EXPORTING MEDICAL DEVICES INTO VIETNAM

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1. Overview

Medical equipment is specified in Article 2, Decree 98/2021/ND-CP, as follows:

1.“medical device” means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:

a) The device is intended by the product owner to be used, whether separately or in combination with each other, for human beings for one or more of the following purposes:

– 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.

b) 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 in Point a of this Clause.

2. “in vitro diagnostic (IVD) medical device” means 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.

3. “personalized medical device” means a medical device that is specifically made in accordance with a duly qualified medical practitioner’s written prescription, which gives, under his responsibility, specific design characteristics and intended for the sole use of a particular individual.”

According to current regulations, all medical devices need to be classified.

Medical devices are classified into 4 categories based on the level of potential risks associated with the technical design and manufacture of such medical devices:

1. Type-A medical devices are those at low level of risks
2. Type-B medical devices are those at low-moderate level of risks
3. Type-C medical devices are those at moderate-high level of risks.
4. Type-D medical devices are those at high level of risks.

From July 1, 2022, importers must carry out procedures for announcing standards applicable to class A and B medical devices (From Articles 26 to 28 of Decree 98/2021/ND-CP on site management medical devices and Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP); and procedures for registration of circulation with class C, D medical devices (From Article 29 – Article 32 of Decree 98/2021/ND-CP and Decree 07/2023/ND-CP amending Decree 98/2021 /ND-CP).

2. Documents to be provided

Here are the documents to be provided by the manufacturer, the Vietnamese company (distributor, importer) and some notes: