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, 20202 stand alone reagents and test kits will be registered as medical device.
New rules governing the registration of medical devices were published in 2016 with Decree No. 36 as amended with Decree No. 169 in 2018 and Decree No. 03 in 2020. Implementation for the new rules began on January 1, 2020, with a 2-year transition period. (See important information on transitioning below.) Once Decree No. 36 is fully in effect, all IVDs will be classified as Medical Devices, requiring an import/product license.
Decree No. 36/2016/ND-CP–effective 1/1/2020 and will be in full force 1/1/2022 (AMDD harmonization)
Decree No. 169/2018/ND-CP – amends Decree 36 adds fast track approval; and CSDT requirement
Decree No. 03/2020 – amends Decree 36 details implementation process of new Rules
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.
VIETNAM IVD REGISTRATION PROCESS
The first step toward regulatory compliance in VietNam for all IVD devices is a classification assessment performed by a certified Classification Agent. The process takes around 3 days and fees vary by device risk class (about US$ 25 for Class A, US$ 50 for Class B, and US$ 75 for Class C or D). The regulatory pathway will vary depending on classification and devices category, until the new rules are fully transitioned on January 1, 2022.
Class A devices are subject to a Notification process. The application is comprised of administrative documents only (no technical file). Documentation may be submitted in VietNamese or English. Certain documents such as the Letter of Authorization, Warrantee Eligibility letter and Certificate of Free Sales (Registration for class A, add CFS in submitted dossier from 2019) must be legalized.
Class B, C and D devices must obtain a Registration Certificate (Market Authorization (MA) License). Technical data demonstrating device conformity assessment must be submitted in ASEAN MDD Common Dossier Submission Template (CDST) format. Quality systems conformity assessment is demonstrated with ISO 13485:2016. Evidence of provisions for after-sales service and warrantee are required. Once issued, an MA License is valid for 5 years.
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.
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.
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
Electrolyte analyzer, blood gas
Blood coagulation machine
Blood sedimentation meter
Elisa test system
Blood type analyzer
Platelet aggregation and function analyzer
Computer identification of bacteria and viruses
Reagents, diagnostic chemicals, cleaning solutions used for medical devices (when used with IVD equipment)
Further, under the old Rules (Decree no. 44), stand alone IVD reagents and test kits are regulated as drugs and require Market Authorization license prior to being imported and sold in VietNam. All MA Licenses will remain valid until their expiry date. MA Licenses that expire after January 1, 2019, but before December 31, 2021 will continue to be valid until the end of December 31, 2021.
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.