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
The implications of the halal certification process for medical devices incorporating animal products in Indonesia Catering to Indonesia’s growing need for halal products Indonesia accounts for the largest Muslim population worldwide. With approximately 225 million Muslims, there is an increasing demand for Halal products. In response to this growing need,
The Philippines FDA has set new performance requirements for the various types of COVID-19 test kits available on the market in the Philippines with immediate effect. The PFDA issued Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” on 23rd March 2021 which applies
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