News

QT ACTIVITY: 2021年新醫療器材管理法實施重點研討會

QT ACTIVITY: 2021年新醫療器材管理法實施重點研討會

  • 2021-04-20 03:15:16

衛生福利部食品藥物管理署公告「醫療器材管理法」於110年5月1日正式實施。因應近期多項新法令之要求,理工科技顧問股份有限公司舉辦「2021年新醫療器材管理法實施重點」,協助廠商了解醫療器材新法令之要求及相關規定,並討論因應措施。報名日期自即日起至5月21日,額滿為止,敬請廠商踴躍報名!

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
USA: Post-Approval Studies Program

USA: Post-Approval Studies Program

  • 2021-04-26 02:48:33

In order to ensure the safety and effectiveness of medical devices, the FDA has the Post-Approval Studies Program for 3 kinds of applications. There are Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and Product Development Protocol (PDP). Applicants for these categories should follow the conditions from Post-approval studies to maintain product legality.

More
USA: 522 Postmarket Surveillance Studies Program

USA: 522 Postmarket Surveillance Studies Program

  • 2021-04-26 02:44:41

The Center for Devices and Radiological Health (CDRH) has established an internal tracking system for 522 postmarket surveillance studies, where each product applicant can view the status and timeline of their products when the FDA requires the 522 postmarket surveillance study.

More
AUSTRALIA: TGA Therapeutic Goods Amendments Act 2021

AUSTRALIA: TGA Therapeutic Goods Amendments Act 2021

  • 2021-04-26 02:39:59

Australia Department of Health (DoH) Therapeutic Goods Administration (TGA) has made some amendments and issued the Therapeutic Goods Amendments (2020 Measures No. 2) Act 2021, focusing on unique device identification (UDI) under Therapeutic Goods Act 1989.

More
China: Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council

China: Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council

  • 2021-04-26 02:33:36

On December 21, 2020, State Council in China announced the adoption of New Regulations on the Supervision and Administration of Medical Devices (Medical Devices Order. 739 of the State Council). Respectively on March 18, 2021, State Drug Administration officially issued the revised Regulations on the Supervision and Administration of Medical Devices, corresponding with a set of Draft Measures.

More