MEDICAL DEVICE REGISTRATION IN VIETNAM GOVERNMENT AUTHORITY
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 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. However, since the implementation of 98/2021, very few Class C and D Market Authorization (MA) Licenses have been issued and previously issued Import Licenses have had their validity auto-extended to December 31, 2024 via Decree 07/2023. You can read more about the latest decree here.
IMPORTANT MEDICAL DEVICE REGULATIONS IN VIETNAM
Decree No. 98/2021/ND-CP – effective Jan 1, 2022
Decree No. 111/2021 – Amends Decree No. 43/2017 and Updates Labeling requirements
Circular 05/2022 – Provides a list of products that require registration prior to importation.
Decree 07/2023 (EN/VN)- Extends the validity of Import Licenses and delays implementation of CSDT application requirements, as well as additional clarifications. You can read more about this decree here.
PREVIOUS GOVERNING REGULATIONS
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)
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.
Under new rules, Software is considered a medical device.
Vietnam closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices, ranging from low to high risk. Previously, medical device risk classification in Vietnam had to be determined by a locally certified organization or person but under the new regulations, the Registration Holder can classify the product as part of the application.
DMEC FEES / MA LICENSES REVIEW TIME
Class A: VND 1 million (~US$43) Immediate
Class B: VND 3 million (~US$130) Immediate
Class C: VND 5 million (~US$216) Target: 10 to 90 days, Actual: 1 or more Years
Class D: VND 5 million (~US$216) Target: 10 to 90 days, Actual: 1 or more Years
*The MOH is currently providing a 30% discount for all Class C and D processing fees until the end of 2024.
REGULATORY PATHWAY IN VIETNAM
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.
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. The registration number will be issued immediately and significantly reduces the review time for Class B devices from 60 days.
REGULATORY REQUIREMENTS FOR NEW MEDICAL DEVICES
The current application requirements consist of administrative documents only (no technical file). Documentation for all Class devices may be submitted in Vietnamese or English until at least January 1, 2025 (updated in March 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. Eventually, manufacturers will need to submit their application in the Common Submission Dossier Template (CSDT) format.
MA Licenses do not expire under the new Decree.
CLASS A AND B MEDICAL DEVICES
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 A and B MA License applications that leverage Reference Country approval are typically approved within 1 week.
CLASS C AND D MEDICAL DEVICES
Class C and D devices listed in Circular 30/2015 required an Import License or Market Authorization (MA) License prior to importing and marketing in Vietnam. Existing Import Licenses will now expire on December 31, 2024 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, 2024 with only a classification document. This being said, manufacturers of these products are encouraged to obtain a MA License at their earliest convenience.
Products with a Reference Country approval or the same national standards will avoid the Technical Review and we planned to be approved in about 20 working days. Howvever, the MOH has experienced significant delays and have only approved a very limited amount of Class C/D MA Licenses. 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.
Note: As of March 2023, very few Class C or D MA Licenses have been issued. Please see our article on Decree 07/2023 outlining the extension of Import License validity and delay of CSDT documentation.
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
ADDITIONAL REGULATORY NOTES
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 from the registration process are made for products used for RUO, testing, training, repair, exhibition, or donated devices
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.
Please see a brief table outlining the recent updates:
Price Declaration Updates Decree 98/2021 (01 April 2022- 02 March 2023) Decree 07/2023 (03 March 2023 – Present)
Responsible Party License holder Trading company
Medical devices All medical devices Only those on the MOH’s list
Hospital tenders Required to sell or buy under Price Declaration Only those on the MOH’s list
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.
EXPEDITED REVIEW FOR REFERENCE COUNTRY APPROVAL
The MOH has also updated the expedited review process for medical devices with at least 1 Reference Country approval, which includes the USA, Canada, Europe, Japan, or Australia. As part of 98/2021, the MOH extended acceptable Reference Country approval to China’s NMPA and Korea’s MFDS. Products with an approval from at least one of these markets will still need to submit the required documentation (technical summary, label, IFU, brochure until Dec. 31, 2024, then CSDT) but will not undergo a technical dossier evaluation which intends to shorten the wait time from 60 working days to 10. Expedited review has not officially begun for Class C and D applications.