• 2020-12-24 02:53:02

A person who wishes to advertise a medical device in Thailand must obtain a medical device advertising license upon any medical devices marketing activity. Thai FDA had published further advertising announcement regarding the advertising specifications of medical devices that are exempted to proceed advertising license registration to conveniently advertise medical devices.

• 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.

• 2020-11-26 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.

• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.

• 2020-11-26 10:42:10

The EUDAMED actor registration module will be available starting December 2020. All the economic operators should request single registration number (SRN) through this module, including manufacturers, authorized representatives, system/procedure pack producers, and importers.

• 2020-11-26 10:19:14

Japan has introduced a set of changes, aiming to market innovative products as fast as possible to help patients in Japan with deadly diseases. One of the changes implemented is Fast-Track Approval Scheme.

• 2020-11-26 01:31:52

Thailand is currently gearing up a step closer toward the transition of Thailand future regulation from Policy – based Classification to Risk-based Classification as Thailand’s Food and Drug Administration announced that it is mandatory for importer to prepare Technical Documents (CDST Dossier) upon importation by the period as follows : 1) Class 1, 2 and 3: 13 June 2021. 2) Class 4: 11 September 2021. Licensee who fails to comply with ThaiFDA must be sentence to penalty condition is as follows:
1. Licensed and Notified Medical Device: Shall be liable to imprisonment for a term not exceeding 1 year or fine not exceeding 100,000 THB or both.
2. General Medical Device: Shall be liable to imprisonment for a term not exceeding 6 months or fine not exceeding 50,000 THB or both.

• 2020-10-30 09:18:20

As the pace of technology is advancing exponentially, the effect of improving the quality of health and performance in the healthcare environment is significantly valued.