Medical Equipment Circulation Registration Procedures
Medical equipment (referred to as ME) is a category of products with many risks in the process of use and needs to be guided and strictly controlled so as not to affect the health and life of users. Currently, there are many poor-quality ME products on the market, without clear origin, which greatly affects consumers. To prevent the import of such products, the Ministry of Health has issued strict policies requiring businesses trading in ME to register for ME circulation. Based on Decree 36/2016/ND-CP amended and supplemented by some articles of Decree 169/2018/ND-CP on guiding the application for a certificate of registration for ME circulation, Thiên Di guides customers on how to apply for a circulation license as follows:
1. Legal basis
Based on the following decrees on regulations on ME management, to be allowed to circulate ME, businesses must:
- Decree 36/2016/ND-CP
- Decree 169/2018/ND-CP
2. What is the circulation number of ME?
Clause 1, Article 20 of Decree 36/2016/ND-CP on ME management, stipulates that the circulation number of ME is:
- The number of the file receiving the application for announcing the applied standard for ME of type A according to form No. 03 specified in Appendix IV issued together with this Decree;
- The number of the certificate of registration for circulation for ME of type B, C, D according to form No. 09 specified in Appendix IV issued together with this Decree.
Accordingly, we would like to inform you more about the validity of the circulation number:
- The circulation number of ME of type A is valid indefinitely;
- The circulation number of ME of type B, C, D is valid for 05 years from the date of issuance. In case the ME is granted an extension of the circulation number, the previously issued circulation number will be retained.
3. What is a Medical Device Circulation Registration Certificate?
A Medical Device Circulation Registration Certificate is a document issued by a government agency that confirms a Class B, C, or D medical device has been granted a circulation number and can be distributed on the market. For Class B, C, and D medical devices, the correct term is "circulation registration." For Class A medical devices, the term is "declaration of applicable standards."
The Medical Device Circulation Registration Certificate, or the circulation number of the medical device, is the registration certificate number for Class B, C, and D medical devices. A circulation number can be issued for one or a group of medical device types. The holder of the circulation number is the organization that is granted the circulation number for Class B, C, and D medical devices.
4. Why is Medical Device Circulation Registration Necessary?
Article 20 of Decree 36/2016/ND-CP on the management of medical devices stipulates the following regarding the circulation number of medical devices:
1. The circulation number of a medical device is:
a) The number of the application receipt for the declaration of applicable standards for Class A medical devices according to Form No. 03 in Appendix IV issued with this Decree;
b) The number of the Medical Device Circulation Registration Certificate for Class B, C, and D medical devices according to Form No. 09 in Appendix IV issued with this Decree.
2. The circulation number of a medical device can be issued for one or a group of medical device types.
3. The holder of the circulation number is the organization that declares the applicable standards for Class A medical devices or the organization that is granted the circulation number for Class B, C, and D medical devices.
4. Validity of the circulation number:
a) The circulation number of a Class A medical device is valid indefinitely;
b) The circulation number of a Class B, C, or D medical device is valid for 05 years from the date of issue. If the circulation number of a medical device is extended, the original circulation number will be retained.
Accordingly, Clause a, Point 2, Article 54 of Decree 176/2013/ND-CP stipulates the following:
A fine of VND 10,000,000 to 20,000,000 shall be imposed on the following acts:
- Trading in medical devices without a medical device circulation registration number, an import license from a competent government agency, or a certificate of origin.
In addition, the violating establishment will have its medical devices confiscated.
5. When is a medical device registration certificate required?
Classification of medical devices:
Medical devices are classified into two groups and four categories based on the potential risk associated with their technical design and manufacturing:
Group 1: Class A medical devices are low-risk medical devices.
Group 2: Class B, C, and D medical devices, where:
- Class B medical devices are medium-low risk medical devices.
- Class C medical devices are medium-high risk medical devices.
- Class D medical devices are high-risk medical devices.
Not all medical devices require a medical device registration certificate. Only after the classification procedure is completed and the medical device is classified as Class B, C, or D, is the registration procedure required. Class A medical devices only require a standard announcement procedure.
If a distributor distributes or sells products that have already been registered by another entity, they do not need to register the medical device again.
6. General conditions for medical device registration:
The general conditions for medical device registration include:
- The distributor must have a registration number and be licensed to import medical supplies according to regulations.
- All medical devices in circulation must have labels and secondary labels with complete information about the product according to regulations.
- Medical devices must be accompanied by instructions for repair and maintenance, except for single-use medical devices.
- Medical devices and supplies must have specific instructions for use in Vietnamese.
- Specific information about the place of warranty, time, and conditions for warranty, except for single-use medical devices and supplies that do not require warranty according to regulations.
6.1. Conditions for circulation of medical devices:
According to Article 17 of Decree 36/2016/ND-CP amended and supplemented by some articles of Decree 169/2018/ND-CP, medical devices must:
- Have a circulation number or have been granted an import license according to this Decree, except for medical gases.
- Have a label or be accompanied by a secondary label with complete information according to regulations.
- Have technical documentation for the repair and maintenance of medical devices, except for single-use medical devices according to the regulations of the medical device owner;
- Have information on the instructions for use of the medical device in Vietnamese;
- Have information on the warranty facility, conditions, and time, except for single-use medical devices according to the regulations of the medical device owner or have documentation proving that there is no warranty policy.
6.2. Conditions for the certificate of registration for circulation of medical devices:
- Be manufactured at a manufacturing facility that has declared sufficient conditions for manufacturing for domestically manufactured medical devices;
- Be manufactured at a manufacturing facility that has been granted a Certificate of Conformity to Quality Management Standards and is circulated in any country in the world for imported medical devices;
- Conform to national technical standards or standards that the manufacturer declares applicable.
6.3. Conditions for organizations that are registered to circulate medical devices:**
Organizations that are registered to circulate medical devices include:
- Vietnamese enterprises, cooperatives, and business households that are the owners of medical devices;
- Vietnamese enterprises, cooperatives, and business households that have the function of trading medical devices and are authorized by the owner of the medical device to register;
- The representative office in Vietnam of a foreign trader where that trader is the owner of the medical device or is authorized by the owner of the medical device.
The organization registered to circulate medical devices must have a warranty facility in Vietnam or must have a contract with an organization with the capacity to warranty the medical devices that it is registered for, except for single-use medical devices according to the regulations of the medical device owner.
In the case where the organization registered to circulate medical devices is under the regulation of point c, clause 1, Article 21 of Decree 36/2016/ND-CP, the owner of the medical device must have a contract with an organization with the capacity to warranty the medical device that it is registered for, except for single-use medical devices according to the regulations of the medical device owner.
The warranty facility must be certified by the owner of the medical device as having the capacity to warranty the product that the organization registered for is requesting a circulation number.
7. Notes on Medical Device (MD) Circulation Registration
Re-registration of MD circulation is not allowed in the following cases:
- MD with a circulation number but the owner declares to cease production or goes bankrupt/dissolves:
- Can still be circulated for a maximum of 24 months from the time of declaration.
- The owner of the circulation number in Vietnam must commit to:
- Warranty and maintenance.
- Providing spare parts and consumables for the use of MD for 8 years.
- Recalled MD:
- MD for which the circulation registration application is not accepted or registered within 12 months from the date of the decision to withdraw the circulation number, in the following cases:
- 3 batches of MD are recalled during the validity of the circulation number, except for voluntary recalls by the owner of the circulation number.
- MD has expired according to regulations.
8. Procedures for Applying for a Medical Device Circulation Registration Certificate
Compile the application dossier in accordance with the required procedures for registering the circulation of medical devices.
Submit the complete and valid application dossier to the Ministry of Health, the authority responsible for granting medical device circulation licenses.
Within 15 days from the date of receiving the complete application, the Ministry of Health will review the application and issue a circulation registration number for the medical device.
9. What documents and procedures are required to apply for a medical device circulation registration certificate?
To apply for a medical device (MD) circulation registration certificate in Vietnam, customers need to prepare the following documents and procedures:
- Application form for medical device circulation registration
- Copy of the certificate of manufacturing and trading of medical devices
- Declaration of conformity of medical device quality standards or declaration of medical device
- Product testing report at least 03 medical facilities in Vietnam
- Test results of physiological and chemical properties ensuring safety for patients
- Technical documentation, user manual for the corresponding medical device
- Label of medical device according to Decision No. 178/1999/QD-TTg dated August 30, 1999 of the Prime Minister and Circular No. 34/1999/TT-BTM dated December 15, 1999 of the Ministry of Trade.
NEW CIRCULATION NUMBER IS GRANTED FOR MEDICAL DEVICES IN THE FOLLOWING CASES:
- Medical devices for the first time requesting a circulation number;
- Medical devices that have been granted a circulation number but have one of the following changes: Type of medical device; manufacturing materials affecting the function of in vitro diagnostic medical devices and single-use medical devices;
- Medical devices that have been granted a circulation number but do not apply for renewal of the circulation number within the time limit specified in Clause 3, Article 27 of this Decree.
*THE APPLICATION FILE FOR NEW ISSUANCE IS DIVIDED INTO CASES AND TYPES OF DOCUMENTS REQUIRED AS FOLLOWS (stipulated in Article 26 of Decree 36/2016/ND-CP amended and supplemented by Point d Clause 13 Article 1 of Decree 169/2018/ND-CP):
>>> Application dossier for new circulation number for medical devices without corresponding national technical standards and Application dossier for new circulation number for medical devices that are measuring instruments but not subject to model approval under the regulations on metrology:
a) Request for new circulation number issuance in accordance with Form No. 04 specified in Appendix I enclosed with this Decree.
b) Medical device classification form in accordance with the form specified in Appendix V enclosed with this Decree.
c) Certificate of quality management system compliance still valid at the time of dossier submission.
d) Power of attorney from the medical device owner to the organization performing the circulation registration in accordance with the form specified in Appendix VI enclosed with this Decree, still valid at the time of dossier submission, except for the case specified in Point a, Clause 1, Article 21 of this Decree.
e) Certificate of sufficient warranty conditions issued by the medical device owner in accordance with the form specified in Appendix VII enclosed with this Decree, except for single-use medical devices as specified by the medical device owner or with documents proving that there is no warranty policy.
f) Free circulation certificate still valid at the time of dossier submission for imported medical devices.
g) Technical summary of the medical device in Vietnamese in accordance with Form No. 01 specified in Appendix VIII enclosed with this Decree, accompanied by technical documentation describing the functions and technical parameters of the medical device issued by the medical device owner.
Specifically for in vitro test kits, calibrators, and controls: technical documentation in Vietnamese in accordance with Form No. 02 specified in Appendix VIII enclosed with this Decree, accompanied by documentation on raw materials, product safety, manufacturing process, clinical and preclinical research reports including stability reports.
h) Common technical dossier following the guidelines in the ASEAN Agreement on Medical Devices.
i) Instructions for use of the medical device.
j) For Class C and D medical devices that are invasive to the human body: Summary of clinical trial data in accordance with the form specified in Appendix IX enclosed with this Decree, accompanied by clinical trial results, except for the following cases:
- Medical devices that have been circulated and granted a free circulation certificate by one of the following countries: EU member states, Japan, Canada, Australia (TGA), USA (FDA).
- Medical devices that were circulated before this Decree came into effect.
- Other cases as prescribed by the Minister of Health.
k) For Class C and D in vitro diagnostic medical devices, an additional inspection certificate is required as prescribed by the Minister of Health, except for the following cases:
- Medical devices that have been granted a free circulation certificate by one of the following countries: EU member states, Japan, Canada, Australia (TGA), USA (FDA).
- Medical devices that were circulated before this Decree came into effect.
l) The label to be used when circulating in Vietnam of the medical device.
m) Receipt of the dossier for public announcement of compliance with production conditions suitable for the product applying for circulation number registration for domestically produced medical devices.
n) Report on business results during the period of circulation number issuance in accordance with Form No. 01 specified in Appendix X enclosed with this Decree for medical devices that have been circulated before this Decree comes into effect and are exempt from submitting a summary of clinical trial data or an inspection certificate.
>>> Application dossier for new circulation number issuance for medical devices with corresponding national technical regulations:
a) Request for new circulation number issuance in accordance with Form No. 04 specified in Appendix I enclosed with this Decree.
b) Certificate of conformity; and documents from points b to o as specified for the application dossier for new circulation number issuance for medical devices without corresponding national technical regulations.
>>> Application dossier for new circulation number issuance for medical devices that are measuring instruments subject to model approval according to regulations on metrology:
a) Request for new circulation number issuance in accordance with Form No. 04 specified in Appendix I enclosed with this Decree.
b) Decision on model approval and documents
10. Requirements for New and Renewal Applications of Medical Device Circulation Numbers
The application package for a new or renewal application for a medical device circulation number must be in one set. All documents in the package must be clearly printed and arranged in the prescribed order.
Requirements for Certain Documents in the Application Package:
a. Certificate of Quality Management System Compliance:
- Submit the original, a certified copy, or a copy confirmed by the applicant for the circulation number.
- If the Certificate of Quality Management System Compliance is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with legal regulations.
b. Authorization Letter from the Medical Device Owner and Certificate of Warranty Eligibility:
- For domestically manufactured medical devices: Submit the original or a certified copy.
- For imported medical devices: Submit a copy legalized by the consular authority or a certified copy of the legalized copy.
c. Certificate of Free Circulation:
- Submit a copy legalized by the consular authority or a certified copy of the legalized copy.
- If the Certificate of Free Circulation is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with legal regulations.
- If the Certificate of Free Circulation does not specify an expiry date, the expiry date will be calculated as 36 months from the date of issuance.
d. Technical Documentation of the Medical Device:
- Submit a copy confirmed by the applicant for the circulation number.
- If the technical documentation is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with legal regulations.
e. Instructions for Use of the Medical Device:
Submit a Vietnamese version confirmed by the applicant for the circulation number.
f. Inspection Certificate:
Submit the original, a certified copy, or a copy confirmed by the applicant for the circulation number.
g. Label Sample:
Submit a sample label confirmed by the organization registered for circulation. The label must meet the prescribed requirements.
11. Agency for Medical Device Registration and Circulation
The Department of Medical Equipment and Facilities under the Ministry of Health is the agency responsible for issuing medical device circulation registration certificates.
12. Timeframe for Medical Device Registration and Circulation
In cases where there are no requests for amendments or supplements to the registration dossier, the Minister of Health is responsible for:
a) For medical devices without corresponding national technical regulations: Organizing the evaluation and issuing new circulation numbers within 60 days from the date on the dossier receipt slip. In cases where a new circulation number is not granted or an extension is not granted, a written response must be provided stating the reasons.
b) For medical devices with corresponding national technical regulations: Organizing the evaluation and issuing new circulation numbers within 15 days from the date on the dossier receipt slip. In cases where a new circulation number is not granted or an extension is not granted, a written response must be provided stating the reasons.
13. Validity of Medical Device Circulation Registration Certificate
According to Clause 1, Article 20 of Decree 36/2016/ND-CP on medical device management:
The circulation number of medical devices of types B, C, and D is valid for 05 years from the date of issuance. In cases where the medical device is granted an extension of the circulation number, the previously issued circulation number will be retained.
14. Cases where a new registration procedure or re-issuance of a medical device circulation number is not required
During the circulation of medical devices, when any of the following changes occur, the holder of the circulation number is responsible for sending a notification to the Ministry of Health within 10 working days:
- Change of address of the medical device owner or the holder of the medical device circulation number;
- Change of name of the holder of the circulation number. The holder of the circulation number must enclose with the notification documents proving the ownership of the medical device of the new owner.
- Change of one of the information about the name or address of the medical device manufacturing facility. The holder of the circulation number must enclose with the notification the following documents: Certificate of Free Circulation and Certificate of Compliance with Quality Management Standards valid at the time of dossier submission.
- Change of packaging for in vitro diagnostic medical devices. The holder of the circulation number must enclose with the notification the documents corresponding to the change.
- Change of warranty facility. The holder of the circulation number must enclose with the notification the documents as prescribed.
- Change of label or instructions for use but no change in indication: The holder of the circulation number must enclose with the notification the documents corresponding to the change.
15. Cases Where Medical Device Circulation Numbers Are Revoked
- Falsifying registration dossiers by the registration organization.
- The medical device has 03 batches recalled during the effective period of the circulation registration number, except for cases where the owner of the circulation number voluntarily recalls.
- The registration organization repairs or erases the contents of the circulation number, causing changes.
- The owner of the circulation number ceases operation or is no longer authorized by the owner of the medical device without a replacement organization.
- Medical devices circulated on the market do not ensure the quality registered for circulation.
- The circulation number is granted not in accordance with the prescribed authority, dossier, and procedures.
- Medical devices for which the owner of the circulation registration number or the distribution establishment does not have the prescribed commitment.
- Medical devices have expired according to regulations.
- Medical devices are manufactured at facilities that do not meet the prescribed conditions.
- The owner of the circulation number does not comply with the regulations at Point i, Clause 2, Article 66 of Decree 36/2016/ND-CP.
- Medical devices are classified incorrectly according to the regulations on medical device classification after the conclusion of the Ministry of Health.
16. Expedited Circulation Number for Medical Devices
Expedited issuance of new circulation registration numbers for medical devices in the following cases:
a) Medical devices that have been circulated in at least 02 of the following countries: Japan, Canada, Australia, the United States, and EU member countries;
b) Circulated in Vietnam before December 31, 2018 and meeting the following conditions:
- Circulated for at least 03 years out of the 05 years before the application submission date;
- No warning information related to the quality and safety of the medical device.
16.1. Procedures
Step 1: The applicant for a circulation number submits the application dossier to the Ministry of Health (Department of Medical Equipment and Facilities).
Step 2: Upon receiving a complete and valid application dossier, the Ministry of Health issues the applicant with a Receipt of Application for Circulation Number for Medical Equipment (Form No. 04) as prescribed in Appendix IV enclosed with Decree No. 36/2016/ND-CP.
If there is no request for amendment or supplementation of the registration dossier, the Minister of Health shall:
- Organize an appraisal to grant a new circulation number within 30 days from the date on the Receipt of Application. If a new circulation number is not granted, a written response must be issued stating the reasons.
- If the application dossier for a circulation number is incomplete, the Ministry of Health must issue a written notice to the applicant to supplement or amend the dossier, specifying which documents need to be supplemented and which content needs to be amended within 15 working days.
Step 3: Upon receiving the written request to supplement or amend the application dossier, the applicant must supplement or amend the dossier in accordance with the contents specified in the written request and submit it to the Ministry of Health. The date of receipt of the supplemented or amended dossier is recorded on the Receipt of Application;
- If the applicant has supplemented or amended the dossier but not in accordance with the requirements, the Ministry of Health will notify the applicant to continue completing the dossier in accordance with the regulations in Clause 4 of this Article;
- After 90 days from the date the Ministry of Health issues the request for supplementation, if the applicant does not supplement or amend the dossier, or if after 05 times of amending and supplementing the dossier from the date the Ministry of Health first requests the amendment and supplementation, the dossier still does not meet the requirements, the procedure for requesting a circulation number must be restarted;
- In the process of amending or supplementing the dossier, if the documents specified in points c, d, and e of Clause 1, Article 26 expire, the organization or individual applying for a circulation number must submit additional replacement documents that are still in effect. These documents must meet the requirements specified in Article 28 of Decree 36/2016/ND-CP.
Step 4: Within 03 working days from the date of granting the circulation number, the Ministry of Health is responsible for publicly disclosing the following information on the Ministry of Health's electronic portal:
a) Name, classification, manufacturing facility, and country of manufacture of the medical equipment;
b) Circulation number of the medical equipment;
c) Name and address of the owner of the medical equipment;
d) Name and address of the holder of the circulation number;
e) Name and address of the medical equipment warranty facility;
16.2. Conditions for Implementation
Article 21 of Decree No. 36/2016/ND-CP: Conditions for organizations to be named as the declarant of applied standards or to register for circulation of medical equipment
Organizations that can be named as the declarant of applied standards or to register for circulation of medical equipment include:
a) Enterprises, cooperatives, and business households of Vietnam that are owners of medical equipment;
b) Enterprises, cooperatives, and business households of Vietnam with the function of trading medical equipment that are authorized by the owner of medical equipment to register;
c) Representative offices in Vietnam of foreign traders that are the owners of medical equipment or are authorized by the owners of medical equipment.
Organizations named as the declarant of applied standards or to register for circulation of medical equipment must have a warranty facility in Vietnam or must have a contract with an organization with the capacity to warrant the medical equipment they are named to register, except for single-use medical equipment as prescribed by the owner of the medical equipment.
In the case of organizations named as the declarant of applied standards or to register for circulation of medical equipment under point c, Clause 1 of this Article, the owner of the medical equipment must have a contract with an organization with the capacity to warrant the medical equipment they are named to declare or register, except for single-use medical equipment as prescribed by the owner of the medical equipment.
The warranty facility must be certified by the owner of the medical equipment as having the capacity to warrant the product that the organization is named to apply for a circulation number.
Clause 2, Article 25. Forms of circulation registration
17. Medical Device Circulation Number Lookup
18. Required Documents
- Notarized copy of the Business Registration Certificate
- Notarized copy of the product classification result
- Quality Management Certificate
- Certificate of Free Circulation valid at the time of filing for imported medical devices;
- Summary technical description of the medical device in Vietnamese;
- Technical documentation (catalogue) describing the functions and technical specifications of the medical device;
- Instructions for use of the medical device;
- Sample of the label to be used for circulation in Vietnam of the medical device
19. Medical Device Registration License Application Consulting Service by Thiên Di
- Consulting on regulations, documents, and procedures of current laws on medical device licenses;
- Guide customers in applying for medical device licenses;
- Draft and submit documents on behalf of customers when necessary and submit to the competent state agency;
- Monitor and receive results from the competent state agency and hand them over to customers
20. Reasons to choose Thiên Di's services:
Enthusiastic and timely customer support in all situations.
Our team consists of:
Experienced and professional experts and staff.
Regularly updated on new regulations and policies.
Continuously trained to improve professional skills and work experience.
Capable of handling high work pressure.
Always dedicated to self-improvement and professionalism, aiming for absolute customer satisfaction.
Human Resources
Human resources are the key to the success of any business. Therefore, Thien Di always focuses on building and developing a professional, serious, and customer-friendly human resource team - which has been the compass for our success over the past time.
Thien Di provides services for medical equipment import procedures, medical equipment classification services, application for medical equipment import licenses, import licenses for medical equipment, etc. in Vietnam. Currently, we provide this service in most provinces and cities across the country, completing the application and procedures on behalf of clients to submit to state agencies, so clients will not have to spend time doing administrative procedures.
Contact us today to learn more about our services or to request a free consultation.
Contact Info:
THIEN DI TRADING SERVICES COMPANY LIMITED
Address: No. 36 Street A4, Ward 12, Tan Binh District, Ho Chi Minh City
Hotline: 0981317075
Phone: 028.6293 9377
Email: info@luatthiendi.com
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