executive Officer, Founder

Henry de La Trobe has a breadth of experience as CEO and CFO of different major companies in Japan and abroad before setting up Meta Park Inc. with a Japanese partner in Tokyo in 2002.

Takanori Ikeda, R.Ph.

Member of the Board

General Marketing Compliance Officer

Board of Director, General marketing Compliance Officer, Head of Regulatory Affairs & Quality Assurance Division.

Mr. Ikeda has more than 35 years of experience in pharmaceutical companies and universities in Japan and abroad, where he has served as Vice President, responsible for R&D, Regulatory affairs, Quality assurance, Business development and Marketing.

He has a wide range of practical knowledge of Pharmaceutical industries, organizational management, including M&A, International business, as well as the establishment of companies, and has experience in improving, blossoming, and developing highly compliant organizations as a rainmaker who makes the impossible possible, so to speak.

He is a graduate of Tokyo University of Pharmacy and Pharmaceutical Sciences and joined Medical Parkland in 2021 as a Board of Director, General marketing Compliance Officer, Head of Regulatory Affairs & Quality Assurance Division.

Yoshihiro Tanaka

COO Member of the Board

After working for a European trading company and a US chemical company, Tanaka was in charge of a European pharmaceutical additive manufacturer in Japan for 25 years.

Tanaka has extensive business experience in the pharmaceutical division of pharmaceutical companies.

Working as the representative director of the Japanese corporation, he understands to keep the head office informed about the peculiarities of the Japanese market, develop and organize the distribution network within this market. He also sponsors a symposium related to pharmaceutical products and contributes to the development of pharmaceutical technology.

Participated as a director from the beginning of Medical Parkland Co., Ltd.

Motohiro Kawai, R.Ph.

Quality Assurance Manager

Kawai has been involved for many years in quality and manufacturing control in the pharmaceutical manufacturing and sales industry.

Taking advantage of this experience, he will provide high quality and safe products for Medical Parkland.

Sayumi Naito

Safety Manager

Naito has been involved in pharmacovigilance-related work for many years at a medical information and pharmaceutical foundation.

As a safety management officer, she will strive to ensure the proper use and safety of pharmaceuticals.

Disclaimer

The information contained in this website is for general information purposes only. The information is provided by [MEDICAL PARKLAND K.K.] and while we endeavour to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk. In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website. Through this website you are able to link to other websites which are not under the control of [MEDICAL PARKLAND K.K.]. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.Every effort is made to keep the website up and running smoothly. However, [MEDICAL PARKLAND K.K.] takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.

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