EU Authorized Representative (EAR) Role, Responsibilities & Appointment Process
Appointing an EU Authorized Representative is the most important step for IVD or medical device manufacturers established outside the European […]
MedTech Insights
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Medical Device Regulations and Registration Process in Mexico
Before entering the Mexican market, medical devices need Registro Sanitario, or Sanitary Registration. Recently, regulatory simplification and a broader abbreviated
ISO 14971 Risk Management File (RMF) for Medical Devices
Risk management is an important aspect in the development of medical devices. Performing risk management is a regulatory requirement in
Medical Device Regulations and Registration Process in South Africa
South Africa Medical Device Regulations don’t require product registration yet, for any device class. What’s actually needed is an establishment
Medical Device Regulations and Registration Process in Israel
Israel’s Ministry of Health Medical Equipment Division doesn’t run an independent approval system for medical devices and that’s the first
Medical Device Regulations and Registration Process in Turkey
Ask a manufacturer what they think Turkey Medical Device Registration involves, and most will say “get CE marked and you’re
Medical Device Regulations and Registration Process in Egypt
Egypt is the second-largest medical device market in the MENA region, and it runs mostly on imports. That’s why Medical
Medical Device Regulations and Registration Process in Russia
Russia is a member of the Eurasian Economic Union (EAEU), alongside Armenia, Belarus, Kazakhstan and Kyrgyzstan. Medical Device Registration in
510(k) Submission Process for Medical Devices
A 510(k) is also referred to as a premarket notification, is one of the major pathways for bringing devices to