Registering a Class C medical device with the Vietnam Ministry of Health (MOH) involves specific fees and processing times.

Registration Fee:

• The fee for Class C medical device registration is VND 6 million (approximately US$240). 

Processing Time:

• The MOH aims to process Class C device registrations within 10 to 90 days. 

• However, actual processing times can vary significantly. Some applications have experienced delays, with approvals taking one year or more. 

Factors Influencing Processing Time:

• Completeness of Documentation: Ensure all required documents are accurate and complete to avoid delays.

• Reference Country Approvals: Devices approved by recognized regulatory authorities (e.g., FDA, CE, TGA) may benefit from expedited reviews. 

• MOH Workload: The volume of applications can impact review timelines.

Recommendations:

• Thorough Preparation: Submit a comprehensive and accurate application to facilitate a smoother review process.

• Engage Local Expertise: Collaborate with a local authorized representative familiar with Vietnam's regulatory landscape to navigate the process effectively.

By proactively addressing these factors, you can help ensure a more efficient registration process for your Class C medical device in Vietnam.

Contact Us：

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