Guide to Medical Device Registration in Vietnam

For foreign manufacturers and investors looking to navigate medical device registration in Vietnam, this guide provides a clear roadmap. It explores the specifics of the registration process, key requirements, and important regulations related to labeling and imports, ensuring a successful market entry.

Overview of the Medical Device Industry in Vietnam

What Are The Classifications of Medical Devices in Vietnam?

The classification system for medical devices in Vietnam aligns with the ASEAN Medical Device Directive (AMDD) which is based on the potential risk associated with the use of the device. Classification is a key factor in determining the registration process for the device you intend to market within the country:

• Class A: Low Risk
• Class B: Low to Moderate Risk
• Class C: Moderate to High Risk
• Class D: High Risk

If a device has multiple uses with different risk levels, it is classified based on the highest risk level. Additionally, the classification depends on several factors including:

• Active or non-active device
• Duration of use
• Invasiveness
• Therapeutic vs diagnostic function

Classifications also affect the review timeline and registration fees. Higher classifications will require extensive documentation and a longer review process by their designated local governing units. 

Key Requirements for Medical Device Registration in Vietnam

To successfully register a medical device in Vietnam, several requirements must be met to ensure compliance with local regulations. Understanding these requirements is crucial for companies aiming to introduce their products into the Vietnamese market. Below is a breakdown of the key regulations involved in the medical device registration process in Vietnam:

• ISO 13485:2016 Certificate: Mandatory for all medical device registrations in Vietnam, except for those accompanied by a Certificate of Free Sale (CFS) from countries with recognized regulatory bodies, such as the European Union, Japan, Canada, Australia, and the USA. The Vietnam embassy in the manufacturer’s country of origin must authenticate the CFS.
• Product Licenses: Product licenses are a crucial component of the registration process and are valid for the lifetime of the product. There are two main types of licenses:
  • Declaration of Applicable Standard: Required for Class A and B medical devices, this document certifies that the product complies with the applicable standards set by Vietnamese authorities.
  • Circulation Registration Certificate: Necessary for Class C and D medical devices, this certificate allows the product to be legally sold and distributed in Vietnam. These products typically involve higher levels of risk and require more extensive regulatory oversight.

Three Routes for Foreign Companies to Register Medical Devices in Vietnam

Foreign companies seeking to register medical devices in Vietnam have three possible routes to navigate the regulatory process:

• Establishing a Legal Entity in Vietnam: Companies can obtain an Establishment License from the Department of Finance. This requires setting up a legal entity in Vietnam, allowing the company to manage the registration process directly and conduct business within the country.
• Appointing a Local Importer or Distributor: Foreign companies can opt to work with a local importer or distributor who will handle the registration and commercialization of the medical device in Vietnam. This option allows foreign companies to avoid establishing a legal entity but requires a trusted local partner.
• Engaging an Independent Third Party: Companies may also choose to appoint an independent third party that possesses all necessary certifications. This third party would manage the registration process and ensure the device complies with local regulatory requirements.

Emerhub provides comprehensive end-to-end services to help you register your medical devices in Vietnam. This includes acquiring an Establishment License by establishing a legal entity for your business in the country. Additionally, we offer local import and distribution services, ensuring full compliance with all regulatory requirements to support your planned business activities.

Labeling Regulations for Medical Devices in Vietnam

Proper labeling is crucial in preparing your medical devices for sale and distribution in Vietnam. Remember that labeling regulations can differ from country to country, meaning that foreign manufacturers often need to update labels for the Vietnamese market. The country enforces strict labeling requirements and compliance is essential to avoid penalties from local authorities. Labels must include:

• Name and address of the legal manufacturer (device owner)
• Name and address of the registration number owner (company or individual who is the registrant)
• Registration number or import license number (if the registration number is unavailable)
• Batch or serial number
• Manufacture date or expiry date
• Warnings
• Instructions for use
• Instructions for storage
• Origin of goods
• Product Name

Furthermore, all labels must be in Vietnamese. If your product label is in a foreign language, a supplementary Vietnamese label must be added to the device without altering the original label.

Import Regulations for Medical Devices in Vietnam

Pre-requisites for Importing Medical Devices to Vietnam

It is important to emphasize that only registered medical devices are permitted for import into Vietnam. Therefore, businesses must ensure their device is registered before proceeding with importation. Importers must have a valid Establishment License and foreign-owned companies must appoint a Local Authorized Representative (LAR) to facilitate the importation process.

The documents required for importing medical devices into Vietnam are similar to the documents necessary for registration with the inclusion of the following:

• Certificate of Conformity
• Certificate of Eligibility to Provide Warranty
• Certificate of Inspection (for in-vitro devices)

How to Import Medical Devices in Vietnam?

For medical devices, the Marketing Authorization Code (MAC) serves as sufficient authorization for both importing and selling within the country. The MAC is issued upon obtaining a Declaration of Applicable Standard or Circulation Registration Certificate.

There are special circumstances which do not require a MAC but will require an Import License instead, as detailed below:

a) Medical devices that do not have import registration numbers only for scientific research, inspection, testing, quality assessment, or training to guide the use and repair of medical devices;

b) Medical devices that do not have import circulation numbers to meet the urgent needs of epidemic prevention and control, overcoming consequences of natural disasters and disasters;

c) Medical devices that do not yet have import registration numbers for the purpose of aid or humanitarian aid; gifts and gifts to medical facilities; serving fairs, exhibitions, product displays, or introductions;

d) Medical devices that have not yet been imported for humanitarian medical examination and treatment;

e) Medical devices that do not yet have import registration numbers for use for personal medical treatment purposes, including medical devices specific to individuals or according to special diagnostic needs of medical establishments;

f) Used medical equipment that are:

– Imported for research and training purposes (not practicing on humans and not using these medical devices for diagnosis and treatment purposes);

– Temporary import and re-export for display, introduction, and participation in trade fairs and exhibitions.

Emerhub provides a certified Importer of Record (IOR) service, simplifying the importation of medical devices from start to finish. As your consignee, our team will manage logistics, handle customs clearance, and coordinate with customs officials and regulatory authorities. We can also provide warehousing solutions in Vietnam for your goods.

How to Register Medical Devices in Vietnam

Key Documents for Medical Device Registration

Importing and registering medical devices in Vietnam involves extensive documentation demonstrating compliance with local regulatory requirements. It is crucial to ensure that all documents submitted for the application are in Vietnamese. Any documents originally in a foreign language must be professionally translated before submission. The primary documents required include the following:

1. A written request for a new registration number.
2. Certificate of Satisfaction with ISO 13845 Quality Management Standards.
3. Power of Attorney of the medical device owner to the establishment.
4. Certificate of Eligibility for warranty issued by the owner of the medical device.
5. Circulation Certificate must be valid at the time of dossier submission for imported medical devices.
6. General Technical Dossiers on medical devices in accordance with ASEAN regulations (CSDT Dossiers)
7. Certificate of Confirmity

Medical Device Registration Process

Emerhub’s local experts can help you navigate the entire medical device registration process, ensuring compliance with Vietnam’s medical device industry requirements and regulations. Our product registration service includes the following steps:

1. Determine Device Classification: We’ll identify the medical device classification according to the AMDD. The classification depends on the device’s intended use as defined by the manufacturer and its level of risk to users.
2. Prepare and Submit Documentation: Our team will manage the necessary documentation and ensure it is accurately translated into Vietnamese. Applications for Class A and B medical devices will be sent to the local Department of Health, while Class C and D devices will be evaluated by the DMEC.
3. Pay the Registration Fees: Registration fees for medical device registration vary by device classification.

4. Application Review and Approval: The review period ranges from 25 to 60 days, depending on device classification. During the evaluation, officials may request additional information to support their assessments of your device.
5. Post-Registration Compliance: After approval, we will ensure continued compliance with the requirements and regulations for your medical devices. This includes adhering to label regulations, conducting post-market surveillance, and maintaining product safety and efficacy.

Looking to register your medical device in Vietnam? Fill in the form below to get in touch with our local experts!