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Vietnam to Require Annual Inspection of Certain Medical Equipment
Published on: January 15th, 2021
On December 31st, 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:
- Anesthesia Machines
- Electrical Surgical Units (ESU)
- Infant Incubators
- Dialysis Machines
This regulation will be in effect from March 1st, 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 1st, 2021, ventilators, anesthesia machines, and ESUs will be subject to the requirements annually starting at time of purchase. For medical devices purchased after September 1st, 2021, a safety inspection and technical performance evaluation will be required. If purchased before this date, operators will have an extended deadline of December 31st, 2022 to meet the inspection and evaluation requirements.
Starting September 1st, 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 1st, 2022, a safety inspection and technical performance evaluation will be required. If purchased before this date, operators will have an extended deadline of December 31st, 2023 to meet the inspection and evaluation requirements.
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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in Vietnam. Contact Asia Actual today with any questions or to see how this will affect your product portfolio.