It is important to understand that a product is considered as a medical device if:
Firstly: A product line may be classified as a medical device if it is an instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets simultaneously the requirements including: (i) It is intended, by the product owner, to be used, whether alone or in combination, for human beings for one or more the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception, disinfection of medical devices; providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body. And (ii) The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned above.
Secondly: A product line may be classified as a medical device if it is an in vitro diagnostic (IVD) medical device such as a reagent, calibrator, control material, instrument, apparatus, equipment or system or other product, whether used alone or in combination, intended by the product owner, to be used in vitro for the examination of specimens derived from the human body.
Based on these definitions, individuals and organizations intending to engage in activities involving such products should carefully study the technical documentation, characteristics, and features of the product to accurately determine the product type and identify the relevant legal framework applicable to their activities. Currently, such activities are primarily governed by Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on the management of medical devices (“Decree 98”), as amended and supplemented by Decree No. 07/2023/ND-CP dated March 3, 2023 (“Decree 07”), and Decree No. 04/2025/ND-CP dated January 1, 2025 (“Decree 04”), along with various Circulars which guiding the classification of medical devices, etc.
So, what are the activities related to medical devices?
According to Decree 98 and its amendments, activities related to medical devices include: classification of medical devices; manufacturing, clinical research, placement on the market, trading, import, export and provision of services related to medical devices; medical device information and advertising; management of prices of medical devices, and management and use of medical devices in health facilities.
Among the above activities, some of which can be carried out by organizations or individuals, while some others due to their management nature, which can only be in charge by competent state agencies or specific authorized entities. Examples include clinical research, pricing management and medical device management and use within healthcare facilities.
For the activities which are acceptable to be operated by the traders in the medical device field, legal requirements and procedures vary depending on the nature of each activity. This includes conditions to be met, licenses required prior to operation, and the specific rights and obligations involved. Therefore, each organization or individual must clearly define their intended scope of operation, identify the relevant legal basis, and ensure compliance with the applicable regulations to minimize legal risks.
This article provides foundational legal insight into the criteria for determining whether a product falls within the definition of a medical device under current regulations. It further clarifies the scope of activities subject to legal governance in the field of medical devices, thereby enabling organizations and individuals to accurately define their intended operations. Based on this, relevant parties can identify and apply the appropriate legal provisions to ensure regulatory compliance and mitigate potential legal risks.
Date written: 20/08/2025
Disclaimers:
This article is for general information purposes only and is not intended to provide any legal advice for any particular case. The legal provisions referenced in the content are in effect at the time of publication but may have expired at the time you read the content. We therefore advise that you always consult a professional consultant before applying any content.
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