IVD Product Registration in VietNam

VietNam IVD registration is currently different for diagnostic reagents and equipment registered together as a system wish are registered as medical devices, and stand alone regents and test kits which are register as pharmaceuticals. After January 1, 2020 stand alone reagents and test kits will be registered as medical device.

New rules governing the registration of medical devices and IVDs were published on November 8, 2021 with Decree No. 98/2021. This new Decree overrules previous Decree No. 36/2016/ND-CP as amended with Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. Implementation for the new rules will begin January 1, 2022 with a 1-year transition period for documentation and some Class C and D products.

Important Documents

• Decree No. 98/2021/ND-CP – effective Jan 1, 2022
• Circular No. 30/2015/TT-BYT – effective since 2015 and will transition out by Dec 31. 2022
• Decree No. 36/2016/ND-CP–effective Jan 1, 2020 and now overruled by Decree 98/2021
• Decree No. 169/2018/ND-CP – amended Decree 36 adds fast track approval; and CSDT requirement (now overruled by Decree 98/2021)
• Decree No. 03/2020/ND-CP – amended Decree 36 details implementation process of new Rules (now overruled by Decree 98/2021)
• Circular No. 44/2014 – Drug Registration Regulation (applied to stand alone IVD test kits)

As per Circular 44, stand alone IVD reagents and kits are regulated as pharmaceuticals. Risk classification follows the four-tier system A through D. Uniquely, medical device risk classification in VietNam must be determined by a locally certified organization or person.

Classification and Grouping

The first step toward regulatory compliance in VietNam is to classify the product in accordance with its intended use and risk level. Under the previous regulations, the classification needed to be performed by a certified Classification Agent but under the new rules, the Registration Holder is permitted to classify the product.

IVD components such as reagents, controls, standards, calibrators, and control materials used in conjunction with one another as part of a system can be classified separately but in accordance with the highest level of risk for the intended end use of the combined medical device system. Products such as diluents, washing solutions, sample preparation solutions, assorted support products, supplies and aids can be registered separately in accordance with their own risk.

Product grouping is another important and unique issue of VietNamese regulations. In general, the number of applications required to cover all the models of interest will be greater in VietNam compared to most markets based on number of models, portability and risk classification.

IVD Regulatory Pathway in VietNam

Beginning January 1, 2022, all Class A and B products will require a Market Authorization (MA) License. Class A and B devices will undergo a quick administrative review by the Health Department of the province where the Registration Holder is located. Approval can be expected in about 5 days. This significantly reduces the review time for Class B devices from 60 days.

Class C and D devices listed in Circular 30/2015 can apply for an Import License if submitted before January 1, 2022 or apply for a Market Authorization (MA) license. Import Licenses will expire December 31, 2022 while MA licenses will remain valid indefinitely. A full list of products found in Circular 30/2015  can be found further below and include ventilators, infant incubators, pacemakers, x-ray machines, MRIs, hemodialysis devices, etc.

Class C and D devices not listed in Circular 30 can continue to be freely imported through December 31, 2022 with only a classification document. This being said, manufacturers of these products are encouraged to obtain a MA License at their earliest convenience.

Device Conformity Assessment

Class A and B devices are subject to a Notification process that is overseen by the provincial offices of the MOH. By handling these administrative reviews, the central MOH has more time to focus on Class C and D applications. Class C and D applications without a Reference Country approval or national standards will need to undergo a Technical Review which could take up to 90 days. Products with a Reference Country approval or the same national standards will avoid the Technical Review and should be approved in about 10 working days.

Applications will continue to require the same documentation as Import Licenses and MA Licenses for Class A until January 1, 2023. Beginning in 2023, Common Submission Dossier Template (CSDT) will be required for all applications.

The application current application requirements consist of administrative documents only (no technical file). Documentation for all Class devices may be submitted in VietNamese or English until January 1, 2023. Some documents like the IFU and Technical Summary will need to be in VietNamese while others like the Letter of Authorization will need to be Legalized.

MA Licenses do not expire under the new Decree.

VietNam has special labeling requirements for registered medical devices including the registration number and License Holder contract information.  Complaint labeling may be affixed after Customs clearance.

Exemptions to the registration process are made for products used for RUO, testing, training, repair, exhibition, or donated devices.  Such devices are subject to a simplified Import License procedure.