The Ministry of Health does not issue licenses to import used medical equipment.

On the morning of March 10, the Ministry of Health held a Conference to guide the implementation of Decree No. 07/2023/ND-CP dated March 3, 2023 and Resolution No. 30/NQ-CP to the Departments of Health, hospitals, medical facilities and enterprises manufacturing and trading medical equipment.

The Ministry of Health stated that on March 3, the Government signed and issued Decree No. 07/2023/ND-CP amending and supplementing a number of articles of Decree No. 98/2021/ND-CP dated November 8, 2021 on medical equipment management to address existing problems, limitations, and inadequacies in medical equipment management in the recent past, gradually perfecting the state management institution on medical equipment, meeting practical requirements and international integration requirements in the field of medical equipment (TTBYT).

Deputy Minister Do Xuan Tuyen chaired the Conference (photo of Ministry of Health).

According to the Ministry of Health, the amendments and supplements in Decree No. 07/2023/ND-CP have resolved problems related to import licenses and registration numbers for circulation of medical equipment.

To address the shortage of equipment due to the expiration of import licenses for medical equipment and registration numbers for circulation of medical equipment that are in vitro diagnostic biological products, while the progress of issuing new circulation numbers for equipment has not met the needs of society, Decree No. 07/2023/ND-CP stipulates the extension of the validity of import licenses and circulation numbers for medical equipment.

Medical equipment import licenses issued from January 1, 2018 to December 31, 2021 will continue to be valid until December 31, 2024.

The registration number for medical equipment that is an in vitro diagnostic biological product issued from January 1, 2014 to December 31, 2019 will continue to be used until December 31, 2024.

Organizations that have been granted import licenses and circulation numbers for medical equipment must meet the conditions prescribed by law and are responsible for ensuring the quality, quantity, type, and purpose of use of medical equipment. The Ministry of Health will conduct inspections, checks, and revoke import licenses and circulation numbers for medical equipment in cases of violations of regulations on medical equipment management.

Decree 07 also stipulates the promotion of the issuance of registration numbers for medical equipment circulation and the removal of difficulties in the revocation of circulation numbers and the handling of medical equipment whose circulation numbers have been revoked.

From now until December 31, 2024, the Ministry of Health will focus on implementing the issuance of indefinite-term medical equipment circulation registration numbers to completely replace import licenses.

At the same time, Decree No. 07/2023/ND-CP also stipulates the post-inspection responsibilities of the Ministry of Health; adding Article 39a on the handling of medical equipment after the circulation number is revoked.

Accordingly, medical equipment sold to medical facilities or users may continue to be used until they are liquidated according to legal regulations or until the product's expiry date, except for medical equipment that cannot be repaired due to defects that adversely affect the health of users according to regulations.

In case a medical device with a circulation number is recalled but has not been sold to users or medical facilities, the owner of the circulation number is responsible for stopping the circulation of the medical device and taking measures to recall the medical device.

This Decree also amended the regulations on import and export and temporary import and re-export of medical equipment. It stipulates that the import of used medical equipment must comply with the provisions of the law on foreign trade management; the Ministry of Health does not issue licenses to import used medical equipment.

Decree 07 also amended the regulations to resolve practical difficulties in price declaration. Having overcome the difficulties in Decree No. 98/2021/ND-CP in applying the price declaration regulations in bidding, Decree No. 07/2023/ND-CP abolished the regulation "Medical equipment must not be purchased or sold without a declared price and must not be purchased or sold at a price higher than the declared price on the Ministry of Health's Electronic Information Portal at the time of purchase and sale" due to many difficulties and problems for businesses and medical facilities during the implementation process.

Decree No. 07/2023/ND-CP stipulates: Price declaration for medical equipment is only required when there are unusual price fluctuations affecting the supply of medical equipment, the ability of buyers to pay, and the ability of the Health Insurance Fund to pay.

The Minister of Health shall promulgate, update, amend and supplement the list and information content of medical equipment for which prices must be declared. The content, form and procedures for declaring prices of medical equipment shall comply with the provisions of law on prices or on the Ministry of Health's electronic information portal.

According to experts, Decree No. 07/2023/ND-CP was issued to promptly resolve urgent issues in the procurement of medical equipment, promptly meet supply, and resolve congestion due to backlog of imported medical equipment at border gates.

Decree No. 07/2023/ND-CP is the basis for businesses trading, manufacturing, and supplying medical equipment, and managers at all levels, leaders of hospitals and medical facilities to clearly define their responsibilities, powers, and obligations in order to contribute to providing the health sector with quality equipment, at the right value, and used effectively to serve the work of protecting and caring for people's health.

The Ministry of Health assigns responsibility to relevant units of the Ministry of Health to organize implementation and issue guiding documents to unify implementation throughout the industry in accordance with Government regulations.

Source: https://www.congluan.vn/bo-y-te-khong-cap-giay-phep-nhap-khau-trang-thiet-bi-y-te-da-qua-su-dung-post238661.html