“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

CDSCO Issues Updates to IVD Classification List in India

The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.

Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit

On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India's largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, "Paving the way for a USD 50 billion MedTech Industry by 2030," signifying a collective vision for the industry's future growth.

Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS

On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect.  A translated version of the document is available on Asia Actual’s website here.  All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.