Medical equipment import process updated in Vietnam in 2024

Are you a manufacturer or trader who wants to import medical equipment? You do not understand the specific process of importing medical equipment? Let Medgate answer your questions about the medical device import process through the following article.

What is a medical device?

Medical devices are types of equipment, tools, supplies, and in-tro diagnostic chemicals that are used individually or in combination with each other as directed by the owner of the medical equipment for the following purposes: :

  • Diagnose, prevent or monitor conditions, treat or alleviate symptoms, diseases or compensate for damage or injury.
  • Test, replace, adjust or support human anatomy and physiological processes.
  • Support or maintain longevity.
  • Control and support conception.
  • Disinfect medical equipment (including chemicals used in testing and inspection procedures).
  • Providing information for diagnosis, monitoring, and treatment through testing of samples originating from the human body.
  • Specialized transportation for medical purposes.

Medical device classification process

Medical equipment is classified into 4 groups: A, B, C, D. During the process of importing medical equipment, it is necessary to classify medical equipment. For each equipment belonging to each classification, there will be different import procedures. Companies can perform classification or go through a company that specializes in providing experienced classification services to ensure the most accurate records.

Medical equipment is classified based on the level of potential risks related to production and technical design, including 4 classifications as follows:

  • Class A medical equipment: Low risk such as tongue depressors, balls, surgical clips.
  • Class B medical equipment: Medium and low risk level such as suction machines and needles.
  • Type C medical equipment: Medium-high risk level such as ventilators and bone fixation braces.
  • Class D medical equipment: High level of risk such as heart valves, implantable defibrillators.

What is the procedure for classifying medical equipment?

Classification procedures are carried out by the facility that declares the applicable standards or registers for circulation. To classify medical equipment, businesses need to submit documents with the following documents:

  • Application from the facility declaring the standards to apply for a medical equipment classification.
  • Technical documents that describe the functions and technical specifications of medical equipment.
  • The standard published by the manufacturer applies.
  • Certificate of compliance with medical equipment quality management standards.
  • The position is freely circulated.
  • Details of documents that need to be submitted are specified in Decree 98/2021/ND-CP.

What does an application for a license to import medical equipment include?

According to Clause 2, Article 48 of Decree 98/2021/ND-CP, documents that need to be submitted in the application for a license to import medical equipment include:

  • Application form from the facility applying for a license to import medical equipment.
  • The document describes the technical summary of medical equipment (in Vietnamese language).
  • Certificate of compliance with quality management standards of the medical equipment manufacturer with confirmation from the agency, organization or individual requesting the import license.
  • In case of importing medical equipment for research purposes, it is necessary to submit a certified copy of the decision approving the research topic and have documents proving that the medical equipment to be imported is allowed for circulation by a competent management agency. (with confirmation from the agency requesting the medical equipment import license).
  • In case of importing medical equipment for training purposes, it is necessary to submit the original training program and documents proving that the medical equipment is authorized for circulation by a competent authority (with confirmation from the requesting agency). medical equipment import license).
  • Medical equipment without a circulation number imported for use at medical facilities purchased from official development assistance sources (ODA) and preferential loans, non-refundable aid is not considered part of the support. official development.
  • In case of import for aid, a copy of the decision approving receipt of aid from the competent authority and documents proving that the medical equipment is allowed for circulation by the management agency (confirmed by the requesting agency) is required. issuance of import license). In this case, the following additional documents are required:
    + Original or certified copy of Decision approving investment policy and Investment decision for investment projects, or Decision approving project documents for Technical assistance projects, project costs, or non-refundable aid that are not part of official development assistance, clearly stating the content of import of medical equipment.
    + Original or certified copy of contract to provide medical equipment for the project.
    + Power of attorney from the owner of the medical equipment to the facility requesting the import license is still valid at the time of submitting the import license application (HPHLS or submitting a certified copy).
    + Certificate of warranty eligibility issued by the owner of the medical equipment, except in cases where the medical equipment is only used once according to that owner’s regulations or there is documentation proving that there is no warranty.
    Submit the HPHLS or a certified copy.
    + Certificate of circulation (must be valid at the time of submitting medical equipment import application). Submit the original HPHLS or a certified copy. In case there is no English or Vietnamese version of the circulation certificate, translation into these two languages ​​is required (notarized translation).
  • In case of importing medical equipment as a gift or donation to a medical facility, it is necessary to supplement a copy of documents showing the content of the donation and the medical equipment document that has been approved for circulation by a competent authority (confirmation). of the establishment submitting the import dossier).
  • In case of importing medical equipment to serve humanitarian medical examination and treatment activities, it is necessary to supplement documents proving that the medical equipment has been authorized for circulation by a competent authority (with confirmation from an organization or individual). application for import license).
  • In case of import for special diagnostic needs of a medical facility, it is necessary to supplement documents proving that the medical equipment has been authorized for circulation by a competent authority (with confirmation from an organization or individual). request for import license).
  • In case of import for personal medical treatment purposes, including personal medical equipment, a doctor’s prescription document (copy) appropriate to the disease of the requesting individual is required. import.
  • In case of import to serve fairs, exhibitions, displays or product introductions, copies of program documents, invitations and implementation contracts are required.
  • In case of import to meet urgent needs of disease prevention and control, overcoming the consequences of natural disasters, the following documents need to be supplemented:
    + Approval document from the competent authority for urgent needs in disease prevention and overcoming the consequences of natural disasters and catastrophes;
    + Documents proving that the medical equipment has been authorized for circulation or emergency use by a competent authority, with confirmation from the organization or individual requesting the import license.

Procedures to follow when importing medical equipment

Step 1: Apply for an import license (mentioned above).

Step 2: Submit documents at customs.

Step 3: Complete customs procedures for medical equipment for customs clearance.

Above are the procedures for importing medical equipment . We hope that readers here will have an overview of the medical equipment import process and follow the regulations. To learn about document services related to import and export of medical equipment, contact Medgate immediately via Hotline: 098.546.1894  or send to Email:  medgatevn@gmail.com  for Medgate to receive advice. 

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