• 2021-03-22 01:22:59

The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

• 2021-02-22 02:35:59

Taiwan FDA has announced a Product Registration Guidance for Artificial Intelligent/Machine Learning based Software Medical Device, or so-called AI/ML-Based SaMD. The guidance provides overall requirements and forethoughts for manufacturers to consider and describe when designing and establishing the products.

• 2020-11-26 10:42:10

AI based SaMD is getting more traction in ASEAN counties, owing to their huge potential to transform healthcare industry. At the same time, local regulatory bodies are getting stricter in the evaluation of these AI based SaMD, for added safety and ensuring smooth performance. In this issue of QT Analysis, we are looking into the requirements for registering and marketing these AI based SaMD in selected ASEAN countries.

• 2020-06-16 08:03:29

NMPA released the Draft Revision of Guidance of Software for Medical Device Registration, which increased the scope of application, while paying more attention to the review of technical documents.

• 2020-02-21 07:17:09

HSA released a draft guidance for software regulation last December 2019. The draft includes detailed explanation of regulation from pre-marketing approval to post market monitoring of software devices. The Singaporean authority would like to ask for stakeholder comments before official implementation

• 2020-05-05 07:10:38

With more and more medical device manufacturers engaging into the AI field, China government has started to draft related guidance document to support these firms in building up feasible regulatory strategic plans for their products employing deep learning technologies.

• 2019-11-15 03:03:19

In order to strengthen the quality control of software medical device products, the State Drug Administration has prepared the "Appendix Independent Software for Medical Device Manufacturing Quality Control Specifications (Draft for Comment)" and solicited public opinions.