Newsletter

USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

  • 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

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QT ANALYSIS: UPDATE IN THE CYBERSECURITY REGULATIONS OF MEDICAL DEVICES IN ASIA (CHINA, JAPAN, SINGAPORE) — AUGUST/SEPTEMBER 2023

QT ANALYSIS: UPDATE IN THE CYBERSECURITY REGULATIONS OF MEDICAL DEVICES IN ASIA (CHINA, JAPAN, SINGAPORE) — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

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China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

  • 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

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EU: Commission Implementing Regulation (EU) 2022/2346 and 2022/2347 of 1 December 2022 Laying Down Rules for the Application of Regulation (EU) 2017/745 – January/February 2023

EU: Commission Implementing Regulation (EU) 2022/2346 and 2022/2347 of 1 December 2022 Laying Down Rules for the Application of Regulation (EU) 2017/745 – January/February 2023

  • 2023-01-19 05:55:29

Two regulations for medical devices have been implemented in the month of December 2022. One is a common specification for the groups of products without an intended medical purpose, the other are rules regarding reclassification of groups of certain active products without an intended medical purpose.

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