• 2021-04-16 07:42:33

The latest GDP Inspection Timeline announced by Taiwan FDA is brought to you by Qualtech!

• 2021-03-29 01:45:09

Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.

• 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 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.

• 2021-02-22 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.

• 2021-02-22 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 02:20:12

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.

• 2021-02-19 08:45:21

NMPA has introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices, including management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

• 2020-12-24 11:02:25

Thai FDA is committed to ensuring utmost standard, quality and safety of medical devices marketed in Thailand is consistently kept. Hence, they have announced a new medical device complaint channel, complaint record and management system for inspection. This decree is beneficial in providing assurance to consumer regarding safety and prevention of comparable adverse event in the future.