• 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 02:00:00

Qualtech Consulting Corporation is happy to announce that our client Shimadzu Corporation, Japan has obtained provisional authorisation from the Health Sciences Authority (HSA) in Singapore for its Ampdirect 2019-nCoV Detection Kit.

• 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.

• 2021-02-22 02:52:52

The Ministry of Finance has issued Circular No. 112/2020/TT-BTC, which regulates rates of a number of charges and fees to support and remove difficulties for production and business. It also ensures social security, in response to the Covid-19 epidemic, effective from January 1 to June 30,2021.

• 2021-02-22 02:47:33

Recently the FDA has introduced 5 types of medical devices which can be submitted for evaluation using the latest Safety and Performance Based Pathway. With that, official guidance documents on performance criteria for these devices finally have been issued.

• 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.

• 2021-02-22 02:20:12

This newest announcement is regarding the Device Defect or Adverse Event (AE) Report and Field Safety Corrective Action (FSCAs) Report. It targets to increase level of post-marketing surveillance by including the reporting of device defect or adverse event which occurred in foreign countries.

• 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

• 2021-02-22 01:43:21

Masks and respirators, in various denominations. have become essential things in the new norm of life. There are many types of masks and respirators available in the Malaysian market. Thus, Malaysia Device Authority (MDA) published a new guidance document as a reference for stakeholders. This guidance explains of the type of face masks and respirators that are regulated under the Medical Device Regulations 2012 and the pre-requisites they need to fulfil.

• 2021-02-22 01:36:27

The Indonesian Ministry of Health has stated that Vaccine and Pharmaceutical (medical) Storage / Refrigerator products are no longer considered medical devices locally. This is stipulated on an announcement on January 19, 2021. Therefore, Vaccine and Pharmaceutical (medical) Storage / Refrigerator can be freely sold in Indonesia without getting Medical Device Marketing Authorization Certificate from MoH.