The Government issued a new Decree to address the shortage of drugs and medical supplies in hospitals.

Medical staff operate medical equipment.

Automatically renew import licenses and circulation registration numbers, clearing up obstacles in importing medical equipment

To address the shortage of equipment due to the number of medical equipment import licenses (TTBYT) issued from January 1, 2018 to December 31, 2021 expiring on December 31, 2022 and the circulation registration number of TTBYT as in vitro diagnostic biological products issued from January 1, 2014 to December 31, 2017 expiring on December 31, 2022, while the progress of issuing new TTBYT circulation numbers is slow, not meeting the demand; Decree No. 07/2023/ND-CP stipulates: (i) The TTBYT import license issued from January 1, 2018 to December 31, 2021 shall continue to be used until December 31, 2024; (ii) The circulation registration number for medical equipment that is an in vitro diagnostic biological product that was granted 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 of medical equipment in cases of violations of regulations on medical equipment management.

Gradually move from pre-control to post-control

The Government's guiding viewpoint in the Decree determines that from 2025, the form of pre-inspection will be changed to post-inspection, the circulation number will be valid indefinitely, linked to the responsibility of the enterprise for information on medical equipment and the responsibility of management agencies in organizing inspections and examinations. From now until December 31, 2024, the Ministry of Health will focus on implementing the issuance of circulation licenses to completely replace import licenses.

At the same time, the Decree 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 can continue to be used until they are liquidated according to the provisions of law or until the product's expiry date, except for medical equipment that cannot overcome the defect that adversely affects 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.

Change management and declaration of medical equipment prices

Decree No. 07/2023/ND-CP stipulates the implementation of price listing for all medical equipment at locations prescribed by law on prices or on the Ministry of Health's electronic information portal (current regulations require declaring prices of medical equipment for all more than 200,000 types, each type has many different configurations and technical features,... causing overload for the health sector, not ensuring timely updates).

Only declare prices for medical equipment when there are unusual price fluctuations that affect 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.

Overcoming major obstacles in applying price declaration regulations in bidding: "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" is causing many difficulties for businesses and medical facilities in implementing price declaration and bidding procedures.

Change the method to overcome difficulties in determining the time of purchase and sale in the procurement and bidding process at public health facilities: Which time is it in the following steps: (1) time of making the procurement estimate, contractor selection plan; (2) time of negotiating the contract in the bidding process; (3) time of approving the contractor selection results; (4) time of signing the purchase and sale contract or (5) time of delivery and receipt of goods.

Handling of medical equipment whose registration number has been revoked

Decree No. 07/2023/ND-CP also issues regulations to resolve difficulties in handling medical equipment when the registration number is revoked, so it may cause difficulties for businesses, people, and state management agencies in implementing and handling medical equipment whose registration number has been revoked.

Amendments to regulations on export, import and temporary import and re-export of medical equipment

In order to remove difficulties in import and export and temporary import and re-export of medical equipment, Decree No. 07/2023/ND-CP amends and supplements Article 46 and Article 48 of Decree No. 98/2021/ND-CP in the following direction: The import of used medical equipment is carried out in accordance with the provisions of the law on foreign trade management; the Ministry of Health does not issue licenses to import used medical equipment.

The Government has considered issuing a Government Resolution to pilot policy mechanisms to ensure drugs, medical equipment and payment of medical examination and treatment costs under health insurance in accordance with the specific conditions of the health sector until relevant legal documents are issued.