• 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 05:30:31

Effective July 1, 2023, COVID-19 diagnostic tests for professional use and self-test kits that were previously authorized under the Pandemic Special Access Route (PSAR) should now be registered through full-fledged product registration. In addition, validation requirement documents for each product type for professional use only and self-test kits were also issued by HSA.

• 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.

• 2023-06-28 07:35:36

HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

• 2023-01-19 02:06:31

The Singaporean Health Sciences Authority (HSA) has updated the regulatory guidelines for Laboratory Developed Tests (LDTs) based on the feedback from the stakeholders for the draft that was published for consultation last July 12 - August 12, 2022. The finalized version is coded as GL – 08 R1 with the title of “Regulatory Guidelines for Laboratory Developed Tests (LDTs)”and will be effective on March 1, 2023.

• 2022-08-30 03:46:38

HSA Medical Devices Cluster (MDC) shared a draft guideline for the regulation of Laboratory Developed Tests (LDTs). The regulation’s scope includes laboratories that develop In Vitro Diagnostic (IVD) devices. HSA requests stakeholders to provide comments for further discussion.

• 2022-02-18 09:04:53

Health Sciences Authority (HSA) issued a list of COVID – 19 test kits that are authorized for professional use. These kits have been given authorization under the Pandemic Special Access Route (PSAR) because Professional Use Only (PUO) kits have been designated as “emergency medical devices”.

• 2022-02-18 08:51:05

Health Sciences Authority (HSA) addresses issues about the creation of new Product Owners (PO) by applicants even though there is an existing one. HSA shares the steps in changing the PO ID number via Change Notification. HSA reminds applicants to search first for the existing PO ID before creating a new one.

• 2022-01-26 10:55:53

The Health Sciences Authority (HSA) has published an update on the Regulatory Fees for Health Products. This is to ensure that the evaluated products meet the required standards of quality safety and efficacy. It is also necessary to recover part of the costs for the services rendered to businesses.