QT ANALYSIS: Taiwan Good Distribution Practice (GDP) Inspection Timeline
- 2021-04-16 07:42:33
The latest GDP Inspection Timeline announced by Taiwan FDA is brought to you by Qualtech!
MoreThe latest GDP Inspection Timeline announced by Taiwan FDA is brought to you by Qualtech!
MoreDue 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.
MoreIn 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.
MoreDepartment of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.
MoreAfter 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.
MoreThai 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.
MoreHealth 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.
MoreHealth 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.
MoreIn 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
MoreOn 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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