• 2023-06-28 09:46:17

Correction action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.

• 2023-05-24 07:15:51

The applicable expedited route from the Thai FDA supplies much-needed clarity for manufacturers, allowing them to better forecast the potential impact on timelines and costs for certain products. The selection of expedited routes allows applicants to comply according to their medical device approval status.

• 2023-03-27 09:16:15

The Medical Device Authority (MDA) published the Fifth Edition Guidance Document, "Guideline for Registration of Drug-Medical Device and Medical Devie-Drug Combination Products", on January 03, 2023. This document is intended to provide information on how to apply for an endorsement letter, post-approval changes/variation applications for ancillary components, adverse drug reactions and incident reporting for the registered combination product.

• 2023-03-27 08:27:31

Thai FDA announces 'Thailand FDA - WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)', an expedited medical device registration program aimed at reducing the time required for manufacturers and importers to register their products. The program officially commenced on December 28, 2022, onward.

• 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

• 2022-11-29 01:55:34

PFDA issued FDA Circular No. 2022-008 that provides a guideline on the abridged process for registration of medical devices among ASEAN member countries.

• 2022-10-25 07:28:38

NMPA decided to start using electronic payment for drug and medical device registration fees.

• 2022-10-25 07:24:41

Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.

• 2022-07-26 11:19:48

The Medical Device Authority (MDA) published a guideline document to provide information and explanation to establishments on how to submit a re-registration of registered medical device applications in Malaysia. The document prescribes the requirements for re-registration of registered medical devices for medical device registration applications that are about to expire or have already expired.

• 2022-04-27 11:32:12

Concerning the rapid development of Artificial Intelligent/Machine Learning-Based SaMD, TFDA has updated the related guidance that was initially announced in 2020. The latest requirements are summarzied in this article.