ドイツ品質システム認証 List of News Articles

On March 15, 2023, the European Council passed a proposal by a majority vote to extend the validity period for high-risk devices that have already obtained MDD until May 2027, and for medium and low-risk devices until May 2028. The official announcement was published in the EU Official Journal on March 20, 2023. For the conditions regarding the extension of the MDD transition period, please refer to the downloadable materials. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications to Notified Bodies (N.B.) for products that account for 70% of MDD-acquired products that have not yet applied for MDR by 2024. Additionally, even for products that have already obtained MDD, obtaining MDR will be a requirement for design changes, so the resource shortage at N.B. during the transition period is expected to continue. Therefore, DQS Japan has decided to establish a consultation desk for companies that have obtained MDD but have not yet applied for MDR regarding future actions. Please feel free to contact our representative for inquiries about future actions, including second opinions.

ISMS (ISO 27001) has increasingly become a requirement for bidding conditions in government agencies, where companies that have obtained ISMS/ISO 27001 certification are often presented as a condition. Moreover, this trend is not limited to government agencies; private companies are also steadily adopting it as a bidding requirement. Additionally, ISMS initiatives include practices such as clear desk and clear screen policies, which promote "organization and tidiness." By effectively utilizing these practices, it is possible to organize internal information and improve operational efficiency. The ISMS has been revised to its latest version as of October 2022. DQS is offering a special service for the 2022 version, where, starting from January 2023 (with an undetermined end date), if you change to a new certification or auditing body, we will provide a reasonable special pricing arrangement. Please feel free to consult with us.

On February 16, 2023, the European Parliament passed a proposal by a majority vote to extend the validity period for high-risk devices that have already obtained MDD until May 2027, and for medium-risk and low-risk devices until May 2028. This decision will officially take effect upon publication in the EU Official Journal. The extension of the deadlines is conditional upon companies that currently hold 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. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications for the 70% of products that have not yet applied for MDR, which are currently under MDD. Additionally, even for products that have already obtained MDD, obtaining MDR is a requirement for making design changes, so it is anticipated that resource shortages at the N.B. during the transition period will continue. DQS Japan has decided to establish a consultation desk for companies that have obtained MDD but have not yet applied for MDR regarding future actions. Please feel free to contact our representative for inquiries about future actions or second opinions.

For those considering entry into the medical device markets (Australia, Brazil, Canada, Japan, and the United States), we introduce the MDSAP review. MDSAP is a method that allows medical device manufacturers to undergo a single audit for compliance with standards and regulatory requirements in up to five different medical device markets (Australia, Brazil, Canada, Japan, and the United States). The Medical Device Single Audit Program (MDSAP) is an audit of the quality management system (QMS) of medical device manufacturers, enabling them to meet regulatory requirements across multiple jurisdictions with a single audit. 【Benefits for Customers】 - Access to up to five markets with a single procedure - Includes requirements from Australia, Brazil, Canada, Japan, and the United States - Saves time and resources by consolidating findings from multiple audits - Planned audit content - Cost savings compared to individual audits - Recognized track record in medical device registration, leading to reduced local inspections by participating authorities 【Flow to the MDSAP Certification Process】 Relevant materials are attached.