The Philippines FDA issued an amendment to Circular no. 2021-002-A entitled “Addendum to FDA Circular No. Circular no. 2021-002 Re: 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 Circular for comments amending FDA
The Malaysian Medical Device Authority (MDA) has released guidance on the requirements for registering Refurbished Medical Devices (MD/GD/0060). The guidance document provides information on how to register a refurbished medical device before it can be placed in the Malaysian market. What is a refurbished medical device? According to the ASEAN
Malaysia’s Medical Device Authority (MDA) has released draft guidance for the classification of rehabilitation, physiotherapy and speech therapy devices. Industry stakeholders are invited to comment on the draft guidelines until 2 March 2022. The guidance states that the classification as a medical device will be made upon the clear indication
Malaysia’s Medical Device Authority (MDA) has released draft guidance on medical device grouping classification rules.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
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