USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
UK updated Guidance: Register Medical Devices to Place on the Market
India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A
South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction
Ireland's HPRA -Guide to Performance Studies Conducted in Ireland
USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device
USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT
USFDA's Guidance of Electromagnetic Compatibility (EMC) of Medical Devices
Free eBook- CAPA in the Pharmaceutical and Biotech Industries
Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group
Cybersecurity of Legacy Medical Devices - Guidance-IMDRF