• 2024-12-16 09:17:34

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

• 2024-03-01 09:11:58

The NMPA decided to establish a technology-centralized unit for the standardization of medical device packaging.

• 2024-01-26 07:14:49

The NMPA has revised the Quality Management Standards for Medical Device Operation. This article summarized the critical points of the revision.

• 2023-10-20 06:59:35

PMDA revised Technical Standards for some of the class III generic devices. The notices were issued on August 31.

• 2023-08-23 06:16:37

Center for Medical Device Standardization Administration NMPA forwarded the notice of the National Electrical Equipment In Medical Practice Standardization Technical Committee on carrying out a survey for the implementation of the GB 9706.224-2021 "Medical Electrical Equipment Part 2-24: Special Requirements for Basic Safety and Basic Performance of Infusion Pumps and Infusion Controllers" and GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance".

• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.

• 2023-07-21 03:04:45

The information regarding the qualified institutes for the testing according to GB 9706.1-2020 and YY 9706.102-2021.

• 2023-04-25 02:06:51

GB 9706.1-2020 <Medical electrical equipment - Part 1: General requirements for basic safety and essential performance > was announced on 9th April 2020 and has been put into effect from 1st May 2023 onwards. The interpretations and relevant information are provided and have been briefly summarized in this article.

• 2023-04-25 01:46:23

The Japanese Industrial Standard of EMC (JIS T0601-1-2) has been amended.