SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels
USFDA MD Guidance: Breakthrough Devices Program - Reducing Disparities in Health & Health Care
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
Philippines FDA: Guidelines on the Unified Licensing Requirements
USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension
USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests
USFDA Guidance: Six Finalized Medical Devices Guidelines
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
UK MHRA's Guidance: Software Applications (apps)
Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN
SwissMedic Guidance: On Export Certificates
Colombia INVIMA: Guidelines on the Application related to Sanitary Registries of Medical Devices
Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)
USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products