Malaysia’s Medical Device Authority (MDA) has released draft guidance on medical device grouping classification rules. The draft guidelines are open for comment by stakeholders until 28 February 2022. The purpose of the document is to provide guidance on determining the appropriate grouping for medical devices during the medical device registration
Indonesia’s Ministry of Health has launched a dedicated e-Catalogue for medical devices on Friday 11 February 2022. Previously, one e-Catalogue existed for all products procured by the government from street lighting to pacemakers. This has now been split into a national e-Catalogue for items that are required nationally, and sectoral
The Philippines Department of Health has issued an update to information concerning the Price Limit for Covid-19 RT-PCR Testing. The initial Circular No. 2021-0374 was issued on 26 August 2021. This amendment (Circular No. 2021-0374A) clarifies the price limit and other matters as follows: Turnaround Time for RT-PCR Tests. Laboratories
The Philippines Food and Drug Administration (FDA) is seeking comments from IVD manufacturers and distributors (importers/exporters/wholesalers) on draft guidelines entitled “Specific list of registrable IVD medical devices and revised technical requirements for registration of COVID-19 test kits”. The draft FDA Circular provides a specific list of registrable IVDs including the
Indonesia’s Ministry of Health has announced that it has simplified registration for some Class A medical devices and Classes 1 & 2 of household health supplies (PKRT). Medical Device Distribution Certificate (IDAK, previously called SDAK) holders can take advantage of this new simplified registration by applying for a Distribution Permit
The Malaysian Medical Device Authority (MDA) has launched an enhanced version of MeDC@St, its online application system for medical device registrations, at the end of January 2022. MeDC@St 2.0+ will incorporate additional features such as changes to certain modules including: Change Notification module Change notification applications are now allowed to
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