WTO notification · TBT
PhilippinesProposed measure, open for comments
Official title
Rules and Regulation on the Conduct of Clinical Investigation of Medical Devices and Clinical Performance Studies of In-Vitro Diagnostic (IVD) Medical Devices
The Philippines notified this proposed TBT measure to the WTO on 24 September 2026. Comments are open until 23 November 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Health care technology
Comments on a notification go from government to government. If this measure affects your exports, send your comments to your country's WTO TBT enquiry point before 23 November 2026, quoting the document symbol G/TBT/N/PHL/377 and how the measure affects your products. Your enquiry point forwards them to the Philippines.
Find your country's enquiry point on WTO ePing (opens in a new tab)The proposed Administrative Order aims to provide guidelines on the conduct of clinical investigation of medical devices and clinical performance study of in-vitro diagnostic medical devices. This Order adopts the relevant provisions of: PNS ISO 14155:2022 entitled 'Clinical investigation of medical devices for human subjects – Good clinical practice'; PNS ISO 20916:2022 entitled 'In-vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice'
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
Notified documents
WTO notificationTBTProposed measure, open for commentsNew
The proposed FDA Circular aims to provide GMP guidelines for medical devices under PNS ISO 13485:2019. This Circular shall apply to all local manufacturers of medical devices, including IVD medical devices.
Symbol: G/TBT/N/PHL/379Comments until 2 January 2027
WTO notificationSPSProposed measure, open for commentsNew
This Circular is hereby issued to provide the updated guidelines and implementation procedures for the importation of dogs and cats into the Philippines. It outlines the documentary and animal health requirements, including the approved Sanitary and Phytosanitary Import Clearance (SPSIC), rabies…
Symbol: G/SPS/N/PHL/548Comments until 2 January 2027
WTO notificationTBTProposed measure, open for commentsNew
This Department Administrative Order (DAO) aims to establish the mandatory product certification requirements for specified Light Electric Vehicles (LEVs) and batteries for LEV applications intended for importation, manufacture, distribution, or sale in the Philippines, to ensure conformity with…
Symbol: G/TBT/N/PHL/378Comments until 13 December 2026
WTO notificationSPSProposed measure, open for commentsNew
This regulation provides clarifications on the hierarchy of food safety standards that have already been established and adopted as technical regulations, serving as points of reference for government agencies, international trading partners and local stakeholders. The scope of this regulation…
Symbol: G/SPS/N/PHL/547Comments until 19 December 2026
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