Vietnam Medical Device Registration

Understanding Medical Device Registration in Vietnam

Updated On: 19/01/2024

Regulatory Authority: Department of Medical Equipment and Construction (DMEC)

The Ministry of Health (MOH) oversees executing legislative papers, strategies, guidelines, and blueprints concerning medical devices. Under the purview of the MOH, the Department of Medical Equipment and Construction (DMEC) is tasked with supervising the issuance of import licenses, registration numbers for medical devices categorized as Class B, C, and D, issuing Certificate of Free Sales, and validating advertising content.

Link for Regulatory Authority: https://dmec.moh.gov.vn/trangchu

Local Regulation: Decree 98/2021/ND-CP

Classification: Class A, B, C and D

Listing or Registration Requirements:

• Upon receipt of the classification result, class A medical device registration applications must be uploaded to the local department of health via an online portal. Upon approval a Notification of Applicable Standard will be issued. This has a lifetime validity.
• All class B, C and D medical device registration applications must be submitted to the DMEC via the online portal. Upon approval a Circulation Registration Certificate (Product license) will be issued. This has a validity of 5 years.

 Documents Required:

• The application forms
• Class A application declaration
• Classification table of medical equipment
• Certificate of quality control standards
• Letter of authorization by the owner of the medical equipment
• Certificate of eligibility to provide warranty
• Certificate of conformity
• Written instructions for the device
• Device label
• Certificate of Free Sales
• Catalog describing functions, specifications, and other technical information for device
• Brief description of medical equipment (in Vietnamese)
• For class C or D devices, summary of clinical testing data and certificate of inspection

 Registration Timeline:

• Class A and B – Immediate
• Class C and D- 10 to 90 days

 Registration Fee:

• Class A – US $43
• Class B – US $130
• Class C and D – US $216

License Validity: Decree 07/2023/ND-CP Extends the validity of existing Import Licenses to December 31, 2024, providing a transitional period.

Special Labelling Requirements:

• 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.
• Any statements not in English or Vietnamese must be translated into the latter.

 Import permits:

Cases requiring an import license:

1. Medical equipment without a free-sale registration number imported only to serve scientific research, inspection, testing, testing, quality assessment, or training in the use and repair of equipment. medical equipment.
2. Imported medical equipment without a free-sale registration number to meet urgent needs for disease prevention and control, and to overcome consequences of natural disasters.
3. Medical equipment without a free-sale registration number imported for aid or humanitarian aid purposes; gifts and presents for medical establishments; serving fairs, exhibitions, display, or product introduction. Medical facilities have not had a circulation of import operations to serve medical, humanitarian medical.
4. Medical equipment without a free-sale registration number imported for use for personal treatment, including specific medical equipment or according to the special diagnostic needs of a medical establishment.
5. Used medical equipment: – Imported for research and training purposes (do not practice on humans and do not use these medical devices for diagnostic and therapeutic purposes); – Temporarily imported for re-export for display, introduction, participation in trade fairs and exhibitions.

Dossier, order and procedures for import, temporary import and re-export of medical equipment comply with the law on foreign trade management.

Additional Comments: Devices listed under Circular 30 are subject to apply for import license. While devices not listed in Circular 30, are subject to apply for product license. However, the circumstances that Circular 30 will soon be fully replaced by Decree 36 in January 2022, all import licenses under Circular 30 are not subject to renewal and will be valid only until 31 December 2022. Starting on January 1st, 2022, both Decree 36 and 169 will be fully implemented including ASEAN Common Submission Dossier Template (CSDT).

Quick issuance is the registration pathway for devices that have been circulated in at least 1 of the following countries: Japan, Canada, Australia, USA, or EU member countries.

 Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

https://asiaactual.com/vietnam/medical-device-registration/