The Code of Advertisement is a Guidance Document (MDA/GD/0032) issued by the Malaysian Medical Device Authority (MDA) to ensure good marketing practices and advertising messages that are socially responsible and ethical. It forms part of the Medical Device (Advertising) Regulations 2019 in Malaysia that were fully implemented on 4 May
The Vietnamese Ministry of Health (MoH) has published a draft decree which is intended to replace Decree No. 36/2016/ND-CP and its amendments, which currently form the legal framework for regulating medical devices in Vietnam. The draft was released as Official Dispatch No. 2271/BYT-TB-CT on 31 March 2021. In order to
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
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
