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Device Authentication Service - List of Manufacturers, Suppliers, Companies and Products

Device Authentication Service Product List

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Total support for medical device certification and testing

Total support for medical device certification and testing

Providing certification required for the manufacturing and sales of medical devices, evaluation and testing related to the safety and quality management of medical devices, and assistance with global certification applications.

We provide total support for our customers in obtaining certifications and evaluating and testing safety and quality, including certification under the Pharmaceuticals and Medical Devices Act for medical devices, various safety assessments, ISO 13485 certification for management systems of manufacturers and distributors, traceability certification for measuring instruments used in medical device manufacturing, and support services for obtaining global certifications for overseas exports. 【Features】 ■ As a registered certification body under the Pharmaceuticals and Medical Devices Act (Registration Number: AH), we conduct certifications for "Highly Controlled Medical Devices" (Class 3) and "Controlled Medical Devices" (Class 2). ■ In safety evaluations of medical devices, we conduct a wide range of product evaluations related to medical devices, including safety testing, Radio Law testing, wireless testing, electromagnetic environment testing, software evaluation, biocompatibility testing, and battery performance testing. ■ We issue valid product evaluation test reports as testing data for compliance with safety standards during certification under the Pharmaceuticals and Medical Devices Act and applications for overseas certifications (test reports can be issued with the ILAC-MRA logo). ■ For home medical devices, in addition to the safety evaluation tests under the Pharmaceuticals and Medical Devices Act mentioned above, we also conduct tests for compliance with technical standards required by the Electrical Appliance and Material Safety Act simultaneously. *For more details, please refer to the PDF materials or feel free to contact us.

  • Public Testing/Laboratory

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DQS Japan【MDR Latest Information】Conditions for Extension of MDD Transition Period

DQS Japan【MDR Latest Information】Conditions for Extension of MDD Transition Period

We will deliver the latest information on MDR. This time's theme is "What are the conditions for the extension of the MDD transition period?"

On March 15, 2023, the European Council passed a proposal by a majority vote to extend the validity period for high-risk devices already certified under the MDD until May 2027, and for medium-risk and low-risk devices until May 2028. The official announcement was published in the EU Official Journal on March 20, 2023. The extension of the deadline is conditional upon companies that have obtained current MDD certification completing their formal MDR applications to the Notified Body (N.B.) by May 26, 2024, and finalizing contracts as stipulated in MDR Annex VII section 4.3 with the N.B. by September 26, 2024. Only legacy devices under the MDD (MDCG 2021 25), meaning devices that were placed on the market after the application date of the MDR (May 26, 2021), are eligible to apply for the extension. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications for the 70% of MDD-certified products that have not yet applied for MDR by 2024. Additionally, even for products already certified under the MDD, obtaining MDR certification will be necessary for design changes, so the resource shortage at the N.B. during the transition period is likely to continue.

  • Quality assurance support systems and services

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Medical device certification service

Medical device certification service

Certification for "designated management medical devices (19 categories)" and "designated in vitro diagnostic drugs" is possible!

Our company provides "Medical Device Certification Services" as a certification body registered with the Ministry of Health, Labour and Welfare for designated management medical devices and designated in vitro diagnostic drugs. We mainly handle items such as anesthesia and respiratory devices, dental equipment, and medical electrical equipment. Please feel free to contact us first. 【Features】 ■ Highly specialized and experienced staff conduct the reviews ■ Rapid and reliable certification through our unique certification management system (Expedited service consultations are also available) ■ Provision of appropriate certification costs and clear services for customers ■ Capable of conducting electrical safety tests, EMC tests, wireless tests, and biocompatibility tests ■ Initial free consultations available upon request *For more details, please download the PDF or feel free to contact us.

  • Other Consulting Services
  • Other contract services

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European Medical Device Regulation (EU) 2017/745 (MDR)

European Medical Device Regulation (EU) 2017/745 (MDR)

Entry into further markets made possible! Approval of medical devices for sale or distribution in the European Economic Area.

As of May 26, 2021, the EU Regulation 2017/745 (MDR) has been established to replace the old EU directive on medical devices (93/42/EEC). In terms of content, the MDR differs significantly from the previous EU directives in many aspects. Among the important innovations are the expansion of the scope of application, the specification of minimum content for the creation and maintenance of technical documentation, and the tightening of requirements for clinical evaluation. Additionally, new classification rules have been introduced, including a new class classification for reusable surgical instruments, as well as devices that include software and nanomaterials. [Changes to Regulation (EU) 2017/745 for Medical Device Manufacturers (Partial)] ■ Expansion of the scope of application ■ Specification of minimum content for the creation and maintenance of technical documentation ■ Tightening of requirements for clinical evaluation ■ Introduction of new management procedures for high-risk medical devices ■ Appointment of a person responsible for regulatory compliance (PRRC) ■ Strengthening of requirements for post-market surveillance of medical devices *For more details, please refer to the related links or feel free to contact us.

  • Quality assurance support systems and services

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[MDR Application Reception] European Medical Device Regulation (EU) 2017/745

[MDR Application Reception] European Medical Device Regulation (EU) 2017/745

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.

  • Quality assurance support systems and services

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How to Access the Japanese Market with Medical Devices <For Foreign Companies>

How to Access the Japanese Market with Medical Devices <For Foreign Companies>

Helping medical device manufacturers enter the Japanese market! Introducing the medical device approval (certification) steps.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) regulates the manufacturing, sales, and distribution of medical devices. Medical device approval (certification) requires steps such as "application" and "QMS conformity assessment." Additionally, all application documents and technical documentation must be prepared in Japanese. The DQS Group can assist manufacturers of medical devices entering the Japanese market by dividing roles, so please feel free to contact us when needed. 【Medical Device Approval Steps (Partial)】 ■ Search for the general name of the medical device for which approval is sought, and examine the approval criteria and the status of existing devices in Japan to consider application methods and identify technical issues. ■ Select the applicant (MAH or D-MAH) and prepare the application. ■ Submit the application for medical device certification. ■ Conduct QMS conformity assessment. *For more details, please refer to the PDF materials or feel free to contact us.

  • Other contract services
  • others

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MDSAP (Medical Device Single Audit Program for Canada, the United States, Brazil, and Australia)

MDSAP (Medical Device Single Audit Program for Canada, the United States, Brazil, and Australia)

To those considering entering the medical device market (Canada, the United States, Brazil, Australia)

To those considering entering the medical device market (Canada, the United States, Brazil, Australia): Introducing MDSAP certification.

  • Other quality control and hygiene measures

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