WebThe ASEAN has drafted the Common Submission Dossier Template (ASEAN CSDT), based on the GHTF STED for medical devices. Based on this document, ASEAN … Web6 sep. 2024 · While local laws of Singapore, Malaysia and Indonesia have fully complied with the ASEAN Medical Device Directive, it is encouraging to see more developments of various Member States in ASEAN this year. From the report of the 8th ASEAN Medical Device Committee Meeting and Related Activities – Industry Training Sessions and …

What is CSDT and How to Use It. - Asia Actual

WebCommon Submission Dossier Template (CSDT) - Medical Device Authority (MDA) Utama. Bahagian. Counter Appointment. Laman Utama. Dokumen. GUIDANCE … Web26 feb. 2024 · The authority also has a program, dating from January 2024, under which it is prepared to share evaluation reports to help the Thai FDA approve products faster, provided they have undergone full evaluation and are already approved in Singapore. The system is based on use of the ASEAN Common Submission Dossier Template (CSDT) form. mit pantheon project

Malaysian Medical Device Registration Requirements

Web11 aug. 2024 · The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical … Web24 mei 2024 · Published on: May 24th, 2024 On May 15, 2024, the VietNamese Ministry of Health (MOH) released new Guidance announcing Class B, C, and D devices will need to submit their applications in accordance with the ASEAN Common Submission Dossier Template (CSDT) format. WebThe draft device registration requirements released in September 2014 better align the Philippines with ASEAN’s Common Submission Dossier Template (CSDT). In the near future, the classification rules shall be based on the ASEAN Medical Device Directive (AMDD). CLASS A – Low risk (e.g. bandages) CLASS B – Moderate risk CLASS C – … ingersoll rand oil t30