PROCEDURES FOR REGISTRATION AND PUBLICATION OF MEDICAL DEVICE CIRCULATION

Kinh Doanh Phòng
Dec 22, 2025
10 min read

Medical devices, in order to be circulated on the market, are required to obtain a circulation number. For Class C and Class D medical devices, which are classified as having medium-high to high risk levels, the circulation number of the medical device shall be the Medical Device Circulation Registration Certificate number.

1. Conditions for Issuance of the Registration Certificate for Declaration of Circulation of Class C and Class D Medical Devices

Being manufactured at a manufacturing facility that has declared its eligibility to manufacture medical devices, in the case of domestically manufactured medical devices;
Being manufactured at a manufacturing facility that has been granted an ISO 13485 Quality Management System Certificate and being lawfully circulated in any country worldwide, in the case of imported medical devices;
Being compliant with national technical regulations or standards declared by the manufacturer as applicable.

2. Conditions Applicable to Organizations Registering the Declaration of Circulation of Class C and Class D Medical Devices

Vietnamese enterprises, cooperatives, or household businesses that are the owners of medical devices; or that are authorized by the owners of medical devices; or permanent representative offices in Vietnam of foreign traders who are the owners of medical devices or are authorized by the owners of medical devices.

The organization whose name is stated in the declaration of applicable standards or in the registration for circulation of medical devices must have a warranty facility in Vietnam or must enter into a contract with an organization having adequate capacity to provide warranty services for medical devices, except for single-use medical devices as stipulated by the medical device owner or in cases where documents proving that no warranty regime applies are available.

► In case the organization whose name is stated in the declaration of applicable standards for medical devices is a permanent representative office in Vietnam of a foreign trader who is the owner of the medical devices or is authorized by the medical device owner, the medical device owner must have a warranty facility in Vietnam or must enter into a contract with an organization having adequate capacity to provide warranty services for medical devices, except for single-use medical devices as stipulated by the medical device owner or in cases where documents proving that no warranty regime applies are available.

The warranty facility must be certified by the medical device owner as having adequate capacity to provide warranty services for the products.

► Cases in which medical devices are exempt from registration for declaration of circulation

Medical devices used solely for the purposes of research, testing, inspection, examination, appraisal, quality evaluation, training and instruction on use, or repair of medical devices.

Medical devices imported into Vietnam for the purposes of aid or humanitarian medical examination and treatment, or for use in trade fairs, exhibitions, displays, or product introduction activities, or for use as gifts or donations to medical establishments, or for personal medical treatment, specific personal use, or in response to special diagnostic needs of medical establishments.

Medical devices without a circulation number imported to meet urgent needs for epidemic prevention and control, or for remediation of consequences of natural disasters or catastrophes, where no alternative medical devices are available on the market.

Medical devices manufactured in Vietnam solely for export purposes or for participation in overseas exhibitions, trade fairs, or displays.

► Forms of registration for declaration of circulation of Class C and Class D medical devices

1. Initial Issuance of Circulation Numbers for Medical Devices

The form of initial issuance of circulation numbers for Class C and Class D medical devices shall apply to medical devices submitted for circulation number issuance for the first time, as well as to medical devices that have been granted a circulation number but undergo one of the following changes: changes in the medical device owner; type of medical device; category, intended purpose, intended use, or indications for use; quality standards; addition of manufacturing facilities or product codes; manufacturing materials affecting the function of in vitro diagnostic medical devices and single-use medical devices; concentration, content, or composition of materials that are pharmaceutical substances combined in a medical device with a supportive role for therapeutic purposes.

a) For medical devices that are subject to corresponding national technical regulations

► The dossier for application for initial issuance of a circulation number shall include the following documents:

An application for initial issuance of a circulation number.
A valid ISO 13485 Quality Management System Certificate at the time of dossier submission.
A valid authorization letter from the medical device owner authorizing the establishment to carry out the circulation registration at the time of dossier submission.
A certificate of eligibility for warranty issued by the medical device owner, except for single-use medical devices or cases where documents proving that no warranty regime applies are available.
A valid circulation certificate at the time of dossier submission for imported medical devices.
A Certificate of Conformity.

► The Common Submission Dossier Template (CSDT) for medical devices in accordance with ASEAN regulations, applicable to dossiers submitted from 01 January 2023.

For dossiers submitted before 31 December 2022: A technical summary description of the medical device in Vietnamese, enclosed with technical documents describing the functions and technical specifications of the medical device issued by the medical device owner. Specifically, for in vitro diagnostic reagents, calibrators, and control materials: technical documents in Vietnamese enclosed with documents on raw materials, product safety, manufacturing processes and quality control, and clinical and pre-clinical study reports, including stability study reports.

b) For medical devices that are measuring instruments subject to model approval in accordance with the law on measurement

► The dossier shall include:

An application for initial issuance of a circulation number.
A valid ISO 13485 Quality Management System Certificate at the time of dossier submission.
A valid authorization letter from the medical device owner authorizing the establishment to carry out the circulation registration at the time of dossier submission.
A certificate of eligibility for warranty issued by the medical device owner, except for single-use medical devices as stipulated by the medical device owner or cases where documents proving that no warranty regime applies are available.
A valid circulation certificate at the time of dossier submission for imported medical devices.
A decision on model approval.

► The Common Submission Dossier Template (CSDT) for medical devices in accordance with ASEAN regulations, applicable to dossiers submitted from 01 January 2023.

Instructions for use of the medical device.
The sample label to be used when the medical device is circulated in Vietnam.

c) For other medical devices

► The dossier shall include:

An application for initial issuance of a circulation number.
A valid ISO 13485 Quality Management System Certificate at the time of dossier submission.
A valid authorization letter from the medical device owner authorizing the establishment to carry out the circulation registration at the time of dossier submission, except for cases specified in Point a, Clause 1, Article 25 of this Decree.
A certificate of eligibility for warranty issued by the medical device owner, except for single-use medical devices as stipulated by the medical device owner or cases where documents proving that no warranty regime applies are available.
A valid circulation certificate at the time of dossier submission for imported medical devices.
The appraisal result of the CSDT dossier issued by an entity designated by the Minister of Health, enclosed with the CSDT dossier.

► For in vitro diagnostic medical devices that are reagents, calibrators, or control materials, an additional quality certificate issued by a competent authority of Vietnam is required.

For chemicals and preparations used solely for the purpose of disinfecting medical devices, additional documents are required, including:

A test report on the composition and concentration of disinfectant active substances issued by an organization that has declared eligibility to conduct testing in accordance with the law on management of chemicals and insecticidal and disinfectant preparations used in household and medical fields;
A test report on biological efficacy evaluation of the product and its side effects on test participants issued by an organization that has declared eligibility to conduct testing in accordance with the law on management of chemicals and insecticidal and disinfectant preparations used in household and medical fields.

2. Expedited Issuance of a New Circulation Number

a) Applicable cases:

► Case 1: The medical device has been granted a Certificate of Free Sale (CFS) or a Market Authorization (hereinafter collectively referred to as the “Circulation Certificate”) by one of the following authorities or countries: the U.S. Food and Drug Administration (FDA) – United States; the Therapeutic Goods Administration (TGA) – Australia; Health Canada – Canada; the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceuticals and Medical Devices Agency (PMDA) – Japan; member states of the European Union (EU), the United Kingdom, Switzerland; the National Medical Products Administration (NMPA) – China; the Ministry of Food and Drug Safety (MFDS) – Republic of Korea; or organizations included in the list of authorities issuing Circulation Certificates recognized by the competent authority of Viet Nam (hereinafter referred to as the “Reference Countries”).

► Case 2: The medical device has been granted an Import License, a Circulation Number, or a Certificate of Registration for Circulation in Viet Nam in the form of commercial registration.

b) Dossier components:

A written request for issuance of a new Circulation Number.
Documents as prescribed at Points b, c, and d, Clause 1 of this Article.
The Circulation Certificate issued by one of the Reference Countries, applicable to Case 1.
The Circulation Certificate for imported medical devices and the Import License or Circulation Number or Certificate of Registration for Circulation, applicable to Case 2.
A Quality Assessment Certificate issued by the competent authority of Viet Nam for in vitro diagnostic medical devices, except for the following cases:
- Devices classified under Lists A and B of Appendix 2 of the European In Vitro Diagnostic Medical Devices Regulation and having been granted a Certificate of Free Sale by one of the EU member states, the United Kingdom, or Switzerland;
- Devices classified under Lists A and B of Appendix 2 of the European In Vitro Diagnostic Medical Devices Regulation and having been granted a Market Authorization by one of the Reference Countries;
- Devices not classified under Lists A and B of Appendix 2 of the European In Vitro Diagnostic Medical Devices Regulation but having been granted a Market Authorization by one of the Reference Countries;
- Devices included in the list promulgated by the Minister of Health.

3. Emergency Issuance of a New Circulation Number

a) Applicable subjects:

Medical devices serving epidemic prevention and control, remediation of consequences of natural disasters and catastrophes in urgent cases (in accordance with the List promulgated by the Minister of Health) and falling into one of the following cases:

Having been permitted for circulation or emergency use by one of the Reference Countries;
Being included in the list of products authorized for emergency use published by the World Health Organization (WHO);
Being included in the list of common products published by the European Health Security Committee (Health Security Committee – EUHSC);
Having been granted a Circulation Number or an Import License under the commercial form in Viet Nam, except for cases that were revoked prior to the effective date of this Decree;
Being domestically manufactured under a technology transfer arrangement for medical devices falling into one of the cases specified at Points a, b, c, or d of this Clause;
Being domestically manufactured under a processing (contract manufacturing) arrangement for medical devices falling into one of the cases specified at Points a, b, c, or d of this Clause.

b) Dossier components:

A written request for issuance of a new Circulation Number.
A valid ISO 13485 Quality Management System Certificate at the time of dossier submission.
A letter of authorization from the medical device owner authorizing the establishment to carry out the circulation registration, valid at the time of dossier submission, except for the case prescribed at Point a, Clause 1, Article 25 of this Decree.
A certificate of eligibility for warranty issued by the medical device owner, except for single-use medical devices as stipulated by the medical device owner or where there is documentation proving that no warranty regime applies.
A Circulation Certificate or an emergency use authorization for imported medical devices.
A technology transfer contract (applicable to cases where a Circulation Number or an Import License under the commercial form has been granted in Viet Nam).
A processing (contract manufacturing) agreement (applicable to cases of domestic manufacturing under a processing arrangement).
A certificate of inspection or product quality assessment issued by one of the entities included in the list published on the Ministry of Health’s electronic information portal, applicable to domestically manufactured medical devices; or medical devices that have been permitted for circulation or emergency use by competent authorities of EU member states, the United Kingdom, or Switzerland but are not included in the list of common products published by the European Health Security Committee (EUHSC).

► Procedure for registration and publication of circulation of Class C and D medical devices

Step 1: The organization applying for a Circulation Number shall submit the dossier to the Ministry of Health and pay the prescribed fee via the Ministry of Health’s Administrative Procedures Information System (https://dichvucong.moh.gov.vn) or the Electronic Portal on Medical Device Management (https://dmec.moh.gov.vn/).

Step 2: Where no request for amendment or supplementation of the circulation registration dossier is made, the Minister of Health shall be responsible for organizing the appraisal and issuing the Circulation Number from the date of receipt of a complete and valid dossier within the following time limits:

30 days for medical devices that have corresponding national technical regulations and measuring instruments subject to type approval, or 45 days for other medical devices;
10 working days for expedited issuance and emergency issuance of a new Circulation Number for medical devices.

Step 3: Upon receipt of a request for supplementation or amendment of the dossier, the applying establishment shall supplement or amend the dossier strictly in accordance with the notified contents and submit it to the Ministry of Health.

Where the applying establishment has supplemented or amended the dossier but not in accordance with the requirements, the Ministry of Health shall notify the establishment to continue completing the dossier in accordance with regulations.

After 90 days from the date the Ministry of Health issues the request, if the establishment fails to supplement or amend the dossier, or if after 05 rounds of amendment and supplementation from the date of the first request by the Ministry of Health the dossier still fails to meet the requirements, the procedure must be recommenced from the beginning.

Step 4: Within 01 working day from the date of issuance of the Circulation Number, the Ministry of Health shall be responsible for publicly disclosing the medical device information on the Electronic Portal on Medical Device Management.