Currently, the management of import and export of medical equipment must comply with the principles stipulated in Article 46 of Decree 98/2021 ND-CP. In some cases, medical equipment requires an import license according to regulations. In this article, let’s learn about the service fee for applying for a license to import medical equipment in Vietnam with MEDGATE .

When do I need to apply for a license to import medical equipment?

According to Clause 2, Article 46 of Decree 98/2021 ND-CP , for medical equipment that has a circulation number in Vietnam, the owner of the circulation number or the owner of the circulation number’s authorization letter can import according to demand, without quantity limit and without having to go through the Ministry of Health’s approval.

Specifically, cases requiring a license to import medical equipment according to Article 48 of Decree 98/2021 ND-CP :

• Medical equipment without a circulation number is imported only for scientific research, inspection, testing, trial, quality assessment or training on the use and repair of medical equipment;
• Medical equipment without circulation number imported to meet urgent needs for disease prevention and control, overcoming consequences of natural disasters and catastrophes;
• Medical equipment without circulation number imported for aid purposes, humanitarian aid; gifts for medical facilities; for fairs, exhibitions, displays or product introductions;
• Medical equipment without circulation number imported to serve humanitarian medical examination and treatment activities;
• Medical equipment without a circulation number imported for personal medical treatment purposes includes specific personal medical equipment or according to special diagnostic needs of medical facilities;
• Used medical equipment

List of medical equipment for import license: stipulated in Article 6 of Circular 05/2022/TT-BYT

Medical equipment and machinery used in medical examination and treatment

Procedures for applying for a license to import medical equipment

• Prepare and submit documents: Organizations and individuals requesting a license to import medical equipment complete the documents according to Clause 2, Article 48 of Decree 98/2021 ND-CP and submit them to the Ministry of Health. At the time of receiving the documents, the Ministry of Health shall issue the importer a Document Receipt Form.
• Appraisal of dossiers: When there is no request to amend or supplement the application for a license to import medical equipment, the Ministry of Health shall organize an appraisal to grant an import license within 15 working days and 02 working days for medical equipment without an import circulation number to meet urgent needs of disease prevention and overcoming the consequences of natural disasters and catastrophes, from the date of receiving a complete and valid dossier (including documents confirming payment of the appraisal fee for granting an import license according to regulations of the Ministry of Finance).
• In case the application for a license to import medical equipment is not complete, the Ministry of Health must notify the organization or individual requesting a license to import medical equipment to supplement or amend the application, specifically stating which documents and contents need to be supplemented and which need to be amended within 10 working days and 02 working days for medical equipment without an import circulation number to meet urgent needs for disease prevention and control, overcoming the consequences of natural disasters and catastrophes, from the date of receiving a complete and valid application.
• Receive results: If there are no additional or revised requirements, the Ministry of Health is responsible for granting an import license to the organization, individual requesting the import and the customs authority.

Service fee for applying for medical equipment import license

According to Circular 278/2016/TT-BTC and Circular No. 59/2023/TT-BTC effective from October 16, 2023, the Ministry of Finance stipulates the collection rates, collection, payment, management and use of fees in the health sector.

Accordingly, the fee for granting import license for medical equipment will be abolished, instead, the fee for appraisal and granting import license for medical equipment will be collected: VND 2,000,000/application.

 

To learn more about medical equipment registration and the process to issue a medical equipment circulation number at MEDGATE , please contact Hotline: 098.546.1894 or email: medgatevn@gmail.com for advice on document services, procedures, price quotes for registration, circulation announcement, and advertising of medical equipment.