News

QT Analysis: Registration of Quality Management System in Taiwan & Japan  - August 2021

QT Analysis: Registration of Quality Management System in Taiwan & Japan - August 2021

  • 2021-08-26 13:03:08

One similar thing about the medical device registration process in Taiwan and Japan is the documentation of the Quality Management System that must be registered with the local regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of QMS documentation of which foreign manufacturers and local authorized representatives should be aware. This article will introduce those major revisions, as well as major differences in the QMS registration processes in Taiwan and Japan.

More
TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

  • 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.

More
QT ANALYSIS: New GDPMD Regulation in Taiwan

QT ANALYSIS: New GDPMD Regulation in Taiwan

  • 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.

More
TAIWAN: New  Draft on “Requirements for Indicating the Unique Device Identifier on Medical Device Labels"

TAIWAN: New Draft on “Requirements for Indicating the Unique Device Identifier on Medical Device Labels"

  • 2020-12-23 02:01:32

TFDA has recently announced a 3-stage schedule of implementing UDI system on labels of medical devices. Starting from June 1st, 2021, class 3 implantable medical devices are the first round of products that are required to comply with this regulation; followed by class 3 non-implantable medical devices starting from June 1st, 2022, and finally, class 2 medical devices starting from June 1st, 2023.

More
QT ACTIVITY: Qualtech Shares its Expertise on the Taiwanese Certification Procedures for MDs and Pharmaceuticals at the Taiwan Health Sector Conference in Germany  – November, 2020

QT ACTIVITY: Qualtech Shares its Expertise on the Taiwanese Certification Procedures for MDs and Pharmaceuticals at the Taiwan Health Sector Conference in Germany – November, 2020

  • 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.

More
TAIWAN: TFDA Announcement: Cease to comply with the regulation regarding "Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR"  – November, 2020

TAIWAN: TFDA Announcement: Cease to comply with the regulation regarding "Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR" – November, 2020

  • 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

More