Medical Device product registration 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 back 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 is stated 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

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 Medical Device Registration Process

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). Then 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 from the registration process are made for product used for RUO, testing, training, repair, exhibition, or donated devices.  Such devices subject to a simplified, one time Import Permit procedure.

Another important and unique issue to Vietnamese regulations is product grouping. 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.

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.

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, 2020, 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