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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.
- 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.
|Class A||Class B||Class C||Class D|
|VND 1 million|
|VND 3 million|
|VND 5 million|
|VND 5 million|
|3-5 days||60 days||60 days||60 days|
Vietnam Regulatory Support
US: +1 512 898-9222
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Expedited Registration Process (30 Days)
The DMEC has also implemented a quick procedure that allows manufacturers of B, C and D medical devices to cut the time for obtaining an Import License in half, to 30 days. Qualifying products include those that have been approved by 2 Reference Countries or has been marketed in VietNam prior to December 31, 2018 for 3 years without any safety issues.
Australia – Canada – European Union – Japan – United States
Transition to New Regulations
(Decree 36) from the Old (Circular 30)
Under the old Rules (Circular no. 30), foreign manufactured IVD equipment with reagents, etc. required an Import License prior to being imported and sold in VietNam. Import licenses issued from January 1, 2018 for Class B, C and D IVD equipment will remain valid until December 31, 2021 (with the proper maintenance of supporting documentation). Import License applications involve mostly administrative documents, with a technical summary, and clinical data for devices related to the heart and central nervous system. Government fees are VND 2M (around US$90) and processing time is listed as 25 working days, but can take up to 60 working days, depending on the number of queries.
As of January 1, 2020 all Class A (without a valid Import License) are required to have a Market Authorization License (under the new rules) to clear Customs and be sold in VietNam.
Specific Class B, C, and D products (listed in Circular 3/2020) are required to have a valid Import License in place in order to clear Customs and be sold in VietNam between January 1, 2020 and January 1, 2022. After which these devices will require a Market Authorization License.
Class B, C, and D products not found on the Circular 3/2020 listing may now clear Customs and be sold in VietNam without an Import License until December 31, 2021, after their classification has been confirmed by a local, qualified classification agent. From January 1, 2020, these devices will require a Market Authorization License (under the new rules).
A complete list of devices requiring registration can be found here. All product classifications must be certified by a third party and submitted with the application.
List of IVD Devices that Currently Require an Import License
|IVDs and Reagents|
|2||Electrolyte analyzer, blood gas|
|4||Blood coagulation machine|
|5||Blood sedimentation meter|
|6||Elisa test system|
|7||Blood type analyzer|
|9||Platelet aggregation and function analyzer|
|10||Computer identification of bacteria and viruses|
|12||Reagents, diagnostic chemicals, cleaning solutions used for medical devices (when used with IVD equipment)|
Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the VietNamese market. Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in VietNam.