Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on medical equipment management

On March 3, 2023, the Government issued Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP dated November 8, 2021, on medical equipment management to solve the problem. Resolve the shortcomings, limitations, and inadequacies in medical equipment management recently. In the following article, Viet An Law will summarize new points of Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on medical equipment management that need to be noted.

Basic information of Decree 07/2023/ND-CP

• Symbol number: 07/2023/ND-CP
• Date of issue: March 3, 2023
• Effective date: March 3, 2023
• Document type: Decree
• Issuing agency: Government
• Signed by: Tran Hong Ha

New points of Decree 07/2023/ND-CP on medical equipment management

Decree 07/2023/ND-CP was issued, amending and supplementing the following new contents:

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

• Medical equipment import licenses issued from January 1, 2018, to December 31, 2021, will continue to be used until December 31, 2024.
• Circulation registration numbers for medical equipment that are in vitro diagnostic biological products issued from January 1, 2014, to December 31, 2019, can continue to be used until December 31, 2024.

In the light of the above regulations, favorable conditions have been created for the use of import licenses and circulation registration numbers, clearing obstacles in importing medical equipment, specifically:

• Promote the issuance of registration numbers for the circulation of medical equipment and remove difficulties in revoking circulation numbers and handling medical equipment whose circulation numbers have been revoked;
• Amend regulations on import and export and temporary import and re-export of medical equipment;

Change management, listing, and price declaration of medical equipment

• Decree 07/2023/ND-CP regulates the implementation of price listing for all medical equipment at locations specified by price law or on the Electronic Information Portal of the Ministry of Health. This content has overcome the shortcomings of current regulations when requiring medical equipment prices to be declared for more than 200,000 types, each type has many different configurations and technical features, … causing overload for the health sector, and not ensuring timely updates.
• In addition, Decree 07/2023/ND-CP abolishes the regulation “Purchase medical equipment without a declared price or with higher prices than the declared price on the Electronic Information Portal of the Ministry of Health at the time of purchase is not allowed“.
• Regulations: Only declare prices for medical equipment when unusual price fluctuations are affecting the supply of medical equipment, the buyer’s ability to pay, and the Fund’s ability to pay. Health Insurance. The Minister of Health promulgates, updates, amends, and supplements the list and information content of medical equipment that must declare prices.

Handling of medical equipment has been revoked circulation registration number

Decree 07/2023/ND-CP also stipulates resolving problems in handling medical equipment when its circulation registration number is revoked, which can cause difficulties for businesses, people, and state management agencies in the implementation and handling of medical equipment whose circulation registration numbers have been revoked can easily cause other consequences for society.

Therefore, the provisions in Clause 8, Article 1 of Decree 07/2023/ND-CP on handling medical equipment after revoking the circulation number have added Article 39a to Decree 98/2021/ND-CP as follows:

• Medical equipment sold to medical facilities or users may continue to be used until liquidated according to legal regulations or until the product’s shelf life expires, except for medical equipment practically impossible to fix the error factor that adversely affects the user’s health.
• In case medical equipment has a circulation number that 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 equipment and taking appropriate measures to recall medical equipment.

Amend regulations on import and export and temporary import and re-export of medical equipment

To solve the shortage of equipment, Decree 07/2023/ND-CP stipulates the extension of the validity of import licenses and circulation numbers of medical equipment:

• Medical equipment import licenses issued from January 1, 2018, to December 31, 2021, will continue to be used until December 31, 2024;
• Circulation registration numbers for medical equipment that are in vitro diagnostic biological products issued from January 1, 2014, to December 31, 2019, can continue to be used until December 31, 2024.
• Organizations that have been granted a license to import and circulate medical equipment must meet the conditions prescribed by law and must be responsible for ensuring the quality, quantity, type, and purpose use of medical equipment.
• The Ministry of Health will inspect, examine, and revoke import licenses and circulation numbers of medical equipment for cases of violation of regulations on medical equipment management.

In addition, Decree 07/2023/ND-CP also amends regulations on import and export and temporary import and re-export of medical equipment. Specifically, amending and supplementing Article 46 and Article 48 of Decree 98/2021/ND-CP: The import of used medical equipment is carried out following the provisions of the law on foreign trade management; The Ministry of Health does not issue licenses to import used medical equipment.

Dossiers for import licenses for medical equipment without import circulation number

According to Clause 2, Article 48 of Decree 98/2021/ND-CP (amended and supplemented in Clause 12, Article 1 of Decree 07/2023/ND-CP), the application for medical equipment import license is not yet available. The import circulation number is revised and includes the following contents:

• Original or certified copy of Decision approving investment policy and Investment decision for investment projects or Decision approving project documents for technical assistance projects, project costs, or non-refundable aid is not part of official development assistance, which clearly states the content of import of medical equipment; Original or certified copy of the contract to provide medical equipment for the project; Power of attorney from the owner of the medical equipment to the organization requesting the import license is still valid at the time of application submission.
• Certificate of warranty eligibility issued by the owner of the medical equipment, except in the case of single-use medical equipment as prescribed by the owner of the medical equipment or there is documentation proving that it is not. has a warranty; The circulation certificate is still valid at the time of submitting the application for imported medical equipment (submit the consular legalized version or a certified copy of the consular legalized version).
• In case the circulation paper is not in English or not in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of the law.

Responsibility for posting information of the Ministry of Health

Decree 07/2023/ND-CP has supplemented requirements for publicly posted content on the Electronic Information Portal under the responsibility of the Ministry of Health. Specifically includes information about:

• Winning bid price for purchasing medical equipment from State medical facilities nationwide;
• List of medical equipment whose circulation numbers have been revoked;
• List of organizations and individuals who falsify records and violate regulations on medical equipment management as prescribed in this Decree.

Compared to previous information requests, including only requesting information about the subjective price of medical equipment declared by the business; or The list of medical equipment whose circulation numbers have been revoked can only be reported in a narrow scope, the new regulations are more objective and comprehensive to help make public information clearer. This helps limit corruption and violations related to medical equipment bidding management in Vietnam.

For clients who need advice or learn more about medical equipment management as updated by Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on medical equipment management, please contact Viet An Law Firm for the best support.