PHL/371
WTO/TBT
Philippines - 90 - Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof
2026-10-09
2026-07-28
Instruments and appliances used in medical, surgical, dental or veterinary sciences, incl. scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments, n.e.s. (HS code(s): 9018)
Guidelines on the Application for Variation of the Issued Product Authorizations for Medical and Health-Related Devices; (14 page(s), in English)
This proposed FDA Circular provides comprehensive guidance on variation applications of medical device and health-related product and introduces a risk-based approach for Medical Device Software. Furthermore, these guidelines partially adopt the Global Harmonization Working Party (GHWP) principles on Change Management.
https://members.wto.org/crnattachments/2026/TBT/PHL/26_03884_00_e.pdf
https://members.wto.org/crnattachments/2026/TBT/PHL/26_03884_01_e.pdf
https://www.fda.gov.ph/draft-for-comments-guidelines-on-the-application-for-variation-of-the-issued-product-authorizations-for-medical-and-health-related-devices/
https://members.wto.org/crnattachments/2026/TBT/PHL/26_03884_01_e.pdf
https://www.fda.gov.ph/draft-for-comments-guidelines-on-the-application-for-variation-of-the-issued-product-authorizations-for-medical-and-health-related-devices/