Registration in Japan - クアルテックジャパンコンサルティング株式会社

医療機器の法規制対応はクアルテックジャパンコンサルティング 

CFDA, TFDA, HSA, MDA, MDCO, PFDA, MOH, Thai FDA, CE mark

〒550-0005 大阪市西区西本町1丁目12-19

TEL&FAX 06-6568-9551

info@qualtech.co.jp

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Japan Registration

Registration in Japan

Qualtech has formed a professional and multidisciplinary team with individuals from a wide range of backgrounds including medical science and engineering. Together we strive to provide high-quality service in device regulatory registration, and owe our success to the combined knowledge and skills that have been built as a team. registration003

Qualtech holds license in several countries around the globe, and has acted as a local representative for countless foreign manufacturers. We have enabled companies to manage their products in conformity with local regulations, and has helped in avoiding confrontations to ensure that products can be delivered smoothly.

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Qualtech is a medical device consulting and clinical trial company that was founded in 2000. Since its establishment, Qualtech has built its company culture on a foundation of integrity, teamwork, and lifelong learning. The multinational team at Qualtech includes individuals from a broad range of backgrounds including medical sciences and engineering. Together we strive to provide high-quality service in regulatory consulting and clinical trial services and owe our success to the combined knowledge and skills that have been built as a team.

Qualtech has acted as a local representative for countless foreign manufacturers. In addition, we have helped bring a large number of advanced devices and products successfully into new markets in Asia by establishing a strong partnership with each client. Qualtech has established branches in Taiwan, China, Singapore, Malaysia, the Philippines, Hong Kong, Indonesia, Japan, and Vietnam. We have built our reputation through providing high quality and efficient solutions and it is our goal to continue to provide excellent local regulatory advice, product registration, and license holding services.

Contact

Thank you for your continued support. If you would like to request any additional information about product registration services, we ask that you kindly provide your contact and product information in the form in the following link. We’ll reply as soon as possible.

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