Medical Device

Our company provides various services for the medical device industry, including consulting, classification, registration, agents and so on.

Medical device refers to any device and related articles used to treat, diagnose, prevent, or cure diseases. Medical devices play an important role in enhancing the health of global patients, which is essential for medical care.

However, there are some potential risks in the medical device industry, so it must be strictly regulated to ensure safety. The regulatory policies, definition and scope of different countries have slight difference. As a result, it is very critical to develop a reasonable and registration project according to the requirements and norms of local regulatory policies.

The global medical device industry is one of the fastest growing healthcare markets. As a leading medical device service platform, Proregulations focuses on the medical device's registration and approval. We have a professional team, acquaint with the regulatory policies of medical devices in many countries, aiming to help customers avoid registration risks, adopt reasonable strategies, save operating expenses, and accelerate the process of product marketization, which will be your trusted partners.  

One-stop Solution for Medical Device Industry

Our main services in the medical device industry include:

North America

• U.S. Medical Device Registration with the FDA
• U.S. Medical Device 510(k) Premarket Notification
• U.S. FDA Medical Device Establishment Registration and Listing
• U.S. FDA Local Agent for Medical Device and IVD

China

• China Medical Device Registration and Device Classification

• Medical Device Testing

• Medical Device Biocompatibility Testing
• Medical Device Microbiological Testing
• Medical Device Chemical Characterization
• Medical Device Packaging Testing

• Medical Device Distributor License

We provide professional services for the medical device industry from registration to listing, including but not limited to:

• Interpretation of regulations, consultation on approval procedures, professional training;
• Testing and classification
• Submit the application
• Establishment of the registration
• Local agent for medical devices and IVD in North America

Technical Service Capability

Our company provides the global medical device industry with listing services in North America and China, covering regulatory consultation, testing, classification, and data submission to the entire process of successful listing. No matter what difficulties you encounter in the the process of the registration, we will provide you with professional solutions in the shortest time, improve the efficiency and success rate of listing approval, shorten the project cycle, and create higher benefits. If you need help or have a question, please feel free to contact us for more details.