• 2020-02-21 07:26:10

PFDA released FDA Circular No. 2020-001 as initial implementation of Administrative Order No. 2018-0002 (Guidelines Governing the issuance of an authorization for a medical device based on ASEAN Harmonized Technical Requirements).

• 2020-02-21 07:24:35

Qualtech’s Taipei Office was awarded with the Certificate of Excellence for its Good Distribution Practice in Taiwan by the TFDA.

• 2020-02-21 07:09:30

The Taiwan Council passed the draft of the " Regulations of Medical Devices" (hereafter simply referred to as the “Regulation”) in December 2019. The regulation has medical devices to be legislated independently and thus no longer fall under the Pharmaceutical Affairs Act.

• 2020-02-21 07:07:52

The PFDA released the draft fees in preparation to the authority’s adaptation to the ASEAN Medical Device Directive (AMDD) risk-based classification.

• 2020-02-21 06:56:50

Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement on the Final Draft on Good Distribution Practice for Medical Devices 2020 will be hosted by Medical Device Control Division, Food and Drug Administrative.

• 2019-12-18 09:11:40

Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement will be hosted by Medical Device Control Division, Food and Drug Administrative.

• 2020-07-31 09:31:11

The announcement aims to set a standard and to ensure the direction for the authority in performing an evaluation of HIV screening kit by self-test application.

• 2020-07-31 09:20:55

Thailand FDA is expedient to have amend Announcement regarding the criteria for Full Evaluation and Concise Evaluation dated on October 4, 2019. This amendment aims to be appropriate and consistent with the current situation of the expanding medical device industry.

• 2020-07-31 10:08:37

ThaiFDA sturdily believes that via the implementation of Good Distribution Practice for Medical Devices, manufacturers, importers and distributors must comply to ensure quality, safety and performance throughout the supply chain.

• 2020-07-31 10:23:22

National Committee on Prevention and Solution for AIDS concerned the important of individual infected situation. Encouragement of an action by increasing access Self-diagnosis of HIV infection which will be an essential key that will lead to the end of the AIDS problem.