Regulatory Blog

Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)

USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A

Malaysia’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device

EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials

SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments

Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators

USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices

Swiss Medic Guidance: Document on Formal requirements

SFDA Med.Dev: Guidance on National Diagnostic Reference Levels

EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices

Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device

USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions

Australia TGA: FAQ Importing & Supplying Medical Devices

Irelands HPRA's: Guide to Fees for Human Products

SFDA MD Guidance: Requirements for Clinical Trials of Medical Device

UK MHRA: MD Guidance - Register Medical Devices to Place on the Market

Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD

Singapore HSA MedDev: Regulatory Guidelines for Laboratory Developed Tests (LDTs)

Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland

USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”