Vietnam’s economy has been rapidly emerging over the last few years, and the medical device market is one of the many beneficiaries of this growth. About 70% of medical device purchases made in Vietnam — measured in terms of value — go to public hospitals. Due to Vietnam’s ease of market access and less regulation on imported devices, enormous opportunities exist for foreign companies aiming to grow their revenue.
The international medical device specialists at Pacific Bridge Medical have extensive experience with Vietnam’s regulations and can help you register and obtain approval for your product.
Click on the following questions to read more details about medical device registration and approval in Vietnam.
Which regulatory bodies in the Vietnamese government are responsible for medical device registration in Vietnam?
- The Department of Medical Equipment and Health Works (DMEHW) is the regulatory body that governs the registration and approval of medical devices in Vietnam.
- The Ministry of Science and Technology handles certain aspects of domestic medical device registrations.
In Vietnam, are medical devices required to be registered before they can be sold?
Although all types of domestically manufactured medical devices require registration, only certain types of imported medical devices require licenses.
What are the different regulatory classifications for medical devices?
There is no classification system for medical devices in Vietnam. The following medical devices require import licenses in order to be imported and sold in Vietnam:
- Medical devices to be implanted into the human body, or which replace or supplement a physical function.
- 54 types of medical devices, which are specifically listed in Appendix 7 of the MOH’s Circular No. 08/2006/TT-BYT, issued June 13, 2006. (Example devices include: image diagnosis devices, electro-cardiographic apparatus of various kinds, radio therapeutic devices, long-term grafting and culture materials, etc.).
- Devices that have a new function or new therapy, or devices that are being imported to Vietnam for the first time.
What does the registration pathway look like for medical devices requiring import licenses in Vietnam?
- The applicant must ensure compliance with the following conditions:
- The foreign manufacturer’s technical personnel must be sufficiently trained by the manufacturer on an annual basis.
- The manufacturer’s chief technician must hold a diploma as defined in the MOH’s Circular No. 08/2006/TT-BYT.
- Prepare the application dossier.
- Submit the dossier (application and supporting documents) to the DMEHW.
- The DMEHW reviews and evaluates the applicant’s dossier.
- The DMEHW generally makes a decision within 3-4 months.
What are the document requirements for registration in Vietnam?
The application dossier submitted to the DMEHW must include the following documents:
- The application form.
- Relevant documents demonstrating compliance with the conditions specified in item 1 listed in the question above.
- The original catalog of each type of device.
- The instruction manual and technical guide with the device specifications in both. In addition to the original versions, the Vietnamese translated versions of these documents are also an essential requirement.
- The manufacturer’s quality certificate (FDA approval or ISO 13485 certificate).
Is local testing (type testing/sample testing) required for registration?
No, local testing is not required for registration in Vietnam.
When are clinical studies required for registration?
Medical devices that have not previously been imported to Vietnam, which also incorporate a new functionality or therapy, require clinical trials. Foreign clinical trials are generally accepted; however, in certain cases the DMEHW may request MOH-conducted local clinical trials.
Is approval in the Country of Origin required for registration?
Country of Origin approval, U.S. FDA approval, or a CE Mark certificate is required for registration in Vietnam.
Contact us today for a consultation with our Vietnam medical device regulatory experts.
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