Medical Device Import Registration in Vietnam: 3 Questions to Answer?

 Medical device includes device related to human health, therefore, the business of medical device in the conditional business line in accordance with the law of Vietnam. Hence the medical device import registration in Vietnam has to follow certain procedures.

Why medical device import registration in Vietnam is important?

Medical device is defined as kinds of device, tools, materials for implanting activities, reagents and in vitro calibration solutions, software which are used separately or in association with each other according to the instruction of their owners for human use for the purpose of diagnostic, prevention, supervision, treatment and elimination the illness or to making up for pains.

Medical device import registration in Vietnam is of paramount importance for several key reasons:

Regulatory Compliance: Vietnam has stringent regulations governing the importation and distribution of medical devices. Medical devices play a critical role in healthcare, and ensuring their safety and efficacy is a top priority. Import registration helps ensure that medical devices entering the Vietnamese market meet the necessary quality and safety standards.

Patient Safety: Medical devices directly impact patient health and well-being. Import registration helps verify the quality, performance, and safety of these devices, reducing the risk of substandard or unsafe products reaching patients. This safeguards the health and safety of the Vietnamese population.

Quality Assurance: Medical device import registration in Vietnam requires manufacturers and importers to adhere to established quality control processes and standards. This promotes the availability of high-quality medical devices in Vietnam, contributing to better patient outcomes and healthcare delivery.

Traceability: Medical device import registration in Vietnam establishes a clear record of medical devices entering the country. This traceability aids in product recalls, monitoring adverse events, and tracking the supply chain, ensuring swift responses to any issues or safety concerns that may arise.

Accountability: Medical device import registration in Vietnam holds manufacturers and importers accountable for the medical devices they introduce to the Vietnamese market. It provides a legal framework for addressing non-compliance, fraud, or unethical practices, ensuring that those responsible are held liable.

Public Confidence: A robust import registration process enhances public trust in the healthcare system. When patients and healthcare providers can rely on the quality and safety of medical devices, it fosters confidence in the healthcare industry as a whole.

Legal Requirement: Importing and distributing medical devices without proper registration is illegal in Vietnam. Violating these regulations can result in fines, product confiscation, and even legal action. Compliance with import registration requirements is, therefore, mandatory.

Market Access: Without proper medical device import registration in Vietnam, businesses cannot access the Vietnamese medical device market, which is a growing and lucrative sector. Registering allows companies to tap into this market and expand their business opportunities.

In summary, medical device import registration in Vietnam serves as a critical safeguard to protect public health, ensure the quality and safety of medical devices, and maintain the integrity of the healthcare system. It is a legal requirement that businesses must adhere to in order to participate in this important sector of the Vietnamese economy.

What is Medical Device Import Registration in Vietnam?

Medical device classification: 

For medical device import registration in Vietnam, first of all, the enterprise should classify medical device.

Medical device circulated in Vietnam will be classified based on the level of potential risks associated with the technical design and manufacture of such medical device.

Pursuant to Decree No.36/2016/ND-CP on medical device management, medical device shall be classified into the following 2 groups which are divided into 4 types as follows:

– Type 1 comprises Type A medical device which is medical device with low level of risks.

– Type 2 comprises Type B, C and D medical device, where

+ Type B medical device is medical device with lower average level of risks;

+ Type C medical device is medical device with upper average level of risks;

+ Type D medical device is medical device with high level of risks.

In case medical device can be classified into two or more levels of risk, the classification by the highest risk level of such medical device shall be applied.

The classification of medical device must be conducted by qualified organizations as provided by law.

In addition, the law of Vietnam recognizes the results of classification of medical device made by competent regulatory body in other countries such as Korea, Japan, … on the basis of international treaties or international arrangements to which Vietnam is a party or of a country which adopts a medical device classification system similar to that adopted by Vietnam.

Declaration of standards:

After classifying medical device, the enterprise shall declare applicable standards for Type A medical device or issue certificate of free-sale registration for Type B, C, D medical device.

This procedure makes sure that medical device which the enterprise has trading requirements, is allowed to be distributed in Vietnam.

Other requirements:

With the exception of medical device of type A, in order to directly sell medical device to consumers, the enterprise needs to ensure the staffing requirements as well as the material facility requirements in accordance with the law, for instance:

Trading premise must have technically qualified staffs to perform the installation and use instructions suitable to the medical device which the establishment buys and sells, including at least one qualified technical staff specialized in technical or medical or pharmaceutical medical or technical colleges of medical device or higher or college or higher degree, whose specialized training is appropriate to the type of medical device that the establishment purchase.

Trading premise needs to prepare the warehouse which has area in accordance with the type and the quantity of the medical device to be stored. The warehouse should be airy, dry, clean, separated from sources of pollution and satisfied with other storing requirement device according to its manual.

In addition, trading premise shall have suitable transportation vehicles for delivering of medical devices from trading premise to received place. In case there are no storage facilities or transport means, a contract with an establishment satisfying requirements for storage facilities and transport of medical device shall be concluded.

How to navigate the medical device import registration in Vietnam regulatory landscape?

A law firm in Vietnam can play a crucial role in assisting businesses with the complex process of medical device import registration in Vietnam. Importing medical devices into the Vietnamese market involves strict regulatory compliance and adherence to various legal requirements, making legal expertise indispensable in this domain.

Firstly, a reliable law firm specializing in healthcare and regulatory matters can help clients understand the intricacies of the medical device import registration in Vietnam. They can provide detailed guidance on the specific requirements, documentation, and procedures necessary for obtaining the necessary approvals from the relevant authorities.

One of the key services that a law firm can offer is helping clients classify their medical devices according to the Vietnamese regulations, ensuring that they are categorized correctly as Type A, B, C, or D medical devices. This classification is a critical step, as it determines the subsequent registration requirements and standards that must be met. The law firm can also assist in evaluating whether the results of classification from other countries can be recognized in Vietnam based on international treaties or arrangements.

Furthermore, the law firm can support clients in preparing and submitting the required documentation for medical device import registration in Vietnam. This includes preparing applications, compiling technical dossiers, and ensuring that all documents are complete and accurate. They can liaise with regulatory authorities on behalf of the client to facilitate the registration process, helping to navigate any potential challenges or inquiries that may arise.

Additionally, a law firm can advise clients on compliance with staffing and facility requirements, ensuring that the trading premises, warehouses, and transportation vehicles meet the legal standards set by Vietnamese authorities. They can assist in drafting contracts with third-party establishments that may be involved in storage and transportation if needed.

A law firm in Vietnam specializing in medical device import registration in Vietnam can provide invaluable legal support and guidance throughout the entire process. Their expertise in navigating the regulatory landscape, ensuring compliance, and facilitating interactions with regulatory authorities can help businesses successfully bring their medical devices to the Vietnamese market while minimizing risks and delays.

About ANT Lawyers, a law firm in Vietnam

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers has lawyers in Ho Chi Minh city, Hanoi,  and Danang, and will help customers in doing business in Vietnam.