• 2020-05-12 08:23:22

PFDA reminds the public to buy health products, including medical devices and supplies, only from online sellers with proper authorization/s. In a separate announcement, PFDA released a guidance for manufacturers of PPEs, ventilators and respirators during the COVID-19 pandemic.

• 2020-05-12 06:28:19

Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.

• 2020-04-14 12:02:03

Local health authorities in Asia Allow certain products to be exempted from the regular registration routes and, in some cases, even being eligible to be imported directly.

• 2020-04-14 05:08:33

PFDA implemented FDA Circular No. 2020-001 last March 13, 2020. However, PH government enforced enhanced community quarantine due to COVID-19 pandemic last March 17, prompting PFDA to release several issuances regarding guidelines on PFDA transactions during the quarantine period.

• 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.