• 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The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices.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.

• 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

• 2024-07-30 03:14:40

The Medical Device Authority (MDA) enforced the policy of medical devices imported from or exported to countries without diplomatic relations with Malaysia that are subject to trade restrictions. This policy was approved during the MDA Member Meeting No. 1/2024 and has been effective since April 26, 2024, under Circular Letter No. 1/2024.

• 2024-06-20 06:31:57

Australia is advancing in 3D-printed medical devices, demonstrating the technology's potential in healthcare. The market, valued at $36 million in 2022, is projected to reach $132 million by 2030, driven by applications in pre-operative planning, education, orthodontics, bioprinting, and customized prosthetics and implants. These innovations enhance patient outcomes and surgical accuracy, with significant growth expected in the Asia-Pacific region.