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Vietnam Extends Validity of Medical Device Import Licenses
Published on: March 8th, 2023
On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (“Decree 07/2023”), which among other items, automatically extended the validity of existing Import Licenses to December 31, 2024. This comes after significant delays implementing the new regulations (Decree 98/2021) released at the end of 2021. These delays have been the subject of several other recent updates, which you can read about here.
Additionally, the Decree states that class C and D medical devices not listed in Circular 05/2022 can be imported freely. A full list of product types listed in Circular 05/2022 is found below. All class A & B medical devices must obtain a Market Authorization (MA) License prior to importation. More information on the registration process can be found here and a link to the MoH’s announcement can be found on their website here.
Given the continuously changing regulatory environment in Vietnam, please contact us with any questions or to learn more about your product’s specific regulatory requirements. For more information on the Vietnamese Import License best practices, visit our website here.
Background on Medical Device Regulatory Requirements
Originally, when Decree 98/2021 was released, Vietnamese Import Licenses issued from January 1st, 2013 to December 31st, 2021 were to expire at the end of 2022. However, the Vietnamese MOH was unable to successfully implement the new requirements for Class C & D MA Licenses, leading to a lower volume of medical device imports in the country and a shortage at some hospitals.
Import licenses had previously been extended to the end of 2023 by the MoH in September of 2022. However, since January 1, 2023, manufacturers have had issues importing products under their Import Licenses given they technically expired at the end of 2022. With the release of the new Decree 07/2023 the MoH has provided needed clarity to help medical devices make it through customs.
Updates to Vietnamese MoH Import License Policies
In addition to the extension of import licenses, there are several other updated protocols and stipulations in Decree 07/2023 from the MoH that concern import licenses for medical devices. They are as follows:
- Applications for Import Licenses submitted before January 1st, 2022, will continue to be processed by the MoH. Import Licenses issued under this clause are valid until December 31st, 2024.
- Class C/D devices that are not listed in Circular 05/2022 can be freely imported until December 31st, 2024.
- The MoH will issue a list of medical devices that must declare their pricing starting July 1st, 2023. The price declaration rule applies only to medical devices (no other products). The regulation is not mandatory for bidding packages opened prior to April 1st, 2022.
- The implementation of the Common Submission Dossier Template (CSDT) will be delayed until at least January 1st, 2024. All device applications, regardless of risk class, will continue using the currently required documents: (Technical Summary (in Vietnamese), IFU (in Vietnamese), Labelling, CER, Brochure) in lieu of CSDT.
- Import Licenses issued to IVD products between January 1, 2018 and December 31, 2021 can continue to be used until December 31, 2024.
Updates to Price Declaration Process
Also updated by Decree 07/2023 was the Price Declaration process. Previously, all devices needed to be list and the License Holder was required to list the price on behalf of the manufacturer. Now, only the actual trading company is required to list the products on the public portal and only a specified list of products need to be listed.
Class C and D Products That Require Registration in Vietnam
The following Class C and D devices require an Import License or MA License to be sold in Vietnam. Class C/D devices not listed below and found in Circular 05/2022 can be freely imported until December 31st, 2024.
The products listed in Circular 05/2022 include:
- X-ray imaging equipment
- Magnetic resonance systems
- Diagnostic ultrasound machine
- Diagnostic endoscopy system
- Cyclotron system
- Radioisotope diagnostic equipment (system PET, PET/CT, SPECT, SPECT/CT, device for measuring iodine concentration I 130 , I 131 )
- Automatic refractometer, cornea
- Electrophysiological machine (electrical machine, electrocardiogram machine, electromechanical machine)
- Osteoporosis meter
- Fundus tomography machine; fundus fluoroscopy machine
- Ultrasound fetal heart rate monitor
- Respiratory function analyzer/meter
- Biochemistry analyzer; electrolyte and blood gas analyzer
- Hematology analyzer; blood group analyzer
- Coagulation meter; erythrocyte sedimentation rate meter
- Elisa test system
- Cell extractor
- Platelet aggregation and function analyzer
- Bacterial and virus identification machine
- Immunoassay machine
- In vitro reagents, calibrators, and control materials
- X-ray treatment equipment
- Laparoscopic surgery system
- Radiation therapy equipment (cobalt machine for cancer treatment, linear accelerator for cancer treatment, gamma scalpel of all kinds, Brachytherapy equipment of all kinds)
- Patient monitor
- Infusion pump; electric injection pump
- Scalpel (high frequency electricity, laser, ultrasound).
- Surgical microscope
- Prostate surgery equipment system
- Artificial heart-lung machine
- Positioning device in surgery
- Cryosurgery equipment
- Newborn incubators; baby warmer
- Anesthesia/anesthesia machine with breathing apparatus
- Defibrillator, pacemaker
- High pressure oxygen chamber
- Extracorporeal lithotripsy/endoscopic lithotripsy system
- System of high-intensity ultrasound equipment for tumor treatment
- Dialysis equipment
- System of specialized ophthalmic surgery (Laser Excimer, Phemtosecond Laser, Phaco, Vitreous cutter, Corneal flap cutter)
- Eyeglasses, contact lenses (nearsightedness, farsightedness, astigmatism) and contact lens preservation solution
- Laser machine for ophthalmology
- Long-term (over 30 days) implantation of devices and materials into the body
- Types of equipment and materials for intervention in the body of cardiology, cranial nerves
Rules from Vietnamese MoH for Devices with Revoked Registration Numbers
Additionally, there are new regulations to better clarify the handling of medical devices in the situation that their registration number has been revoked. According to Article 39a:
- Handling of medical equipment after revoking the circulation number: Medical equipment sold to medical facilities after having their registration number revoked can be used until the device’s expiration date.
- In the case the medical equipment with the free-sale registration number has been withdrawn and not been sold to a medical facility, the owner of the free-sale registration number is responsible for stopping the circulation of said equipment and/or taking measures to recall the medical equipment.
Come Grow With Us
Please contact us if you need more information on medical device registration in Vietnam. Asia Actual has an office in Vietnam located in Ho Chi Minh City staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asian markets through independent license holding, direct fulfillment, and a variety of sales channel support services.