On December 31^st, 2020, the Ministry of Health (MoH) issued Circular No. 30/2020 providing a list of medical equipment subject to annual safety inspections and technical capability assessments, along with the timelines for implementation.

Equipment categories effected by this announcement include:

1. Ventilators
2. Anesthesia Machines
3. Electrical Surgical Units (ESU)
4. Infant Incubators
5. Defibrillators
6. Dialysis Machines

This regulation will be in effect from March 1^st, 2021.

The safety inspection can be conducted by any entity that is certified by the MoH, such as Vina Control and the Medical Devices Institute. This Circular applies to government and private hospitals in particular, so they should be sure to have their inspections done before using the specified medical devices.

Phases of Implementation

Starting September 1^st, 2021, ventilators, anesthesia machines, and ESUs will be subject to the requirements annually starting at time of purchase. For medical devices purchased after September 1^st, 2021, a safety inspection and technical performance evaluation will be required. If purchased before this date, operators will have an extended deadline of December 31^st, 2022 to meet the inspection and evaluation requirements.

Starting September 1^st, 2022, infant incubators, defibrillators, and dialysis machines will be subject to the requirements annually starting at time of purchase. For medical devices purchased after September 1^st, 2022, a safety inspection and technical performance evaluation will be required. If purchased before this date, operators will have an extended deadline of December 31^st, 2023 to meet the inspection and evaluation requirements.