• 2020-03-16 06:31:12

In a latest announcement, MDA has announced that unregistered face masks shall henceforth be placed in the market via a Special Access route.

• 2020-02-21 07:28:40

VN MOH released the Decree 03/2020, to amend Decree 36 & 169, which is effective from Jan 1, 2020. Below are remarks relating to the imported Medical Device as below: Qualtech marks up the different place comparing to Decree 36 & 169.

• 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed

• 2020-02-21 07:27:21

January 8th, 2020 has marked the day of Qualtech’s extensive workshop on the new European Medical Device Regulations (MDR) for its Taiwanese clients. The event provided its attendees with the latest updates on the MDR implementation before the end of the transition period on May 26, 2020.

• 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 07:25:15

Having witnessed the changing and rapidly developing landscape of many Southeast Asian countries and their medical device markets, Qualtech has outlined the most convincing factors and trends on why you should definitely consider expanding your business to the ASEAN markets.

• 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 07:23:38

Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself.

• 2020-02-21 07:22:04

Earlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.

• 2020-02-21 07:21:24

MDA has introduced new revisions to the Guidance Document on Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.