Medical Device product registration in Vietnam is overseen by the Department of Medical Equipment and Construction (DMEC), under the Ministry of Health (MOH). Registration requirements for medical devices in Vietnam are currently in a state of transition.
New rules governing the registration of medical devices were published in 2016 with 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, 2020 with a 2-year transition period. (See important information on transitioning below.)
Circular No. 30/2015/TT-BYT – effect 10/12/2015 and will transition out by 12/31/2021
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/ND-CP – amends Decree 36 details implementation process of new Rules
Medical Device Status
In Vietnam, Medical devices are any equipment, tools, materials and chemicals, necessary
software, used alone or in combination that aim to prevent, examine, diagnose and/or mitigate illness or check, replace, modify or offer surgical support during examinations and treatment.
Vietnam closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices, ranging from low to high risk. Uniquely, medical device risk classification in Vietnam must be determined by a locally certified organization or person.
Import License Fee
Standard Review Time
VND 1 million US$43
VND 2 million US$86
VND 3 million
VND 2 million US$86
VND 5 million
VND 2 million US$86
VND 5 milion
VND 2 million US$86
* Pursuant to Circular 64/2020/TT-BTC, the above government fees have been decreased by 30% through the end of 2020.
The first step toward regulatory compliance in Vietnam for all medical devices is a classification assessment performed by a certified Classification Agent. The process takes around 3 days and fees vary by device risk class (about US$ 25 for Class A, US$ 50 for Class B, and US$ 75 for Class C or D). The following regulatory pathway will vary depending on classification and devices category, until the new rules are fully transitioned on January 1, 2022.
Exemptions from the registration process are made for products used for RUO, testing, training, repair, exhibition, or donated devices. Such devices are subject to a simplified, one time Import Permit procedure.
Device Conformity Assessment
Class A devices are subject to a Notification process. The application consists 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. Additionally, quality systems must be demonstrated. Evidence of provisions for after-sales service and warranty are required.
Vietnam has special labeling requirements for registered medical devices including the registration number and License Holder contract information. Compliant labeling may be affixed after Customs clearance.
Quality Systems Conformity Assessment
A Quality Systems Conformity Assessment is required for Class B, C and D devices and can be demonstrated with an ISO 13485:2016.
The new medical device regulations improve the efficiency of the regulatory system, but the transition period can be difficult to navigate.
Exceptions to Home Country Approval Requirement
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
Validity and Renewal
Once issued, an MA License is valid for 5 years.
License Holder Requirements
Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Vietnam to submit registration applications and act as Authorized Representative (AR).
Transition to New Regulations
(Decree 36) from the Old (Circular 30)
Under the old Rules (Circular 30), all foreign manufactured medical devices required an Import License prior to being imported and sold in Vietnam. Import license issued from January 1, 2018 for Class B, C and D medical devices and 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 are listed as 25 working days, but can take up to 60 working days, depending on the number of queries.
From 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 30) 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 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, 2022, these devices will require a Market Authorization License (under the new Rules).
A complete list of devices requiring registration can be found here and all product classifications must be certified by a third party and submitted with the application.
List of Medical Devices that Currently Require an Import License
X-ray treatment equipment
Endoscopic surgery system
Radiotherapy equipment (Cobalt machine for cancer treatment, Linear accelerator for cancer treatment, Gamma scalpel of all kinds, Radiotherapy equipment of various kinds)
Benefits of Independent License Holding through Asia Actual
Sell directly to multiple regional distributors, avoiding mark-up by a national importer
Increase transfer pricing
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
Assure expert handling of post market vigilance and license maintenance
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.