At present, the importation of medical devices is growing rapidly. However, due to the special nature of these products, the importation process is relatively complex. The below article by NPLaw provides essential information on medical device imports and answers some frequently asked questions in such a sector.

I. What is the importation of medical devices?

Under Article 28 of the Commercial Law 2005, importation is defined as bringing goods into Vietnamese territory from foreign countries or from special zones within Vietnam considered separate customs areas under the law.

Thus, importing medical devices refers to bringing medical devices into Vietnamese territory from abroad or from designated customs zones as prescribed by law.

II. Prohibited cases of medical device importation

Prohibited importation refers to a legal measure imposed by competent State authorities that prevents goods from entering the domestic market from a separate customs area or Vietnamese territory from abroad.

Currently, medical devices are not generally classified as prohibited goods for imports, so importation procedures may proceed under the applicable law.

However:

  • Subsection 4, Section 2, Appendix I of Decree 69/2018/NĐ-CP lists used medical devices as prohibited imports.
  • Article 3 of Circular 12/2018/TT-BCT specifically prohibits importing used consumer goods, including used medical devices and equipment, under the corresponding HS codes.

Categories of prohibited used medical devices include:

  • Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments (HS 9018)
  • Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus. (HS 9019)
  • Other breathing appliances and gas masks, excluding protective masks having neither mechanical parts nor replaceable filters. (HS 9020)
  • Orthopaedic appliances; including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and others which are worn, carried or implanted in the body to compensate for a defect or disability. (HS 9021)
  • Apparatus based on the use of Xrays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, Xray tubes and other Xray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like. (HS 9022)

Such a list is based on the Vietnamese Export and Import Goods List. The main principles for using the list are as follows:

  • If only a 2-digit code is listed, all 8-digit codes belonging to this Chapter are prohibited from importation.
  • If only a 4-digit code is listed, all 8-digit codes belonging to such a 4-digit group are prohibited from importation.
  • If only a 6-digit code is listed, all 8-digit codes belonging to such a 6-digit subgroup are prohibited from importation.
  • If the list is detailed in goods with the 8-digit code, only those 8-digit codes are prohibited from importation.
  • For used consumer goods prohibited from import, used spare parts and components (if any) of those goods are also prohibited from import.

Therefore, businesses must carefully review the prohibited list to avoid legal violations before importing medical devices.

III. Common questions about medical device importation

1. Can a business import medical devices with authorization from the registration certificate holder?

Under Point a, Clause 2, Article 47 of Decree 98/2021/NĐ-CP:

  • An organization or individual importing medical devices must either be the registration certificate holder or have written authorization from the holder, which must also be submitted to both the issuing authority and the customs office.

However, the importer must also meet other conditions specified in Points b and c, Clause 2 of the same article.

2. Is Ministry of Health approval required for medical devices with existing registration numbers in Vietnam?

Clause 11, Article 1 of Decree 07/2023/NĐ-CP states:

  • Medical devices with existing registration numbers in Vietnam may be imported or exported freely, with no quantity restrictions and without Ministry of Health approval.

Thus, for such devices, businesses only need to comply with the legal procedures for importation without additional permit from the Ministry of Health.

3. Can diagnostic ultrasound machines be imported as medical devices?

According to Appendix 1 of Circular 30/2015/TT-BYT, diagnostic ultrasound machines are categorized as medical devices requiring import licenses. Therefore, businesses can import these machines following the standard procedures and documents for medical device importation.

4. Can an importer continue using its import license if the authorization is revoked?

Point c, Clause 1, Article 18 of Circular 30/2015/TT-BYT provides that an import license shall be revoked if:

  • The importing entity ceases operations or no longer has authorization from the registration holder or manufacturer and has not transferred the authorization to another entity.

Therefore, once authorization is revoked, the import license becomes invalid and can no longer be used.