• 2024-04-03 09:56:03

On January 23, 2024, Indonesia's Ministry of Health has published an announcement emphasizing the compliance with the latest regulations for medical device distributors. Existing IPAK (Izin Penyalur Alat Kesehatan) holders need to transition to IDAK (Izin Distributor Alat Kesehatan) as the updated Medical Device Distributor License through the Online Single Submission (OSS) website.

• 2022-07-26 11:22:27

PFDA released a draft circular that provides the requirements for good storage and distribution practices for medical devices, to serve as guidelines for medical device establishments in the Philippines.

• 2021-09-29 02:11:24

MDA wants to advise any organization interested to import and distribute the Covid-19 Self-Test Kit for the Malaysian market to apply through the Conditional Approval Application with MDA.

• 2021-08-26 11:57:56

The MDA has published new guidelines for temporary conditional approval for the COVID-19 self-test kit (COVID-19 RTK), which explains the application procedure and requirements that need to be followed by the establishment.

• 2021-08-02 06:16:13

Thai FDA progressively issues series of guidelines to enhance the new medical device act. This month will be focusing on the latest requirement on medical device manufacturing, importation, and distribution records or report preparation.

• 2021-04-26 03:09:33

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.

• 2021-04-16 07:42:33

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

• 2020-10-15 05:09:36

FAQs for TFDA Good Distribution Practice (GDP)

• 2020-07-16 07:22:55

Taiwan’s FDA has issued a Good Distribution Practice Guideline for Medical Devices. With the new guidelines getting into force in the near future, relevant distributors will be required to obtain a GDP certificate before they can legally distribute medical equipment.

• 2020-05-14 09:43:07

The online event represents the second webinar in our 2020 series and will be held on June 17th, 2020 (Wednesday) at 11am (GMT+8). Shall this Webinar be of interest to you or one of your colleagues, please be sure to register under the following link (limited seats available).