The Philippines Food and Drug Administration (FDA) has extended the date for comments on a draft Circular on Banning all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes. Comments may be submitted until 14 August 2021. This draft circular follows guidelines issued in
The Ministry of Health in Indonesia is simplifying the registration process for 34 Class A medical devices as well as some Class I and II Household Health supplies (Perbekalan Kesehatan Rumah Tangga or PKRT). The new process will require SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC)
The Philippines FDA (Food and Drug Administration) has published a draft version of “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines”. This draft is now open for comments from concerned parties until 24 July 2021. The draft guidelines specify those establishments that are required to obtain
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
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