Vietnam Update – 2021
Welcome to the Arazy Group Medical Device Regulatory Update! Today’s update is from Vietnam and the topics include: the update on the vietnam regulatory framework through a new decree that was issued in March 2021, but will only be enforced in October 2021. The transition period of a new regulatory framework that will be fully implemented in January 2023. The update on fast track registration procedure, and lastly, the implementation of ASEAN common submission dossier template in January 2022.
Let’s review each update in detail.
The medical device regulatory framework in Vietnam is currently under a transition process. It started with the Circular 30 that was issued in 2015. Under this circular, product registration is not required, except for certain categories that are listed in the Circular. In 2016, decree 36 was issued and all devices became subject to product registration, notification for class A, and marketing authorization for Class B, C, and D. Following the issuance of Decree 36, some existing IVD products that were previously regulated by the Drug administration of vietnam will be regulated by the department of medical equipment and construction instead.
In 2018, decree 169 was issued to amend Decree 36. Under this Decree, foreign medical device classification is no longer recognized. and so local official classification became a mandatory part of the product registration process. This classification process will be conducted by a third party and the Vietnamese translation of instruction for use will be required.
In 2020, Decree 3 was issued to amend both Decree 36 and one sixty nine. This decree stipulated that licenses issued before January 2022 will be valid only until December 2021, and ASEAN common submission dossier template will be fully implemented from January 2022.
In March 2021, a new draft was issued to unify all previous decrees. This Decree influences not only the update on the transition period for the implementation of decree 36 and 169, but also some technical details such as: the new classification rule, the registration pathway for medical devices used in an emergency situation or for individual purposes, and also fast track registration procedure. This draft will be fully implemented in October 2021.
To provide flexibility to the stakeholder in implementing a new regulatory framework, there have been some updates in the requirements. Licenses that are issued before the implementation of decree 36 and 169 will remain valid until the 31st of December 2022. The authority will require the ASEAN common submission dossier template to be submitted as part of the registration requirement starting from January 2022. While Decree 36 and one sixty nine will be fully implemented by January 2023.
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Previously, the only 2 criteria to be eligible for fast-track registration procedure were that products had been approved in at least 2 reference countries, and products had been circulated for at least 3 years within 5 years from the date of filing in Vietnam, and there was no warning regarding the quality and safety during this period. Reference countries include Japan, Canada, Australia, USA, EU members, and now also include UK and Switzerland.
Under the new decree however, 2 more criteria have been added: Products have been approved and actively marketed in at least 2 reference countries, and products are meeting urgent needs for national defense, security, epidemic prevention and control, and overcoming consequences of natural disasters and catastrophes, or having no substitutes available on the market. This procedure is applicable for any risk classification so long as meeting 1 out of 4 criteria. In most cases, the first criteria is the most commonly chosen by the applicant.
This is the structure of ASEAN Common Submission Dossier Template. It is recommended to use Vietnamese as the language for submitting CSDT. However, certain sections and or or information can also be submitted either in English or Vietnamese.
That's it for our update today! If you have any comments or questions, please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.