Latest procedures for importing medical equipment into Vietnam

Importing goods, especially medical equipment, into Vietnam needs to comply with strict regulations. What is the process for importing medical equipment? What steps does the procedure for importing medical equipment include? Medgate will answer the above questions in the article below.

Legal basis for importing medical equipment

Procedures for importing general goods and medical equipment when they want to circulate into the Vietnamese market need to comply with specific regulations issued by management agencies. That is Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP and was issued on March 3, 2023.

Latest regulations on import procedures for medical equipment

Licensing documents for medical equipment import license

According to the provisions of Clause 2, Article 48 of Decree 98/2021/ND-CP and amending and supplementing this content in Clause 12, Article 1 of Decree 07/2023/ND-CP, the application for licensing import of equipment Medical equipment includes the following documents:

1. Application for import license.

2. Document summarizing the technical parts of the medical equipment, this document requires Vietnamese.

3. Certificate of compliance with quality management standards of the medical equipment manufacturer, including confirmation from the agency or individual requesting the import license.

4. In case of import for research purposes, there is a need to have a certified copy of the decision approving the research topic and documents proving that the medical equipment requested to be imported has been approved. Authorized organizations allow circulation. And this certificate requires confirmation from the organization or agency requesting the import license.

5. For import for training purposes, it is necessary to submit the original training program and documents proving that the medical equipment requested to be imported has been permitted for circulation by competent authorities. Similarly, this document also requires confirmation from the organization or individual requesting the import license.

6. For medical equipment that does not have a circulation registration number, imported for use at medical examination and treatment facilities purchased from official development support sources (ODA) and preferential loans, hospitals Non-refundable aid is not part of official development assistance.

7. For imports for aid purposes, a certified copy of the decision approving receipt of aid from the competent authority is required. In addition, there must be documents proving that the medical equipment requested for import has been approved for circulation by the competent authority and this document is certified by this authority.

8. For imports for gift purposes to medical facilities, a certified copy showing the gift content is required. Requires documents proving from the competent authority permitting the circulation of the medical equipment requested to be imported and documents with the confirmation stamp of the agency or individual requesting the import license.

9. For import to serve humanitarian medical examination and treatment activities, it is necessary to request documents proving that the medical equipment requested for import has been licensed for circulation from a competent authority with confirmation from the competent authority. Agency requesting import license.

10. For import for special diagnostic needs at medical examination and treatment facilities, additional documents are required to prove that the medical equipment requested to be imported has been approved for circulation by a competent authority. . Similarly, this document requires confirmation from the organization or individual applying for the import license.

11. In case of import for personal medical treatment purposes, including medical equipment specific to the individual, request to submit a copy of the doctor’s prescription corresponding to the illness of the individual requesting the import license. .

12. In case of import for the purpose of display, fairs, exhibitions or product introduction, additional copies of program documents, invitations and contracts for display performance are required. exhibition.

13. In case of import to meet urgent needs such as disease prevention, natural disaster recovery, the following additional documents are required:

+ Approval issued by a competent authority for urgent needs.

+ Documents proving that medical equipment is allowed by a competent authority to be circulated or used for emergency purposes.

+ Documents need to be confirmed by the individual or organization requesting the import license.

14. In case of import as prescribed in Clause 6, the application for an import license requires the following additional documents:

+ Decision approving investment policies, investment decisions (in case of investment projects) or decision approving project documents (in case of technical assistance projects, project costs or aid non-refundable aid and not part of official development assistance) original or notarized copy. This decision needs to clearly state the content of import of medical equipment.

+ Original or notarized copy of the contract to provide medical equipment for the project.

+ Authorization letter from the owner of the medical equipment to the agency or individual requesting the import license and this authorization must be valid at the time of application submission. The facility requesting an import license shall submit the original or a consularly legalized copy.

+ Documents confirming warranty eligibility provided by the medical equipment owner, unless the medical equipment does not have a warranty or is only used once according to the regulations of the medical equipment owner. This document requires submission of the original or a consularly legalized copy.

+ Medical equipment circulation certificate is still valid at the time of submitting the consular legalized application (original or notarized copy).

Cases requiring a license to import medical equipment

According to the provisions of Clause 1, Article 48 of Decree 98/2021/ND-CP, a medical equipment import license is required in the following cases:

Medical equipment that does not have a circulation registration number is imported for the purpose of research, inspection, testing, testing, quality assessment or training for instructions on the use or repair of medical equipment.
Medical equipment that does not have a circulation registration number is imported to serve urgent needs in disease prevention or overcoming consequences left by natural disasters and catastrophes.
Medical equipment that does not have a circulation registration number is imported to serve the purpose of aid, support humanitarian activities, donate to medical examination and treatment facilities, serve fairs, exhibitions, displays or presentations. product introduction.

Medical equipment without a circulation number imported for the purpose of individual medical treatment includes medical equipment specific to the individual or according to the special diagnostic needs of the medical examination and treatment facility.

Used medical equipment is imported for research and training purposes or temporarily imported and re-exported for display, introduction, or use in exhibitions or fairs.

Above are the procedures for importing medical equipment into Vietnam. If you still have questions about procedures as well as learn about medical equipment import services , contact   Medgate  at Hotline:  098.546.1894 or Email: medgatevn@gmail.com for free consultation.