February 2022

Malaysia guidance registration refurbished medical devices

Malaysia releases new guidance on registration of refurbished medical devices

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 Medical Device Directive (AMDD), it …

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Malaysia MDA draft guidance classification rehabilitation physiotherapy speech therapy devices

Malaysia MDA releases draft guidance on the classification of rehabilitation, physiotherapy and speech therapy devices

Malaysia’s Medical Device Authority (MDA) has released draft guidance for the classification of rehabilitation, physiotherapy and speech therapy devices.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 of the mode of action …

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Malaysia MDA draft guidance medical device grouping

Malaysia MDA releases draft guidance on medical device grouping classification rules

Malaysia’s Medical Device Authority (MDA) has released draft guidance on medical device grouping classification rules.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 application. This draft guidance applies …

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Indonesia launches dedicated ecatalogue medical devices

Indonesia’s Ministry of Health launches dedicated e-Catalogue for medical devices

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 e-Catalogues which are specific to …

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Philippines Price Limit Covid19 RT PCR Tests

Philippines: Price Limit for Covid-19 RT-PCR Testing

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 are mandated to observe a …

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Philippines FDA: List of registrable IVDs - guidelines for comments

Philippines FDA: List of registrable IVDs – draft guidelines for comments

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 addition of COVID-19 test kits. …

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Indonesia introduces simplified registration for certain class A medical devices

Indonesia introduces simplified registration for some class A medical devices

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 Notification (Izin Edar Notifikasi Alkes …

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malaysia mda launches medcast 2 plus

Malaysia MDA launches MeDC@St 2.0+

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 combine Category 2 and Category …

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philippines fda guidelines distribution and use of covid19 self test kits

Philippines DOH issues guidelines on distribution and use of Covid-19 Antigen Self-Test Kits

The Philippines Department of Health (DOH) has released guidelines on the appropriate procurement, distribution and use of antigen self-test kit on 26 January 2022. The guidelines include instructions to manufacturers, suppliers and distributors on ensuring that the instructions for use are user-friendly including a requirement to create a step-by-step video guide and provide translations. All …

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