• 2024-12-16 08:47:55

This guidance clarifies the regulatory framework for the use of EtO in sterilizing medical devices and in vitro diagnostic medical devices.

• 2024-12-16 08:32:04

Following the Industry Consultation held from 25 January to 10 March 2023 and Sandbox Phase conducted from October 2023 to July 2024, the CSA, in collaboration with MoH, HSA, and Synapse launches the Cybersecurity Labelling Scheme for Medical Device [CLS(MD)] for public applications along with a set of publications as guidelines for the applicants. The program opens for voluntary enrollment on 16 October 2024 as part of Singapore's effort to enhance cybersecurity awareness.

Manufacturers who wish to pursue one of the 4 cybersecurity levels should apply to Cybersecurity Certification Centre (CCC) through GoBusiness Licensing Portal https://www.gobusiness.gov.sg while inquiries can be sent to email: cls_md@csa.gov.sg.

• 2024-12-16 03:51:16

The Ministry of Health promulgated Circular 19/2024/TT-BYT dated October 1st,2024, which issued the list of exported and imported medical devices that have been assigned Harmonized System commodity codes according to the Vietnam Export and Import Goods Classification List.

• 2024-11-04 10:27:21

Starting from 1 January 2025, Local Responsible Persons must submit Medical Device Listing Renewal Applications between 12 weeks and 1 year before the expiry of their listing approval. Applications that fail to reach MDD before the 12-week mark will not be processed.

• 2024-11-04 05:15:38

The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices. It advises manufacturers to use targeted analytical techniques to identify and quantify chemical constituents, focusing on both device material composition and potential patient exposure.

• 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

• 2024-09-17 06:13:22

The Therapeutic Goods Administration (TGA) plays a critical role in ensuring the safety and efficacy of medical devices in Australia. In line with its mandate, the TGA has released a guidance on Essential Principle 13B, to guide manufacturers with medical device products incorporating software.

• 2024-09-17 05:57:50

Australia's TGA has issued two new guidance on software-based medical devices. Sponsors must comply with the new classification rules with the transition period ending by November 1, 2024. Additionally, the TGA clarified which software products are subject to regulation, providing clear guidelines for industry.

• 2024-09-17 05:26:27

The National Medical Products Administration (NMPA) and National Health Commission (NHC) have issued guidelines for the temporary importation of urgently needed medical devices in clinical settings. The regulation streamlines import processes while ensuring compliance with safety standards, allowing medical institutions to quickly access essential, unregistered devices. It aligns with NMPA Orders No. 47 and 48, emphasizing patient safety and timely access to critical medical equipment.

• 2024-09-17 05:23:25

This guidance offers instructions on the clinical evaluation of orphan devices under the MDR.