QT ANALYSIS: 台灣藥品優良運銷規範(GDP)檢查實施時程
- 2021-04-16 07:42:33
由理工科技為您帶來台灣衛生福利部食品藥物管理署最新公布之藥品優良運銷規範GDP檢查實施時程流程圖!
了解更多由理工科技為您帶來台灣衛生福利部食品藥物管理署最新公布之藥品優良運銷規範GDP檢查實施時程流程圖!
了解更多Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.
了解更多In Malaysia, Post-Market Surveillance and Vigilance (PMSV) is regulated under the Medical Device Act 2012 (Act 737) and Medical Device (Duties and Obligations of Establishment) Regulations 2019. In this edition of QT Analysis, tag along with us to keep updated on the latest PMSV requirements in Malaysia.
了解更多Department of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.
了解更多After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.
了解更多Thai FDA has announced the official medical device registration guidance for Licensed medical device and Notified medical device and Listing after promptly complete a transition from policy-based classification to risk-based classification of medical devices.
了解更多Health Sciences Authority (HSA) launched Pandemic Special Access Route (PSAR) for important therapeutic products essential for pandemic response. HSA defined the group of products that can apply via this route and the requirements/criteria for submission.
了解更多Health Sciences Authority (HSA) released a draft guideline for 3D Printed Medical Devices. This announcement is to clarify current regulatory requirements for 3D printed medical devices and to hear comments from stakeholders. The consultation period for this document will be from January 25, 2021, to February 28, 2021.
了解更多In the light of the continuing COVID-19 pandemic, PFDA announced FDA Circular 2020-024-A which extended the validity of Licences to Operate (LTOs) and Certificates of Product Registration/Notification (CPR/Ns) that are expiring from 01 January to 30 June 2021. In addition, PFDA released key documents/announcements affecting medical device transactions to PFDA
了解更多On February 25th, Qualtech organized a webinar and guided participants through the China medical device regulations. Our expert covered such topics as registration preparation, registration reviewing process, post-market process.
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