• 2021-03-22 07:09:05

In Malaysia, Post-Market Surveillance and Vigilance (PMSV) is regulated under the Medical Device Act 2012 (Act 737) and Medical Device (Duties and Obligations of Establishment) Regulations 2019. In this edition of QT Analysis, tag along with us to keep updated on the latest PMSV requirements in Malaysia.

• 2021-03-22 06:57:43

Department of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.

• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.

• 2021-03-22 03:45:47

Thai FDA has announced the official medical device registration guidance for Licensed medical device and Notified medical device and Listing after promptly complete a transition from policy-based classification to risk-based classification of medical devices.

• 2021-03-22 02:43:02

Health Sciences Authority (HSA) launched Pandemic Special Access Route (PSAR) for important therapeutic products essential for pandemic response. HSA defined the group of products that can apply via this route and the requirements/criteria for submission.

• 2021-03-22 02:30:57

Health Sciences Authority (HSA) released a draft guideline for 3D Printed Medical Devices. This announcement is to clarify current regulatory requirements for 3D printed medical devices and to hear comments from stakeholders. The consultation period for this document will be from January 25, 2021, to February 28, 2021.

• 2021-03-22 02:12:12

In the light of the continuing COVID-19 pandemic, PFDA announced FDA Circular 2020-024-A which extended the validity of Licences to Operate (LTOs) and Certificates of Product Registration/Notification (CPR/Ns) that are expiring from 01 January to 30 June 2021. In addition, PFDA released key documents/announcements affecting medical device transactions to PFDA

• 2021-03-22 01:58:21

On February 25th, Qualtech organized a webinar and guided participants through the China medical device regulations. Our expert covered such topics as registration preparation, registration reviewing process, post-market process.

• 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.