A Unique Device Identification consultation is underway in Singapore. The Health Sciences Authority (HSA) has issued a draft document entitled “Guidance on the Medical Device Unique Device Identification (UDI) System” so that stakeholders can provide feedback on the document. The consultation is open now until 30 June 2021. Singapore does
The Philippines FDA has announced a virtual consultation on the draft Reference List of Class A Medical Devices and the draft addendum to the Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”.
The Malaysian Medical Device Authority has issued an announcement reminding medical device manufacturers, distributors and the public that the Medical Device (Advertising) Regulations 2019 were implemented on 4 May 2021. With full enforcement of the regulations commencing on 1 January 2022. In the meantime, manufacturers, distributors, advertising agencies and other
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
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