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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 Circular 2021-002-A shall take effect

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

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.

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

The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs, food, and others. Some health

The Food and Drug Administration (FDA) of the Philippines has issued a draft regulation on IVD market authorizations. The draft is open for comments from industry stakeholders until 7 February 2022. Here are the main points of the draft regulation issued by the FDA: New registration, notification and listing certificates specially for In-Vitro Diagnostics will

The Philippines FDA now accepts applications for registration for COVID 19 Self-Test Kits. The Philippines FDA issued Advisory No. 2021-3604 on 29 December 2021 regarding the start of acceptance of submissions for Special Certification of COVID-19 self-test kits that will be effective as of 6 January 2022, in accordance with the following Memorandums: FDA Memorandum No.

The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing authorization holder applied for re-issuance

The Philippines FDA issued Circular no. 2021-025 listing the latest guidelines for the application of FDA authorizations in light of the extended state of public health emergency. The extended state of emergency came into effect on 13 September 2021 by Proclamation no. 1218 and will last until 12 September 2022 unless lifted earlier or extended