Tag: Regulatory Updates

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Aug 2024

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations

Consumer Health – USA/Europe/Asia/ROW Regulatory News – March 2024

April 8, 2024
Consumer Health

USA FSIS Guideline for Label Approval This guideline is designed to help establishments determine whether their labels must be submitted to FSIS’ Labeling and Program Delivery Staff (LPDS) for...

Consumer Health News, Food Safety, FSIS Guideline, Health Regulations, Healthcare News, Labeling Guidelines, Regulatory Updates, Standards

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – March 2024

April 8, 2024
Biopharma

USA Three FDA Final Guidance’s on Electronic Submission of Safety Reports Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational...

BioPharma Industry, Global Regulations, Industry News, Pharma Insights, Regulatory Updates

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024

April 3, 2024
Medical Device

USA Accreditation Scheme for Conformity Assessment (ASCA) The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates

Consumer Health – USA/Europe/Asia Regulatory News – Feb. 2024

March 6, 2024
Consumer Health

USA New Directory of Ingredients Used in Products Marketed as Dietary Supplements The U.S. Food and Drug Administration (FDA) has updated the agency’s Ingredient Directory, including renaming...

Asia Health, BPA, Consumer Health News, Dietary Supplements, EUHealth, FDA, February2024, Global Health, Health Regulations, Healthcare News, Medical Guidelines, Regulatory Updates

Medical Devices – Europe, Asia and ROW Regulatory News – Feb. 2024

March 5, 2024
Consumer Health

EUROPE Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices The Commission, after consulting the Member States in...

Compliance, Global Health, Health Policy, Healthcare Industry, Medical Devices, Medical Technology, Regulations, Regulatory Updates