Government issues a new decree to remove existing barriers on medical device management

On March 3, 2023, the government issued Decree No. 07/2023/NĐ-CP to amend and supplement some articles of Decree No. 98/2021/NĐ-CP dated November 8, 2021, regarding the management of medical equipment (ME) to address existing limitations and shortcomings in the management of medical equipment in recent times

1. Automatic extension of import licenses and circulation registration numbers

Decree No. 07/2023/NĐ-CP stipulates that organizations that have been granted medical equipment import licenses and circulation registration numbers must meet the conditions prescribed by law and be responsible for ensuring the quality, quantity, type, and intended use of medical equipment.

The Ministry of Health will inspect, check, and revoke medical equipment import licenses and circulation registration numbers for cases of violation of medical equipment management regulations.

Vinacontrol provides safety inspection services and technical features for ME under Decree No. 98/2021/NĐ-CP.

2. Transition from pre-inspection to post-inspection

From 2025, circulation registration numbers will have unlimited validity and will be linked to the responsibility of businesses for ME information and the responsibility of management agencies in organizing inspections and transitioning from pre-inspection to post-inspection. From now until December 31, 2024, the Ministry of Health will focus on implementing circulation registration licensing to completely replace import licenses.

In addition, Decree 07 also stipulates the responsibility of the Ministry of Health in post-inspection and supplements regulations on handling ME after revoking circulation registration numbers.

3. Changes in ME management, price declaration

According to the regulations of Decree No. 07/2023/NĐ-CP, ME will only declare prices when there are abnormal fluctuations in prices that affect the supply of ME, the ability of buyers to pay, and the payment capacity of the Health Insurance Fund.

The Ministry of Health also issues, updates, amends, and supplements the list and content of ME information that must be declared.

These regulations have addressed major obstacles in price declaration in bidding under Decree No. 98/2021/NĐ-CP.

4. Handling of ME with revoked circulation registration numbers

Decree No. 07/2023/NĐ-CP has issued regulations to address difficulties in handling ME with revoked circulation registration numbers.

5. Modifies the regulations on import and temporary importation and re-export of medical equipment

The Decree 07/2023/NĐ-CP also modifies the regulations on import and temporary importation and re-export of medical equipment. Specifically, the importation of used medical equipment shall be carried out under the laws on foreign trade management. The Ministry of Health shall not issue import licenses for used medical equipment.