• 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.

• 2020-12-24 01:44:02

Ministry of Public Health has announced that direct advertising to medical and public health practitioner are exempted from applying for advertising license,  for the convenience in advertising medical devices.

• 2020-12-23 07:24:48

The Ministry of Health has been issued a decree No. 117/2020/ND-CP dated September 28, 2020 on prescribing penalties for administrative violations in medical sector, effective from November 15, 2020.

• 2020-12-23 07:22:04

The Ministry of Health has issued Directive No. 20/CT-BYT dated October 1, 2020 on strengthening bidding to ensure competition, openness, transparency and efficiency in the health sector.

• 2020-12-23 07:07:34

The Vietnam Ministry of Health has issued Circular No. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. 14“), which regulates various aspects of the bidding process of medical devices for public health establishments. This circular took effect on 1 September 2020.

• 2020-11-26 10:42:10

The German-based “Society for Promotion of East West Knowledge Transfer” had invited the experts of Qualtech to share their knowledge on the Taiwan registration processes for medical devices and pharmaceutical products to a number of high-ranking and selected attendees. Within a 90-minute session held on November 10th, Qualtech guided participants through the different Taiwan certification procedures and further elaborated on the clinical requirements in place for pharmaceuticals.

• 2020-09-15 08:58:35

Thailand’s Ministry of Public Health has announced the medical devices that are exempted form compliance with certain control measures under Section 6 (18) of the Medical Device Act B.E. 2551.

• 2020-09-15 08:54:58

Ministry of Public Health has made an announcement regarding the Declaration Form for Importer to declare when import all the listed medical device that comply with the standards in 2020.

• 2020-09-15 08:44:25

Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.

• 2020-09-15 06:53:41

Ministry of Public Health has made 2 additional announcements regarding the Standards of Medical Device that manufacturer or importer must comply to in 2020.