Sincere Co., Ltd. provides comprehensive support for obtaining regulatory approval for medical devices, quasi-drugs and cosmetics, primarily focusing on contact lenses in Japan, from application preparation to distribution management.
Sincere Co., Ltd. is a pioneering company dedicated to facilitating market entry for medical devices and related products in Japan. Leveraging its extensive experience as a manufacturer of medical devices, particularly contact lenses, Sincere provides comprehensive support for Regulatory Affairs and approval applications (RA). In addition, it is also familiar with and can handle not only medical devices such as contact lenses, but also quasi-drugs and cosmetics.
To manufacture and sell medical devices in Japan, companies must obtain approval from the Pharmaceuticals and Medical Devices Agency (PMDA) or a third-party certification body. Sincere offers robust support in preparing application documents, consulting on the establishment of internal systems, and liaising with manufacturing plants to meet approval requirements. The company’s services are backed by ISO 13485 certification, ensuring adherence to international standards specific to medical devices. Sincere's knowledgeable staff provide tailored support to meet diverse client needs.
Additionally, Sincere provides Designated Marketing Authorization Holder (DMAH) services, which are crucial for foreign manufacturers seeking to sell products in Japan without a local business presence. The DMAH services acts as the marketing authorization holder, overseeing manufacturing management, quality control and safety management operations in compliance with Japanese regulations. This service allows foreign companies to efficiently manage their distribution and sales networks in Japan..
Sincere holds several key licences, including licences for the manufacture and sale of medical devices, cosmetics and quasi-drugs, as well as licences for the manufacture of these products. The firm's extensive experience in regulatory processes and importation makes it a valuable partner for companies aiming to navigate Japan’s complex approval process and permits. Through its dedicated support, Sincere helps clients achieve successful Japanese market entry and compliance, ensuring the high standards of product safety and efficacy.
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