Timely support for consultations in Japanese! We are currently accepting MDR applications within Japan.
Medical devices for the European market are required to comply with the MDR (EU Regulation 2017/745) instead of the old MDD (EU Directive 93/42/EEC) as of May 26, 2021. Except for low-risk Class I devices, certification by a Notified Body (N.B.) is mandatory for Class Is, Im, Ir, Class IIa, IIb, and Class III medical devices. Our company acts as the Japanese contact point for the DQS Group, providing services for medical device certification based on Japan's Medical Device and In-Vitro Diagnostic Medical Device Act, as well as serving as the Japanese contact for DQS Medizinprodukte, the N.B. for MDR. Please feel free to consult us for more details. 【What DQS Japan Can Do for You】 ■ Provide bridging services between Japanese medical device manufacturers and DQS Medizinprodukte ■ Secure MDR auditors and Regulatory Affairs Managers residing in Japan, ensuring timely responses to inquiries in Japanese *For more details, please refer to the related links or feel free to contact us.
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**About MDR** **Certification Period for MDR** If your technical documentation is complete and your QMS system is in place, certification can be issued in about one year. The details depend on the class of the medical device and the level of preparedness of the certification system, so please contact us first. **Cost of MDR Certification** The cost of MDR certification varies significantly based on factors such as the size of the company (number of employees related to medical devices), the complexity of the processes, organizational structure, the number of products in the portfolio, the risk class of the medical devices, and the number of technical documents. Please contact us first. *For more details, please refer to the related links or feel free to contact us.*
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DQS Japan is a specialized organization with a headquarters in Germany and over 30 years of experience. As a partner to Japanese medical device manufacturers, we provide medical device certification services for both Japan and Europe. In Japan, we operate as a registered certification body, conducting certification for highly controlled medical devices and controlled medical devices. For Europe, we serve as the contact point for DQS Medizinprodukte (DQS Medical Devices), which is a Notified Body under the MDR.
