Vietnam Market Introduction
If you are looking for market that you can easy to access or export, you should definitely consider Vietnam.
Vietnam is one of Asia's rising stars, playing a significant role in the region. From its growing population to its economic significance, Vietnam stands out as a dynamic and rapidly evolving country. Here's brief comparison between Vietnam and other nations in Asia.
- Vietnam population : 100 milion
- Rank in Asia : 8th largest population followed by China, India and Indonesia
- GDP : $450 Billion
- Rank in Aisa : 7th in ASEAN
- Global Trade Rank: Among top 30 exporters globally.
How to Register Medical dedvice in Vietnam?
Vietnam's healthcare industry is rapidly expanding, making it an attractive market for medical device manufacturers and distributors. However, navigating the regulatory requirements for medical device registration in Vietnam can be complex. especially for foreign companies. Understanding process, key steps and compliance rules is essential to succeed in this market. This article provides a comprehensive overview of the registration process for medical device in Vietnam, helping you streamline your application and avoid common mistake.
1. Regulatory Authority for Medical Devices in Vietnam
The Ministry of Health (MOH) governs medical device registration in Vietnam. All medical devices must adhere to Vietnam’s Decree 98/2021/ND-CP, which outlines classification, documentation, and approval requirements.
2. Classification of Medical Devices
Medical devices are categorized into four classes:
Class A: Low risk (e.g., bandages, gloves)
Class B: Low-to-moderate risk (e.g., diagnostic kits)
Class C: Moderate-to-high risk (e.g., X-ray machines)
Class D: High risk (e.g., ventilators, implantable devices)
It is similar with Korea classification
Proper classification is critical as it determines the registration pathway. A qualified classification agent can assist in ensuring accuracy.
3. Required Documents for Registration
To register a medical device, the following documents are typically required:
Free Sale Certificate (FSC): Issued by the country of origin.
ISO 13485 Certification: Demonstrates compliance with quality management systems.
Device Labeling Information: Must be in Vietnamese and meet MOH standards.
Clinical Data (for Class C and D devices): Supporting the safety and efficacy of the device.
Technical File: Includes product description, usage instructions, and specifications.
All documents must be notarized and translated into Vietnamese.
4. Appointment of a Local Representative
Foreign manufacturers must appoint a locally-registered company in Vietnam as their in-country representative. This representative handles the submission process and liaises with the MOH.
5. Online Registration Process
Vietnam uses an online platform for medical device registration. The steps include:
Account Creation: Set up an account on the Vietnam Medical Device Registration System.
Application Submission: Upload required documents and pay the applicable fees.
Review Process: The MOH reviews submissions for completeness and accuracy.
Issuance of Registration Number: Upon approval, a registration number is provided, valid for five years.
6. Key Considerations and Timelines
Processing Time: Approval timelines vary depending on the device classification. Class A devices are faster (1-2 months), while Class C and D devices may take up to 12 months.
Post-Market Surveillance: Companies must ensure ongoing compliance through adverse event reporting and product monitoring.
Renewal: Registration must be renewed before expiry to maintain market presence.
7. Common Challenges in Registration
Document Errors: Missing or incorrect information can delay the process.
Translation Issues: Poorly translated documents can lead to rejection.
Local Representative Competence: Partnering with an inexperienced representative can complicate applications.
Providing 2 important Tip!
1. TIP 1
Class 1 and 2 device registration takes less than other country.(!~2month only) and they accept the ISO13485 as a Quality Management System.
This is amazing! if you are interest to export medical device to other country please choose Vietname first!
As you know, it's not easy to find this much quick process considering all other country's requirements.
2. TIP 2
If you register a device in Vietnam, multiple distributors can act as importers unless there is an exclusivity agreement. This is crucial when contracting with distributors and building relationships. To ensure safety, choose a stable representative to manage your post-market vigilance in Vietnam.
Conclusion
Registering medical device in Vietnam involves navigating a complex but well-structured process. By understanding regulatory requirements, preparing accurate documentation, and partnering with a reliable local representative, manufacturers can ensure a smooth entry into the Vietnamese market.
If you’re planning to register a medical device in Vietnam, start by thoroughly reviewing the classification and documentation needs. Proper preparation can save time, reduce costs, and position your products for success in this dynamic market.