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
The Thai FDA has issued new regulations for medical device classification and registration part of which came into effect on 15th February 2021 and the remainder comes into effect on 17th March 2021. The new regulations include changes in product classification for both IVD and non-IVD medical devices, types and stages of submission,
All medical devices to enter Thailand, whether manufactured domestically or imported, are regulated by the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Currently, the registration of medical devices is classified according to the level of control, which lists 3 levels: Licensed Medical Devices Notified Medical
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