Certificate of free sale for medical devices class C, D in Vietnam

Certificate of free sale for medical devices class C, D in Vietnam

I. Circulation number of medical devices in Vietnam

1 . The circulation number of the medical device is the number of certificates of free sale for medical devices class C, D.
2 . The free-sale registration number holder is an organization that has been granted a certificate of free sale for medical devices.
3 . Validity of the free-sale registration number: the free-sale registration number of medical devices is valid for an indefinite period.

II. Conditions for sales of medical devices class C, D on the market in Vietnam

1. A medical device may be placed on the market if it meets the following conditions:
a) It has been granted registration number, marketing authorization number, certificate of
registration or import license in accordance with regulations on management of medical devices or in the cases specified in Point d Clause 2 Article 76 of this Decree, except the following cases:
- The medical device is liquidated as prescribed by laws;
- The medical device reaches its expiry date;
- The defect that is harmful to users’ health cannot be repaired as prescribed in Clause 4 Article 34 of this Decree;
- The use of medical device is prohibited by a regulatory authority.
b) Its label contains adequate information in accordance with regulations of law on labeling of goods;
c) Instructions for use of the medical device are given in Vietnamese language;
d) Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.

2. If the import license is available as prescribed in Points a, b, c, d and dd Clause 1 Article 48 of this Decree, the satisfaction of the condition in Point d Clause 1 of this Article is not required.

3. If the information specified in Point c and Point d Clause 1 of this Article is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.

III. Conditions for issuance of circulation registration certificates for medical devices class C, D in Vietnam.

1 . Conditions for issuancing circulation registration certificates for medical devices:
a ) Manufactured at a production facility that has declared its eligibility for domestically produced medical devices;
b ) Produced at a production facility that has been granted a certificate of ISO 13485 quality management standard and circulated in any country in the world for imported medical devices;
c ) Compliant with national technical regulations or standards announced by the manufacturer to apply.

2 . Do not allow to repeat procedures applicable standards published or registered for circulation for medical devices in one of the following cases:
a ) Medical devices in the cases specified in Clause 1, Article 37 of this Decree;
b ) medical devices is recovered in cases stipulated in paragraphs 1 and 3 of Article 38 of this Decree.

3 . Do not receive the application for publication of applicable standards or registration for free sale within 12 months from the date of issuance of a decision on revocation of the free-sale registration number for medical devices falling into one of the cases specified in Clause 1 of this Article. Clause 2, Article 38 of this Decree.

IV. Cases exempt from registration of circulation in Vietnam.

1. Medical devices is only for the purposes of research, testing, inspection, testing, testing, quality assessment, training in the use and repair of medical devices.

2 . Medical devices imported into Vietnam for the purpose of aid or healthcare Humanitarian or service activities fairs, exhibitions, displays, product introduction or to use for the purpose of gifts gifts, gifts for the medical establishment or individual treatment, personal characteristics or special diagnostic needs of medical facilities.

3 . Medical devices without a free-sale registration number imported to meet the urgent needs of disease prevention and control, and to overcome consequences of natural disasters and catastrophes, for which there are no other capable medical devices available on the market for replace.

4 . Medical devices manufactured in Vietnam for export purposes only or participating in exhibitions, fairs and exhibitions abroad.

V. Conditions of organizations entitled to register for circulation of medical devices class C, D in Vietnam.

1 . Organization names are registered for sales of of medical devices include:
a ) enterprises, cooperatives, business households in Vietnam are owners of medical devices;
b ) Vietnamese enterprises, cooperatives and business households authorized by the owner of the medical devices;
c ) The representative office permanently residing in Vietnam of a foreign trader that is the owner of the medical devices or authorized by the owner of the medical devices.

2 . The organization registering the free sale of medical devices must have a warranty facility in Vietnam or must have a contract with a qualified organization to provide warranty for medical devices, except for the following cases: The case of single-use medical devices as specified by the owner of the medical device or with documents proving that there is no warranty.
In case the organization in whose name registers the free sale of medical devices specified at Point c, Clause 1 of this Article, the owner of the medical devices must have a warranty facility in Vietnam. or have a contract with a qualified facility to provide warranty for medical devices, except for the case of single-use medical devices as prescribed by the owner of the medical devices or with documents proving that no warranty.
The warranty facility must be certified by the medical devices owner to be qualified to warrant the product

VI. Forms of registration for sales of medical devices class C, D in Vietnam

1 . The issuance of a new free-sale registration number applies to medical devices in the following cases:
a ) Medical devices that is applied for a free-sale registration number for the first time.
b ) Medical Devices has been granted circulation but have one of the following changes:
- Owners of medical devices; type of medical devices; types, purposes of use, indications for use; quality standards; additional production facilities and product codes; manufacturing materials that affect the function of in vitro diagnostic medical devices and disposable medical devices; concentration, content and composition of ingredients that are
pharmaceutical ingredients combined in a medical device with the role of supporting treatment purposes;
- Not falling into the cases specified in Clause 7 Article 32 of this Decree.

2 . Fast new level of circulation for medical devices in one of the following cases:
a ) Has been granted a certificate of free sale by one of the following organizations or countries or a market
authorization (hereinafter referred to as the circulation certificate): United States Food and Drug Administration (FDA) -
USA; Therapeutic Goods Administration (TGA) - Australia; Health Canada (Health Canada); Japan”s Ministry of Health,
Labor and Welfare (MHLW) or Medicines and Medical Devices Agency (PMDA) - Japan, EU member states, UK, Switzerland; National Medical Products Administration (NMPA) - China; The Ministry of Food and Drug Safety (MFDS) -
Korea or on the list of marketing authorization organizations recognized by the competent authorities of Vietnam
(hereinafter referred to as countries for short). reference);
b ) has been granted import permits or certificates in circulation or registered for circulation in the form of trade in
Vietnam, except for the cases was revoked before the date of effectiveness of this Decree;

3 . Urgently issue new free-sale registration numbers for medical devices in service of epidemic prevention and control, and to overcome consequences of natural disasters and disasters in urgent cases on the List promulgated by the Minister of Health and belong to the Ministry of Health. one of the following cases:
a ) Has been approved for circulation or emergency use by one of the reference countries;
b ) on the list of products used by emergency World Health Organization (WHO) announced;
c ) Belonging to the list of popular products announced by the European Health Security Committee (EUHSC);
d ) Having been granted a free-sale registration number or granted a commercial import license in Vietnam, except
for the cases in which it was revoked before the effective date of this Decree;
e) To be produced domestically in the form of technology transfer for medical devices in one of the cases specified in points a, b, c or d of this paragraph;
e ) Being domestically produced in the form of processing for medical devices falling into one of the cases
specified at Points a, b, c or d of this Clause.

VII. Dossier of application for a new free-sale registration number of Medical Devices class C, D in Vietnam.

1 . Records suggest new level of circulation for medical devices with technical regulations and the respective countries:
a ) A written request for a new circulation number.
b ) Certificate standard ISO 13845 quality management in force at the time of filing.
c ) The power of attorney of the owner of the medical devices for the establishment conducting the free sale registration is still valid at the time of application submission, except for the case specified at Point a, Clause 1, Article 25 of this Decree.
d ) A certificate of eligibility for warranty issued by the owner of the medical devices, unless the medical devices is for single use as prescribed by the owner of the medical devices or there are documents proving it. I have no warranty.
dd) The certificate of free sale is valid at the time of submission of the application for imported medical devices.
e ) General technical dossiers on medical devices according to ASEAN regulations (hereinafter referred to as CSDT dossiers).
g) Certificate of conformity.

2 . Dossier of application for a new free-sale registration number for medical devices that is a measuring instrument subject to sample approval in accordance with the law on measurement:
a ) A written request for a new circulation number.
b ) Sample approval decision.
c ) Papers prescribed at Points b, c, d, e and f, Clause 1 of this Article.

3 . Records suggest new level of circulation for medical devices under emergency cases quickly prescribed in Clause 2, Article 29 of this Decree:
a ) A written request for a new circulation number.
b ) Papers prescribed at Points b, c and d, Clause 1 of this Article.
c ) The circulation certificate is issued by one of the reference countries for the case specified at point a, clause 2,
Article 29 of this Decree.
d ) The certificate of free sale for imported medical devices and the import license or the free-sale registration number or the certificate of free-sale registration for the case specified at Point b, Clause 2, Article 29 of this Decree.
dd) A quality assessment certificate issued by a competent Vietnamese authority for in vitro diagnostic medical devices, except for the following cases:
- Belonging to lists A, B, Appendix 2 to the Agreement on in vitro diagnostic medical devices in Europe and have been granted a certificate of free sale (Certificate of Free Sale) of one of the EU member countries. , England, Switzerland;
- Belonging to lists A and B, Appendix 2 to the Agreement on in vitro diagnostic medical devices in Europe and have been granted a certificate of sale (Market Authorization) of one of the reference countries;
- Not on the list A, B, Appendix 2 to the Agreement on in vitro diagnostic medical devices in Europe but has been
granted a certificate of sale (Market Authorization) of one of the reference countries;
- Belonging to the list announced by the Minister of Health.
e ) CSDT file.

4 . Dossier of application for a new free-sale registration number for emergency medical devices specified in Clause 3, Article 29 of this Decree:
a ) A written request for a new circulation number.
b ) Papers prescribed at Points b, c and d, Clause 1 of this Article.
c ) Certificate of circulation or license for emergency use for imported medical devices.
d ) Technology transfer contract, for the case specified at point dd, clause 3, Article 29 of this Decree.
dd) Processing contract, for the case specified at Point e, Clause 3, Article 29 of this Decree.
e ) A certificate of product quality inspection or assessment of one of the units on the list published on the website
of the Ministry of Health if it falls into one of the following cases:
- Domestically produced medical devices;
- Medical devices that has been authorized by competent authorities in EU member states, the UK, and
Switzerland for circulation and emergency use, but is not on the list of popular products issued by the Health Security
Commission. published by the European Health Security Committee (EUHSC).
g) Dossier of CSDT.

5 . Dossier of application for a new free-sale registration number for other medical devices:
a ) A written request for a new circulation number.
b ) Papers specified at Points b, c, d and dd Clause 1 of this Article.
c ) Result of appraisal of medical records of the unit appointed by the Minister of Health together with the dossier of medical records.
d ) For medical devices in vitro diagnostic reagents, quality calibration, control materials must have more quality certificate issued by the competent authorities of Vietnam.
dd) For chemicals and preparations with only one purpose of sterilizing medical devices, there must be an additional test sheet of ingredients and content of substances with disinfectant activity of the unit that has announced the eligibility for food. currently testing according to the provisions of the law on management of chemicals, insecticidal and germicidal preparations used in household and medical fields; Test sheet to evaluate the biological effectiveness of the product and the product”s side effects for the test participants of the unit that has announced the eligibility to conduct the test in accordance with the law on chemical management , insecticidal and germicidal preparations used in household and medical fields.

VIII. Requirements for application for a new free-sale registration number

1 . Requirements for some papers in the application for registration of circulation:
a ) For the certification standards of quality management: Submit original or certified copy or copies certified by the proposals in circulation numbers.
In case the certificate of satisfaction of quality management standards is not in English or in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
b ) For the power of attorney of the owner of the medical devices and the certificate that the facility is eligible for
warranty:
- For domestically produced medical devices: Submit the original or a certified copy;
- For imported medical devices: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.
c ) For circulation papers: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.
In case the circulation paper is not in English or not in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
d ) For the certificate of quality assessment, test sheet, test sheet and appraisal results of CSDT dossier: Submit the original or a certified true copy or a certified copy of the applicant establishment. circulate.
dd) For CSDT dossier: Submit a copy certified by the organization requesting the issuance of a free-sale registration number. In case the CSDT dossier is not in English or not in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.

2 . Requirements for some papers in the application for registration of circulation in case of emergency are specified in Clause 3, Article 29 of this Decree:

Documents issued by foreign countries must be consular legalized, in case there is no consular legalization:
a ) For the letter of authorization, the original must be provided with confirmation information.
b ) For the papers specified at Point c, Clause 4, Article 30 of this Decree, a link to search for the circulation and use of medical devices must be provided from the website of the licensing agency, enclosed with the document. The copy provides information on the search link of the organization applying for the circulation number. The results of searching for information on the circulation license on the website must include at least the following information in English:
name; species; manufacturer and country of manufacture.

IX. Receipt and evaluation of application for registration of free sale of medical devices class C,D in Vietnam.

1 . Organizations applying for free-sale registration numbers shall submit dossiers to the Ministry of Health through the electronic portal on management of medical devices.

2 . For registration documents circulated medical devices specified in paragraphs 1 and 2 of Article 30 of this Decree:
a ) If there is no request to amend or supplement the application for registration of circulation, the Minister of Health is responsible for: Organize the appraisal to issue a free-sale registration number within 30 days from the date of receipt of the application. complete and valid documents (including papers certifying that the fee for assessment and issuance of a circulation permit has been paid in accordance with regulations of the Ministry of Finance). In case of refusal to issue a free-sale registration number, there must be a written reply clearly stating the reason.
b ) Where the registration documents for circulation unfinished, the Ministry of Health must inform the organization applying for circulation to supplement or amend registration documents circulated, stating specifically the tonic supplementing these materials, the content need to be amended within 25 days from the date of receipt of valid complete documents.
c ) When receiving a request for addition or modification of the application file for a free-sale registration number, the applicant establishment must supplement or amend the information according to the notified information and send it to the Ministry of Health.
In case the establishment applying for a free-sale registration number has added or modified its dossier but it is not in accordance with the requirements, the Ministry of Health will notify the establishment to continue to complete the dossier according to the provisions of Point b, Clause 2 of this Article.
After 90 days from the date the Ministry of Health issues a notice of the request, but the establishment 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 requests the amendment, If the application is supplemented for the first time but still does not meet the requirements, the procedure for applying for a free-sale registration number must be repeated from the beginning.

3 . For registration documents circulated medical devices specified in paragraph 3 of Article 30 of this Decree:
a ) In case there is no request to amend or supplement the application for circulation registration, the Minister of Health is responsible for: Organize the appraisal to issue a free-sale registration number within 10 working days from the  date of receipt of the registration number. complete and valid dossiers (including papers certifying payment of fees for assessment and issuance of circulation permits according to regulations of the Ministry of Finance). In case of refusal to issue a free-sale registration number, there must be a written reply clearly stating the reason.
The Ministry of Health only appraises the legal documents specified at Points b, c, d and dd, Clause 1, Article 30 of this Decree. As for other contents, the organization applying for a free-sale registration number is responsible for the accuracy and legality of these documents. The Ministry of Health shall post-check these contents after the issuance of a free-sale registration number.
b ) In case the application for registration of circulation is incomplete, the Ministry of Health must notify the organization requesting the issuance of a free-sale registration number to supplement or amend the application for registration of circulation, specifying the additional information. which documents and contents need to be amended within 10 working days from the date of receipt of a complete and valid dossier.
“c) The applying organization shall comply with the request for modification and send modified documents to the Ministry of Health as requested.
If the modified application is still unsatisfactory, the Ministry of Health shall continue sending a request for modification to the applying organization as prescribed in Point b Clause 3 of this Article.
If the applying organization fails to provide the modified application within 90 days from the receipt of the Ministry of Health’s request for modification or the application is still unsatisfactory after 03 modification times, the application shall be rejected.”.

4 . For the application for registration of free sale of medical devices specified in Clause 4, Article 30 of this Decree:
a ) In case there is no request to amend or supplement the application for circulation registration, the Minister of Health is responsible for: Organize the appraisal to issue a free-sale registration number within 10 working days from the date of receipt of the registration number. complete and valid dossiers (including papers certifying payment of fees for assessment and issuance of circulation permits according to regulations of the Ministry of Finance). In case of refusal to issue a free-sale registration number, there must be a written reply clearly stating the reason.
The Ministry of Health only appraises legal documents specified at Points b, c, d, dd and e, Clause 4, Article 30 of this Decree. As for other contents, the organization applying for a free-sale registration number is responsible for the accuracy and legality of these documents. The Ministry of Health shall post-check these contents after the issuance of a free-sale registration number.
b ) In case the application for registration of circulation is incomplete, the Ministry of Health must notify the organization requesting the issuance of a free-sale registration number to supplement or amend the application for registration of circulation, specifying the additional information. which documents and contents need to be amended within 08 working days from the date of receipt of complete and valid dossiers.
c ) When receiving a request for addition or modification of the application file for a free-sale registration number, the applicant establishment must supplement or amend the information according to the notified information and send it to the Ministry of Health.
In case the establishment applying for a free-sale registration number has added or modified its dossier but it is not in accordance with the requirements, the Ministry of Health will notify the establishment to continue to complete the dossier according to the provisions of Point b, Clause 4 of this Article. this.
After 90 days from the date the Ministry of Health issues a notice of the request, if the establishment does not supplement or amend the dossier, it must repeat the procedure for applying for a free-sale registration number from the beginning.

5 . For registration documents circulated medical devices specified in Clause 5 of Article 30 of this Decree:
a ) In case there is no request to amend or supplement the application for registration of circulation, the Minister of Health is responsible for: Organize the appraisal to issue a free-sale registration number within 45 days from the date of receipt of the application. complete and valid documents (including papers certifying that the fee for assessment and issuance of a circulation permit has been paid in accordance with regulations of the Ministry of Finance). In case of refusal to issue a free-sale registration number, there must be a written reply clearly stating the reason.
b ) Where the registration documents for circulation unfinished, the Ministry of Health must inform the organization applying for circulation to supplement or amend registration documents circulated, stating specifically the tonic supplementing these materials, the content need to be amended within 40 days from the date of receipt of valid complete documents.
c ) When receiving a request for addition or modification of the application file for a free-sale registration number, the applicant establishment must supplement or amend the information according to the notified information and send it to the Ministry of Health.
In case the establishment applying for a free-sale registration number has added or modified its dossier but it is not in accordance with the requirements, the Ministry of Health will notify the establishment to continue to complete the dossier according to the provisions of Point b, Clause 5 of this Article. this.
After 90 days from the date the Ministry of Health issues a notice of the request, but the establishment 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 requests the amendment, If the application is supplemented for the first time but still does not meet the requirements, the procedure for applying for a free-sale registration number must be repeated from the beginning.

6 . Within 01 working day from the date of issuance of the free-sale registration number, the Ministry of Health is responsible for publishing on the electronic portal on management of medical devices the following information:
a ) The name, classification, production facilities, domestic production of medical devices;
b ) The circulation number of the medical devices;
c ) Name and address of the owner of the medical devices;
d ) The name and address of the owner of circulation;
dd) Name and address of the medical devices warranty establishment;
e ) The documents in circulation registration dossier of medical devices, except for the documents specified at
Point f, Clause 1 and Clause 5, Article 30 c;
g) Purpose of use of the medical devices.

7 . During the circulation of medical devices, the registration number holder is responsible for making a written
notice of the change enclosed with documents related to the change and updating such documents in the registration file.
circulated publicly on the Medical Devices Management Portal within 10 working days from the date of one of the
following changes:
a ) Change of address of the owner of the medical devices or the owner of the free sale number of the medical devices;
b ) Changing the name of the owner of the circulation or the name of the owner of medical devices;
c ) Change one of the information about: name, address of the medical devices manufacturer;
d ) Change of packing specifications;
dd) Change of warranty facility;
e ) Change the label, change the instructions for use but do not change the purpose of use, indications for use, features and performance of the medical devices. Medical devices manufactured before the date of notification of the change of label by the holder of the registration number shall be circulated with registered and updated information at the
time of manufacture.

Sources:
- Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical devices management.
- Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government on adjusting Decree No. 98/2021/ND-CP

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