“Annual safety inspections and technical performance evaluations will need to be conducted for each purchase starting September 1st, 2021.”

David Vo
General Manager
Asia Actual VietNam

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

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:

  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 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.

Grow with Us

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.

Blog Posts

The flags of all the ASEAN Member countries

Expedited Market Access Now Available in Philippines

Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.

India Grants Import License Grace Period for Class A/B Devices

Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
Class A Exempt Instruments

India Issues Draft Notification for Exempting Certain Class A Medical Devices

The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.