Medical Device Registration Vietnam (updated 2023)

Table of Contents

Authority for Medical Device

Department of Medical Device and Constructions (DMEC) is responsible for evaluating, assessing and monitoring medical devices to help Vietnamese stay healthy and safe.

DMEC website: https://dmec.moh.gov.vn/

Medical Device Definition

Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and x-ray equipment. They differ from medicines as they generally have a physical or mechanical effect on the body or are used to measure (or monitor) the body and its functions. While the objective of these products is to help improve your health and wellbeing, it’s important to know that their use also has potential risks.

Medical devices are defined in the Decree 98/2021/ND-CP (which is amended by Decree 07/2023/ND-CP) as any of the following items for human use:

instrument
apparatus
appliance
software
implant
reagent
material or other article.

Medical devices are used to:

diagnose, prevent, monitor, predict outcomes of, treat, or ease symptoms of medical conditions
replace or enhance parts of the body
control or support conception
examine specimens from the human body.

These products play an important role in health care, so it’s important they’re safe to use and work properly.

The Department of Medical Device and Constructions (DMEC) regulates the supply of medical devices in Vietnam.

In vitro diagnostic (IVDs) are typically tests that are used to examine human samples to assist with diagnosing and managing a patient’s health. IVDs are regulated as medical devices. They include reagents, kits, calibrators, controls, laboratory analysers and software, as well as tests used at the point of care, or in the home, such as COVID-19 rapid antigen self-tests and glucose monitoring tests by diabetics.

Medical Device Classification

Medical Device Classification (non IVD)

Medical devices will be placed into one of the main classifications depending on the level of risk they pose. The higher classification level, the tougher the requirements will be.

Devices are classified by considering a number of different questions, such as:

What does the manufacturer intend the medical device to be used for?
How invasive will it be in the body (e.g. is it a bandage to be placed on the skin, or a catheter to be inserted into the body)?
Where on (or in) the body will it be used?
How long will it be used for?

Rules for classification used in Vietnam is mentioned in Circular 05/2022/TT-BYT, which is very similar to HSA Singapore, and harmonized with AMDD (ASEAN Medical Device Directive).

Risk level	Classification (s)	Examples
Low	Class A	Wheelchairs
Low to Medium	Class B	Blood pressure monitors
Medium to High	Class C	Ventilators
High	Class D	Heart valves

IVD classification

The classification of IVD medical devices is based on their intended purpose and the public health risk or personal risk that may arise from an incorrect result.

The higher the potential risk an incorrect result would pose, the higher the classification.

Examples of IVD medical devices with different classifications are summarized in the following table.

Classification (s)	Risk level	Examples
Class A	No public health risk or low personal risk.	Specimen receptacle
Class B	Low public health risk or moderate personal risk	Pregnancy kit
Class C	Moderate public health risk or high personal risk	Blood glucose self testing kit, PSA screening
Class D	High public health risk	HIV kit

Medical Device Registration Pathways:

Auditing for registration documents, especially for Self Declaration of Class A, B will be randomly performed by Department of Health/Province and DMEC.

Non-IVD Medical Devices:

Documents need to provide for registration for class A, B, C, D are quite similar. Except that class A medical devices are not required to submit Clinical Evaluation Report (CER).
Registration for class A, B is called Self-Declaration, is submitted to the Department of Health in the Province that the applicant is located.
Registration for class C, D is under the evaluation of DMEC, which will go through few rounds to get license issued.
Fast track registration is applied for Medical Devices that having CFS from reference markets: USA, Canada, EU, Japan, Australia, Korea, China (NMPA issues, mentioned in Decree 98/2021/ND-CP).

IVD Medical Devices:

Documents need to provide for registration for IVD products are more complicated, especially for reagents.
Local testing is exempted for medical devices are marketed in reference countries.
Registration for class A, B is called Self-Declaration, is submitted to the Department of Health in the Province that the applicant is located.
Registration for class C, D is under the evaluation of DMEC, which will go through few rounds to get license issued.
Fast track registration is applied for Medical Devices that having CFS from reference markets: USA, Canada, EU, Japan, Australia, Korea, China (NMPA issues, mentioned in Decree 98/2021/ND-CP).

Document Requirements

CSDT will be applied for registration submission as of 1 January 2024.

Medical Devices are imported to Vietnam market need to have sub-label which is written in Vietnamese with the mandatory contents required by Decree 43/2017/ND-CP (which is amended by Decree 111/2021/ND-CP.

Validity of License for Medical Device in Vietnam is perpetual.

Importing and Distributing: License Holder can authorize distributors who are appointed by Product Owner to import medical devices into Vietnam market, by a Letter of Authorization for Importing and Distributing.

Quality Management System

Manufacturers require ISO 13485 certification.

GDPMD has not been applied in Vietnam yet, however, to trade medical device class B, C, D, companies (distributors) need to obtain the Certificate of Eligibility for trading medical device class B, C, D.

License Transfer

License Transfer is not allowed in Vietnam for Medical Device’s License.

Change in License Holder is requested to do re-registration.

Fees

Link: Circular 278/2016/TT-BTC by Ministry of Finance

Timeline

Class A, Class B: 5 – 7 days after the submission date informed

Class C, Class D: unknown. DMEC started reviewing class C, D from September 2022 after many years submission were made, since 2017. If DMEC keeps all progress as the regulations mentioned, it will be 4 – 6 months.

Advantage for choosing an independent authorized representative

Avoid conflict of interest from local distributor
Reduced fee if direct shipment to end users
Add or change distributors as required
Professional handling of post market vigilance and license maintenance
Neutral package labeling.
Authorized applicant is well verse in regulatory requirements / comply to DMEC requirements easily without repercussion from authority