The Philippines Food and Drug Administration (FDA) recently released a draft for comments on the List of Class A Medical Devices for FDA registration in the Philippines. The List of Class A Medical Devices helps medical device industry stakeholders to determine the appropriate risk classification of their device in order
Singapore’s Health Sciences Authority (HSA) has recently launched an interactive self-help tool to guide the grouping of medical devices. Certain medical devices may be grouped together in one application to facilitate medical device registration in Singapore. The chief feature of this tool is its interactive Q&A format. The platform guides
The Medical Device Authority (MDA) in Malaysia released the second edition of a guidance document on In Vitro Diagnostic Medical Device Product Grouping (MDA/GD/0054). IVD devices are regulated medical devices in Malaysia. IVD devices can include, for example, reagents, calibrators, sample collection and storage devices, control materials and related instruments
The Philippines Food and Drug Administration (FDA) has issued Advisory No.2021-0684: “Guidelines on the process of the issuance of Special Certification of COVID-19 Test Kits” which updates the process of applying for a Special Certification of COVID-19 test kits. In essence, applications for Special Certification for COVID-19 Test Kits, require
The Philippines Food and Drug Administration (FDA) recently released a draft for comments on an Addendum to FDA Circular 2021-002: Full implementation of FDA Administrative Order No. 2018-00021. FDA Circular 2021-0002 introduced the guidelines for the filing of applications and issuances of Certificates of Medical Device Notification (CMDN) and Certificates
The Malaysian Medical Device Authority (MDA) has recently published the first edition of a guide listing the requirements for applying to obtain approval for medical device advertisements from the MDA entitled “Application for medical device advertisements approval – requirements” (MDA/GL/04). This document provides an overview of the application procedure for
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