Procedure for importing medical equipment

1. Import condition

• Organization or individual who imports is the owner of circulation number or has authorization of the circulation number owner. When the circulation number owner authorizes import facility to import medical equipment, it must send the authorization to the Ministry of Health and Customs Office concurrently.
• Organization or individual who imports must have warehouse which complies with the requirement pursuant to Clause 3 Article 13 of Decree No. 36/2016/ND-CP; and must have transport vehicle which complies with the requirement pursuant to Clause 4 Article 13 of Decree No. 36/2016/ND-CP; or must have a contract with facility having sufficient ability to preserve and transport medical equipment.

2. Dossier and procedure for granting the import license

* Dossier

• Application for granting the import license pursuant to form No. 08 as specified in Annex I enclosed with Decree No. 36/2016/ND-CP.
• Document summarizes technology of medical equipment pursuant to form as specified in Annex VIII enclosed with Decree No. 36/2016/ND-CP; and user manual of that medical equipment.
• The Certificate of Managing Quality Standard of medical equipment manufacturing facility applying for the import license.
• In case of importing for researching purpose, the applicant must have a certified copy of the approving decision of research purpose for research topic; and document proving that the  product to be imported was approved for using by competent authority in the exporting country.
• In case of importing for  training purpose, the applicant must have the original of training program; and document proving that the product to be imported was approved for using by competent authority in the exporting country.
• In case of importing for aiding purpose, the applicant must have a copy of approving decision for receiving aid of competent authority and document proving that the product was permitted by the competent authority in the exporting country.
• In case of importing for using purpose for the individual healthcare: specified document of doctor fits with diseases of individual applying for the import license.

* Procedure

• The applicant who imports medical equipment sends the dossier to Ministry of Health. After receiving the dossier of applying for the medical equipment import license, the Ministry of Health must send the applicant the dossier receipt pursuant to form No. 06 as specified in Annex IV enclosed with Decree No. 36/2016/ND-CP.
• In case of having no request for amendment, supplement the dossier of applying for medical equipment import license, within fifteen working days from the date noted in the dossier receipt, the Ministry of Health shall appraise and  grant the medical equipment import license.
• In case of the dossier of applying for the medical equipment import license isn’t valid within five working days from the date noted in the dossier receipt, the Ministry of Health must have notification for organization or individual who applies for the medical equipment import license to amend and supplement dossier. The notification must specify the content which is needed to be amendment or supplement.
• Upon the receipt of the notification, the applicant must comply accordingly.  The submission date of the amended and supplemented dossier shall be recorded in the initial document receipt. If such amendment and supplementation are not sufficient, the MOH shall continue to request for amendment and supplementation. If the newly submitted dossier is valid the MOH shall grant the license to the applicant and send an extra copy to customs agency.

3. Procedure of importing medical equipment

• Clause 3 Article 41 of Decree No. 36/2016/ND-CP regulates that the procedure of importing medical equipment must comply with the provisions of the customs legislation.
• The customs dossier includes:

+ Customs application or the equivalent pursuant to form HQ/2015/NK enclosed with Circular No. 38/2015/TT-BTC.

+ Relevant documents: Commodity sale contract, transport Certificate,  certificate of origin of commodity, Import License, notification of exemption from inspection or exemption from specialized inspection, other relevant certificates relating good.

+ Authorization document (in case of authorizing another organization or individual to carry out the customs procedure)

+ Submitted document can be in paper or electronic form. Electronic document must warrant the integrity and format in accordance with the law on electronic transactions.

• Organization or, individual who imports medical equipment shall submit and present the customs dossier to Customs agency. Organization or individual submits the dossier before the date that commodity to border gate or within thirty days from the date of arrival of commodity.
• When carrying out customs procedure, the applicant has responsibility for:

+ Declaring and submitting the customs application; submitting or presenting document of the customs dossier.

+ Bringing commodity, and transport vehicle to location specify to make reality inspection,

+ Paying taxes and performing other financial obligations in accordance with the law on taxes, fees, charges and other provisions of relevant laws.

• When carrying out customs procedure, Customs Office and, customs officer have responsibilities for :

+ Receiving and registering the customs dossier.

+ Checking the customs dossier and checking actual commodity, and transport vehicle.

+ Organizing for collecting taxes and other revenues in accordance with the law on taxes, fees, charges and other provisions of relevant laws.

+ Making decision of commodity clearance, and liberation and confirming that transport vehicle has accomplished customs procedure.

• After the applicant has fulfilled all requirement to carry out customs procedure the Customs officer completes the inspection of the customs dossier no more than two working hours from the time that Customs Office receives enough the customs dossier; completes the inspection of actual commodity no more than 8 working hours from the time that the applicant presents enough merchandise for customs office.
• The clearance of commodity will be carried out after completing customs procedure.