• 2020-12-24 11:05:44

TFDA has announced a new draft about Good Distribution Practice (GDP). This practice requires distributors who import and/or sell medical devices or who hold medical device registration licenses (license holders) to set up a good distribution system. This is to ensure their quality and integrity are constantly maintained. In this article we have listed important points for distributors to comply with the GDP guideline, throughout the process of importation, transportation, storage, sale and post-market services competent authority and obtaining a distribution license.

• 2020-12-23 02:21:33

MDA has announced a new search database, Medical Device Authority Register (MDAR).

• 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 06:35:40

MDCG has published a guidance for notified bodies on the use of MDASP audit reports in surveillance audit carried out under MDR/IVDR. For those with similar or equivalent requirements, positive QMS conformity result might lead to a reduction of the focus on covered aspect.

• 2020-06-16 08:03:29

PMDA has announced of organizational restructuring of Office of International Programs, aiming strengthening of cooperative relationship with Asian countries.

• 2020-05-12 08:20:00

A new guidance document on this has been issued with the requirements to be followed: All orphaned, obsolete and discontinued medical device still in active use must now be notified with MDA.

• 2020-05-12 08:06:46

In order to tackle the threat of COVID-19, PMDA takes some measures to speed up the development of medical products for COVID-19. Now, timeline for clinical trials are shortened and IRB meeting are allowed to be held in unconventional ways.

• 2020-04-14 08:36:06

Malaysia makes efforts to keep the Covid-19 outbreak contained in the country. Medical Device Authority issued a few more important advisories.

• 2020-04-14 01:28:54

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .

• 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices.