• 2023-09-28 06:42:53

Qualtech is excited to invite you to an insightful webinar: Asia's Business Frontier: Korea Market Expansion & China Registration Service Updates!

• 2023-09-27 07:05:52

The Japanese MHLW has issued Q&A on Software Cybersecurity that was newly added to the Essential Principle

• 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.

• 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 06:00:06

The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.

• 2023-08-23 05:47:28

The Medical Device Authority (MDA) arranged a conference where they made announcements on the implementation of the BayarNow system, creating an E-Certificate, speeding up the registration system, and establishing a relationship with MITI to help the industry.

• 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 03:58:08

Qualtech hosted a talk by Dr. Huang Wen-Chien on the evolution of minimally invasive lung cancer treatment. The advancements discussed included surgical tools, non-surgical techniques, and video-assistive technology. Qualtech also offers comprehensive Clinical Evaluation Report (CER) services to assist with medical device registration, drawing upon expertise in biomedical engineering and molecular biology to deliver high-quality reports for various regions.

• 2023-07-21 02:38:16

The MDA announced a transition period for the implementation of electronic medical device registration certificates on May 22nd, 2023. This announcement is intended to provide information on the use of Electronic Medical Device Registration certificates, which will be fully implemented on January 1st, 2024, and no more physical medical device registration certificates will be issued by MDA.

• 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.