MEDICAL DEVICE REGISTRATION CONSULTING SERVICE VIET NAM
Medical Device Registration Consulting Service Viet Nam
Businesses wishing to circulate Medical Devices on the market but are unsure of how their Medical Devices are classified? How to build a dossier to submit to the competent authority correctly and meet legal regulations. Understanding the concerns and worries of customers, Medgate provides a variety of professional and efficient Medical Device registration dossier services for businesses with fast registration time and optimal costs.
You can find professional medical devices registration consulting services for Vietnamese market in Megate JSC.
Medical Device registration is a mandatory administrative procedure stipulated by law for businesses wishing to introduce Medical Devices to the market. All types of Medical Devices intended to be circulated in the Vietnamese market must be granted a product announcement registration certificate by the state authority.
Why Medical Device Registration Dossiers are required and Considerations
Medical devices intended for circulation in the market must be granted licenses by the competent authority, including circulation permits for Medical Devices (including dossier for standard declaration for Class A, B Medical Devices; registration for circulation for Class C, D Medical Devices); Certificate of Manufacturing Eligibility for Medical Device, Certificate of trading Eligibility for Class BCD Medical Devices, and advertising permits for Medical Devices.
The procedure for registering Medical Devices is submitted and evaluated online by the competent authority through the website: https://dmec.moh.gov.vn/.
The circulation number of Medical Devices is valid indefinitely, except in some cases where Medical Devices are urgently issued for the purpose of epidemic prevention or disaster recovery.
* Note: Cases exempt from registering the circulation of Medical Devices (According to Article 24 of Decree 98/2021/ND-CP on the management of medical equipment)
- Medical devices intended solely for research, experimentation, testing, inspection, evaluation, quality assessment, training on instruction for use, repair of medical devices.
- Imported medical devices into Vietnam for aid purposes or for examination and treatment of humanitarian purposes, or for serving activities such as fairs, exhibitions, displays, product introductions, or as gifts for healthcare facilities or individual patient care, or for specific diagnostic needs of healthcare facilities.
- Medical devices without a circulation number imported to meet urgent needs for epidemic prevention, disaster relief, where there are no other equivalent Medical Devices available on the market.
- Medical Devices manufactured in Vietnam solely for export or participation in exhibitions, fairs, or exhibitions abroad.
Medgate’s Services
Medgate offers a variety of medical device services to help customers optimize costs and avoid wasting time searching for reputable and professional service providers, such as:
- Medical Device Classification Consultation
- Declaration of standards applicable to Class A, B Medical Devices
- Registration for circulation of Class C, D Medical Devices
- Declaration of trading eligibility for Class BCD Medical Devices
- Declaration of manufacturing eligibility for Medical Devices
- Local Authorized representative service
- Market research reports on Medical Devices in Vietnam
Contact Us immediately: +84 98.546.1894
Documents need to be sent to the registration company
Declaration of Standards for Class A, B Medical Devices
- ISO 13485 certification
- Letter of Authorization (LOA) from the owner of the Medical Device to the organization responsible for declaring standards
- Certificate of warranty eligibility issued by the Medical Device owner
- Technical brief description of the Medical Device in Vietnamese, accompanied by technical documents describing the functions and specifications of the Medical Device
- Instructions for use of the medical device
- Label template for the Medical Device to be used when circulated in the market
- Valid certification of free sale at the time of submission for imported medical devices
- Certificate of conformity or product standard issued by the owner of the Medical Device
Registration for Circulation of Class C, D Medical Devices
- ISO 13845 certification
- Letter of Authorization (LOA)
- Certificate of warranty eligibility
- Circulation certificate and Import license or Circulation number or circulation registration certificate
- Common Submission dossier Template on medical devices as per ASEAN regulations (specific details vary for each product type)
- Certificate of conformity
- Other relevant documents depending on the product type
- Technical brief description of the Medical Device of the Medical Device in Vietnamese, accompanied by technical documents describing the functions and specifications of the Medical Device
- Instructions for use
- Label template
Declaration of Manufacturing Eligibility for Medical Devices
- ISO 13485 certification
- Documents proving compliance with regulations for Medical Device manufacturing facilities containing narcotics, precursors
Declaration of Trading Eligibility for Class BCD Medical Devices
- List of medical devices that entity trade
- Personnel declaration form
- Documents proving warehouse storage, transportation means for Medical Devices
Contact Us immediately: +84 98.546.1894
What to Consider When Preparing Documentation?
- Check the validity period of documents to ensure timely supplementation
- Legalization of documents by consular authorities: Certificate of Free sale (CFS) is valid at the time of submission, Authorization letter (LOA) from the owner of the Medical Device to the organization responsible for declaring standards, Warranty certification (Not applicable for single-use devices or in case manufacturer does not have warranty policy for the device).
- ISO 13485: scanned copy
- Authorization letter indicating all types/product codes
- Provide Vietnamese names for Medical Devices in the registration dossier.
Workflow at Medgate and Timeframes for Results
Workflow at Medgate
- Customer Information Reception: Specialist receives customer information, exchanges preliminary information (list of documents required for requested services such as classification, standard declaration, registration for circulation, trading eligibility declaration for medical devices as outlined in section 5).
- Service Consultation: Specialist discusses with the customer regarding the implementation process, cost quotation, negotiation, and contract signing.
- Service Implementation: Specialist checks whether the documentation is complete and compliant with the regulations of the Ministry of Health. If any issues arise, they inform the customer promptly for timely supplementation or adjustments to avoid delays. Subsequently, on behalf of the customer, the specialist prepares the documentation and submits it to competent authority, working with them.
- Return Results to the Customer
Return Results to the Customer
- Classification and standard declaration applicable to Class A, B Medical Devices: 5-10 days
- Classification and registration for circulation for Class C, D Medical Devices: 1 year
- Declaration of manufacturing eligibility for Medical Devices: 5-10 days
- Declaration of trading eligibility for Class BCD Medical D: 5-10 days
- Advertising Certificate for Medical Devices: 1-2 days
Why Choose Medgate VietNam?
- Professional, Experienced Personnel Team: Our team consists of highly skilled professionals with years of experience in medical device registration.
- Time Efficiency and Early Registration number return: Our experienced specialists in the preparation and processing of documentation help minimize errors during the product declaration process. This helps avoid multiple revisions to documents.
- Reasonable costs: Medgate has very competitive registration costs in the market, one of the units with the lowest registration service costs.
- In addition to providing a variety of medical device registration services, Medgate is a reputable and trustworthy unit that is a Local Authorized representative (in cases where foreign traders do not have a representative office in Viet Nam)
- Market Promotion Support: We also support market promotion activities such as exhibitions, events to introduce products and enhance brand promotion
If you are interested in our services, please contact our hotline at +84 98.546.1894 or email us at medgatevn@gmail.com for consultation on dossier services, procedural processes, registration fees, and medical device advertising.
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