• 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 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

• 2024-12-16 05:25:54

The FDA has introduced the Safety and Performance-Based Pathway, offering an alternative route for device clearance by focusing on performance criteria rather than direct comparison to a predicate device. This approach simplifies submissions by emphasizing established safety and performance standards, ensuring effectiveness while reducing regulatory complexities.

• 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.

• 2024-11-05 02:46:36

India's MedTech industry is quickly becoming a key player in global healthcare, driven by government initiatives, rising health awareness, and growing medical tourism. The India MedTech 2024 webinar, hosted by Qualtech Consulting, highlighted trends, challenges, and opportunities in the sector, featuring insights from expert Sandeep Shah. While the market, valued at $11-12 billion, still relies heavily on imports, there is a shift toward local manufacturing and innovation in digital health and AI. With growth prospects in domestic production and rural healthcare, the industry is poised to reach $50 billion by 2030.

• 2024-11-04 08:50:30

Thai FDA introduced new guidelines for handling the registration of medical devices under Notified (Class 2 & 3) and Licensed (Class 4) Medical Device. Thai FDA permitted referencing of previously approved dossiers when applying for brand name changes ("Refer") and for the transfer of medical device licenses between medical device establishment ("Transfer"). This move aimed to streamline the regulatory process, reduce redundant dossier reviews, and simplify licensing in Thailand's medical device sector.

• 2024-10-08 05:56:39

Join Qualtech's Webinar on India's Medical Device Market and Regulations

• 2024-10-10 09:41:55

Indonesia is transforming its healthcare system through three major government projects: SIHREN, SOPHI, and INPULS. These initiatives aim to improve healthcare services, enhance access to specialized care, and strengthen the public laboratory system, addressing major diseases like cancer and heart disease. The projects also present significant opportunities for medical device manufacturers and regulatory consultants to align their offerings with Indonesia’s evolving healthcare needs.

• 2024-09-17 06:26:38

Japan's thriving healthcare market, driven by innovation and growth in medical technology, offers unparalleled opportunities for medical device manufacturers. Qualtech Consulting provides expert regulatory and clinical evaluation services to help you navigate this complex landscape and successfully enter the East Asian market.