Regulatory Affairs Advance | Regulatory Affairs

Case Study: Regulatory Affairs in MedTech

Strengthening Compliance: Taiwan Releases Preclinical Testing Standards for Key Medical Devices

Here are essential deadlines, new post-market surveillance rules, and compliance strategies for unin...

Accelerating Innovation: Saudi Arabia’s Fast Track Pathways for Innovative Medical Devices

Mastering Regulatory Compliance: Insights from Singapore’s Good Submission Practice Workshop 2024 Si...

Exploring the complex landscape of EU regulations for medical devices and in-vitro diagnostic device...

Navigating the New FDA Guidance on Electronic Submissions for De Novo Requests: What Regulatory Professionals Need to Know

In August 2024, the FDA released significant guidance impacting the Medical Device De Novo submissio...