Decree No. 07/2023/ND-CP amends and supplements some articles of Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on medical equipment management.

DECREE

Amending and supplementing certain articles of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical equipment management.

Pursuant to the Law on Government Organization on June 19, 2015; the Law Amending and Supplementing Certain Provisions of the Law on Government Organization and the Law on Local Administration Organization on November 22, 2019;

At the proposal of the Minister of Health,

The Government promulgates this Decree amending and supplementing certain articles of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical equipment management.

Article 1. Amend and supplement certain articles of Decree No.98/2021/NĐ-CP dated November 8, 2021 of the Government on management of medical equipment

1. Amending and supplementing Clause 2 Article 21 as follows:

“2. The owner of the circulation number is the organization that publishes the standard applicable to medical equipment or the organization that has been granted registration certificate for circulation of medical equipment according to the provisions of this Decree.”

2. Amending and supplementing Article 22 as follows:

“Article 22. Conditions for circulation of medical equipment

1. Medical equipment when circulating on the market must meet the following conditions:

a) Having a circulation number, registration number for circulation, registration certificate for circulation, import permit according to the regulations on medical equipment management or in the case provided for at point d clause 2 Article 76 of this Decree, except for the following cases:

- Being liquidated as prescribed by law;

- Expiring the product's shelf life;

- Not being able to correct the defect causing adverse effects on the health of users as stipulated in clause 4 Article 34 of this Decree;

- When the competent state authority does not allow its use.

b) Having a label with complete information as prescribed by current laws on product labeling;

c) Having user instructions for medical equipment in Vietnamese;

d) Having information about the warranty provider, warranty conditions, and duration; except in the case where the medical equipment is single-use as prescribed by the owner of the medical equipment or there is documentation proving that there is no warranty system.

2. In the case of having an import permit as prescribed at points a, b, c, d, and e clause 1 Article 48 of this Decree, it is not required to meet the condition prescribed at point d clause 1 of this Article.

3. In the case where the information prescribed at points c and d clause 1 of this Article is not attached to the medical equipment, it must be provided in electronic form and clearly indicate how to access the information on the medical equipment label.”

3. Amending and supplementing point c clause 3 Article 32 as follows:

“c) When receiving a request to amend and supplement the application for a circulation number, the organization applying for the circulation number must amend and supplement according to the contents already notified and submit to the Ministry of Health.

If the organization applying for the circulation number has amended and supplemented the application but not in accordance with the requirements, the Ministry of Health will notify the organization applying for the circulation number to continue completing the application in accordance with point b clause 3 of this Article.

After 90 days from the date the Ministry of Health issues a notification requesting amendments and supplements, if the organization applying for the circulation number does not amend and supplement the application or if after three rounds of amendments and supplements from the date the Ministry of Health first requests amendments and supplements, the application still does not meet the requirements, then the entire application process for the circulation number must be restarted.”

4. Amending and supplementing clause 6 Article 37 as follows:

“6. In the case where the Ministry of Health has issued a document not allowing continued circulation of medical equipment as prescribed in clause 5 of this Article, the owner of the circulation number or the distributor shall be responsible for recalling the medical equipment currently circulating in the market, except for medical equipment sold to healthcare facilities or end-users.”

5. Renaming Section 5 of Chapter V is as follows:

"Section 5. WITHDRAWAL OF REGISTRATION NUMBERS FOR MEDICAL DEVICES AND HANDLING OF MEDICAL DEVICES WITH WITHDRAWN REGISTRATION NUMBERS"

6. Add Clause 14 as follows: Article 38 as follows:

“14. The components of the registration dossier for medical devices that the competent authority concludes do not comply with the provisions of the law.”

7. Add Clause 6 as follows: Article 39 as follows:

“6. Upon receiving the conclusion of the competent authority as stipulated in Clause 14 of Article 38 of this Decree, within five working days from the date of receipt of the document from the competent authority, the registration number issuing agency shall examine and issue a document to withdraw the registration number under its management authority.

After issuing the document to withdraw the registration number, the competent authorities shall implement the procedures as prescribed in Clauses 3 and 4 of this Article.”

8. AddArticle 39a as follows:

"Article 39a. Handling of Medical Devices after Withdrawal of Registration Numbers

1. Medical devices sold to healthcare facilities or users may continue to be used until they are liquidated according to the law or until the expiration date of the product, except for medical devices that cannot be remedied due to factors causing adverse effects on user health as stipulated in Clause 4 of Article 34 of this Decree.

2. In cases where medical devices with withdrawn registration numbers have not been sold to users or healthcare facilities, the registration number holder must stop circulating the medical devices and take measures to recall them.”

9. Amend Article 44 as follows:

"Article 44. Price Display for Medical Devices

1. Organizations and individuals producing and trading in medical devices shall display prices for medical devices at locations as prescribed in Article 17 of Decree No. 177/2013/NĐ-CP dated November 14, 2013 of the Government detailing and guiding the implementation of certain provisions of the Law on Prices, or on the Ministry of Health’s online portal.

2. In cases where prices for medical devices are displayed on the Ministry of Health’s online portal, the following minimum information must be provided:

a) Name and type of medical device;

b) Manufacturer and country of production; owner and country of ownership;

c) Unit of measurement;

d) Configuration and technical features of the medical device;

đ) Displayed price of the medical device.”

10. Amend Article 45 as follows:

"Article 45. Price Declaration for Medical Devices

1. Organizations and individuals producing and trading in medical devices must declare prices; the content of the declaration, procedures for declaring prices for medical devices shall be implemented in accordance with the law on prices.

2. Based on actual circumstances and when there are abnormal price fluctuations affecting the supply of medical devices, the purchasing power of buyers, and the payment capacity of the Health Insurance Fund, the Minister of Health shall promulgate, update, amend, and supplement the list and guidelines for information on medical devices that must be declared.

3. Organizations and individuals producing and trading in medical devices shall declare prices for medical devices in accordance with the forms prescribed by the law on prices or on the Ministry of Health’s online portal.”

11. Amend and Supplement Article 46 is as follows:

"Article 46. Principles for managing the export and import of medical equipment

1. Organizations and individuals conducting the export and import of medical equipment must comply with the conditions stipulated by laws on export and import and shall be responsible for ensuring the quality, quantity, type, and intended use of the medical equipment they export or import.

2. Medical equipment that has been registered for circulation in Vietnam can be exported or imported according to demand without a limit on quantity and without approval from the Ministry of Health.

3. Medical equipment falling under the cases specified in Clause 1, Article 48 of this Decree when imported for use in Vietnam must have an import permit.

4. Medical equipment not falling under the cases specified in Clauses 2 and 3 of this Article when brought into Vietnam through other forms shall be carried out in accordance with the provisions of laws on foreign trade management.

5. The issuance of certificates of free circulation applies to medical equipment in accordance with the provisions of laws on foreign trade management.

6. The importation of used medical equipment shall be carried out in accordance with the provisions of laws on foreign trade management."

12. Amending and supplementing Article 48 as follows:

a) Amending Point e Clause 1 of Article 48 as follows:

"e) Medical equipment that has not yet been registered for circulation and is imported for use at healthcare facilities funded from official development assistance (ODA) and concessional loans, non-refundable aid not included in ODA, shall not fall under the scope of such support."

b) Supplementing Point o Clause 2 of Article 48 as follows:

"o) For cases of importation as prescribed in Point e Clause 1 of this Article, the application for an import permit must include the following additional documents:

- Original or certified copy of the Decision approving the investment orientation and the Investment Decision for the investment project or the Decision approving the technical assistance project documentation, project costs, or non-refundable aid not included in ODA, specifying the content of importing medical equipment;

- Original or certified copy of the contract for supplying medical equipment to the project;

- Power of attorney from the owner of the medical equipment to the organization applying for the import permit, which remains valid at the time of submission of the application. Submit the legalized version or certified copy of the legalized version;

- Certificate of warranty capability issued by the owner of the medical equipment, except in cases where the medical equipment is single-use as defined by the owner of the medical equipment or there is evidence showing no warranty system. Submit the legalized version or certified copy of the legalized version;

- Valid registration certificate for the medical equipment at the time of submission of the application. Submit the legalized version or certified copy of the legalized version. In cases where the registration certificate is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the law."

13. Amending Clause 3 of Article 52 as follows:

"3. Implement price listing and declaration of prices for medical equipment in accordance with this Decree and the provisions of laws on pricing."

14. Supplementing Clause 12 Article 66 is as follows:

"12. In cases where the procedures stipulated in this Decree involve confidential documents as prescribed by law, the related confidential materials concerning the licensing procedure shall be submitted directly and stored according to the confidential regime."

15. Amend and supplement Article 70 as follows:

a) Amend and supplement Clause 5 of Article 70 as follows:

"5. Publish publicly on the Ministry of Health's electronic portal information about:

a) The winning bid prices for medical equipment procurement by state health facilities nationwide;

b) The list of medical equipment that has been recalled from circulation;

c) The list of organizations and individuals who have falsified documents and violated regulations on managing medical equipment as stipulated in this Decree."

b) Amend and supplement Clause 7 of Article 70 as follows:

"7. Take the lead and coordinate with relevant state management agencies to organize inspections, examinations, handle complaints and denunciations, and deal with violations of laws in the field of medical equipment as prescribed in this Decree and in accordance with the law."

c) Supplement Clause 13 and Clause 14 Article 70 as follows:

"13. Announce and adjust the list of medical equipment required to declare prices based on management requirements and actual conditions.

14. Issue guidelines for information on medical equipment required to declare prices."

16. Amend and supplement Clause 5 of Article 73 as follows:

"5. Be responsible for organizing and implementing procedures as prescribed in this Decree; organize inspections, examinations, handle complaints and denunciations, and deal with violations of laws in the field of medical equipment and pricing of medical equipment within the province in accordance with the law."

17. Amend and supplement Article 74 as follows:

a) Amending Point o of Clause 3 of Article 74 as follows:

"o) Implement price posting and declaration of medical equipment in accordance with this Decree and the law on pricing."

b) Supplement Clause 5 Article 74 as follows:

"5. Responsibilities of organizations and individuals when submitting applications for procedures prescribed in this Decree:

a) Bear legal responsibility for the legality and accuracy of the documents and materials submitted in the application;

b) Ensure consistency and uniformity of information on medical equipment between the application document and the initial permit application file with supplementary files requested by the competent authority;

c) Ensure that the documents and materials in the application remain valid throughout the process;

d) Bear responsibility for retaining the documents and materials submitted in the application."

18. Amend and supplement Article 76 as follows:

Article 76. Transitional Provisions

1. Applications for registration numbers submitted in accordance with Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management, which was amended and supplemented by Decree No. 169/2018/NĐ-CP and Decree No. 03/2020/NĐ-CP (hereinafter referred to as Decree No. 36/2016/NĐ-CP), before January 1, 2022, until the effective date of this Decree, will be handled as follows:

a) For applications for registration numbers of Class B medical equipment, the Ministry of Health will guide enterprises that have submitted applications to review and implement the announcement of applicable standards in accordance with this Decree without having to resubmit the fee for registration number issuance;

b) For applications for registration numbers of Class C and D medical equipment that meet the conditions stipulated in Clause 3 of Article 30 of this Decree, the Ministry of Health will issue registration numbers in accordance with the procedures stipulated in Article 32 of this Decree;

c) Use the classification results of medical equipment announced by qualified classification organizations before the effective date of this Decree in the application for registration numbers.

2. Regulations on the validity of import permits; regulations on importing medical equipment not included in the list requiring import permits:

a) Import permits for non-in vitro diagnostic medical equipment issued from January 1, 2018 to December 31, 2021 will continue to be valid until December 31, 2024;

b) Import permits for in vitro diagnostic medical equipment issued from January 1, 2018 to December 31, 2021 will continue to be valid until December 31, 2024 and there is no limit on the quantity imported;

c) Organizations that have obtained import permits under points a and b of this clause must comply with legal requirements and bear responsibility for ensuring the quality, quantity, type, and intended use of imported medical equipment. The Ministry of Health is responsible for conducting inspections, examinations, and revoking import permits for cases violating medical equipment management regulations;

d) Medical equipment not included in the list requiring import permits (except chemicals, insecticides, disinfectants used solely for sterilizing medical equipment in household and medical fields) and classified as Class C or D medical equipment with published information on the Ministry of Health's electronic portal can continue to be imported until December 31, 2024 without quantity limits, without needing confirmation from the Ministry of Health as medical equipment, and not dependent on the time of publication on the Ministry of Health's electronic portal when performing customs clearance procedures.

Organizations and individuals importing medical equipment must declare information about the issuance document of the classification result of medical equipment they have conducted or requested a qualified organization to conduct and bear responsibility for ensuring the quality, quantity, type, and intended use of imported medical equipment.

Customs authorities will check and compare the information in the issuance document of the classification result of medical equipment declared by organizations and individuals importing medical equipment on the Ministry of Health's electronic portal.

3. Regulations on the validity of registration numbers, certificates of registration numbers, and registration numbers:

a) The number of circulation permits issued in accordance with the provisions of Decree No. 36/2016/NĐ-CP before January 1, 2022 shall remain valid indefinitely;

b) The registration certificate for circulation of medical devices produced domestically that were issued before January 1, 2022 shall be valid until the expiration date indicated on the registration certificate for circulation;

c) The circulation registration number for in vitro diagnostic medical devices that were issued from January 1, 2014 to December 31, 2019 shall continue to be valid until December 31, 2024;

d) In vitro diagnostic medical devices that were issued a circulation registration number from January 1, 2020 to December 31, 2021 shall be valid until the expiration date indicated on the registration certificate for circulation;

đ) Organizations that have been issued circulation registration certificates and numbers as specified in points b, c, and d of this clause must comply with the legal requirements and bear responsibility for ensuring the quality, quantity, types, and intended use of medical devices. The Ministry of Health shall be responsible for inspecting, supervising, and revoking circulation registration certificates and numbers for organizations that violate regulations governing medical devices management;

4. For organizations importing medical devices that submitted applications for import permits before January 1, 2022 but have not yet received such permits;

The Ministry of Health shall be responsible for notifying and guiding enterprises to complete the application documents to obtain circulation numbers in accordance with the provisions of Decree No. 98/2021/NĐ-CP and shall give priority consideration; if there is a continued need to apply for an import permit based on the previously submitted application, the Ministry of Health shall issue the import permit according to the procedures and formalities stipulated in point c of this clause if the submitted application contains all required components and meets the requirements set forth in points a or b of this clause;

a) The application documents for obtaining an import permit for medical devices listed in the category requiring import permits issued by the Minister of Health include:

- A request for issuance of an import permit;

- A free circulation certificate for imported medical device types still in effect (original or certified copy);

- An ISO 13485 quality management standard certification from the manufacturer still in effect (original or certified copy confirmed by the organization applying for import);

- An authorization letter from the owner of the medical device granting the organization or individual the right to import the medical device still in effect (original or certified copy);

- Technical documentation describing the imported medical device type in Vietnamese (confirmed by the organization applying for import);

- Technical documentation (catalogue) detailing the functions and technical specifications of the imported medical device type;

- Clinical evaluation documentation and user guide documentation from the owner or manufacturer for medical devices that are types of equipment or materials that intervene in the body in cardiovascular and neurosurgery specialties;

b) The application documents for obtaining an import permit for in vitro diagnostic reagents include:

- Import order;

- Free circulation certificate still in effect (original or certified copy);

- An ISO 13485 quality management standard certification from the manufacturer still in effect (original or certified copy confirmed by the organization applying for import);

- Quality control standards and testing methods for medical devices (confirmed by the organization applying for import);

- Labels and user guides in Vietnamese accompanied by original labels and user guides (confirmed by the organization applying for import);

c) Procedures and formalities for issuing import permits:

- If the application for an import permit does not require any amendments or supplements, the Ministry of Health shall issue the import permit. If the import permit is not issued, a written response explaining the reasons must be provided;

- If the application for an import permit is incomplete, the Ministry of Health shall notify the organization applying for import to supplement and amend the application, specifying in detail the required documents and contents to be amended or supplemented;

- Upon receiving a request for amendment or supplementation, the organization applying for import must make the necessary amendments and supplements within 60 days from the date of notification by the Ministry of Health while bearing responsibility for ensuring the consistency and conformity of the amended content with the previously submitted application and sending it back to the Ministry of Health;

If more than 60 days have passed since the Ministry of Health requested amendments or supplements and the organization applying for import has not submitted the amended or supplemented application, or if the application remains non-compliant after three rounds of amendments or supplements, the Ministry of Health will refuse to issue the medical device import permit;

d) The import permit issued in accordance with this clause shall be valid until December 31, 2024;

5. Regulations on the application of the Common Submission Dossier Template (CSDT) for medical devices in accordance with ASEAN regulations: Mandatory application of the CSDT starting from January 1, 2024;

6. For new circulation number applications submitted before January 1, 2024 in accordance with Article 30 of this Decree:

a) New circulation number applications shall include the documents specified in Article 30 of this Decree, wherein the CSDT and the results of its review as specified in point c of Article 30 of this Decree shall be replaced by the following documents:

- Technical documentation summarizing the medical device: Submit a Vietnamese version, along with technical documentation detailing the functions and technical specifications of the medical device issued by the medical device owner, confirmed by the organization applying for the circulation number. For reagents, calibration substances, and in vitro control materials: technical documentation in Vietnamese, including documentation on raw materials, product safety, production processes, and quality control, clinical and preclinical research reports including stability reports;

- User guide for the medical device: Submit a Vietnamese version confirmed by the organization applying for the circulation number, along with the original English version issued by the medical device owner for imported medical devices;

- The label model to be used when circulating medical devices in Vietnam: Submit a copy of the label model confirmed by the organization requesting circulation number issuance. The label must comply with the requirements stipulated by the law on product labels.

b) The acceptance and examination of the registration dossier for medical device circulation as prescribed in Clauses 1, 2, 3, and 4 of Article 30 of this Decree shall be carried out in accordance with the provisions of Article 32 of this Decree.

c) The acceptance and examination of the registration dossier for medical device circulation as prescribed in Clause 5 of Article 30 of this Decree shall be conducted as follows:

- In cases where there is no requirement to amend or supplement the registration dossier, the Minister of Health shall be responsible for organizing the examination and issuing the circulation number within ninety days from the date of receipt of a complete and valid dossier (including confirmation documents for payment of the examination fee for circulation permit issuance in accordance with the regulations of the Ministry of Finance); if the circulation number is not issued, a written response stating the reasons must be provided;

- If the registration dossier for circulation is incomplete, the Ministry of Health must notify the organization requesting circulation number issuance to supplement and amend the registration dossier, specifying which documents need to be supplemented and which contents need to be amended, and resubmit to the Ministry of Health within sixty days from the date of notification by the Ministry of Health;

- Upon receiving a request to supplement and amend the application dossier for circulation number issuance, the organization requesting circulation number issuance must amend and supplement the dossier in accordance with the notified contents and submit it to the Ministry of Health.

If the organization requesting circulation number issuance has amended and supplemented the dossier but does not meet the requirements, the Ministry of Health will notify the organization requesting circulation number issuance to continue completing the dossier in accordance with the provisions of this clause.

After ninety days from the date the Ministry of Health issues a notification requiring amendment and supplementation, if the organization requesting circulation number issuance fails to amend and supplement the dossier or if after three rounds of amendment and supplementation from the date the Ministry of Health first requests amendment and supplementation, the dossier still does not meet the requirements, the procedure for requesting circulation number issuance must be restarted.

7. The provision that "Medical devices may not be bought or sold before price declaration and may not be sold at a higher price than the publicly announced price on the Ministry of Health's electronic portal at the time of purchase and sale" shall not apply to tender packages opened before April 1, 2022.

8. For procurement tender packages for medical devices that have approved the bidding plan before the effective date of this Decree but have not yet posted the announcement or issued the bidding invitation, if adjustments to the declared price contents are necessary, the bidding plan shall be adjusted according to the laws on bidding.

Article 2. Implementation clause

This Decree takes effect from the date of issuance.

This Circular takes effect from December 25, 2025/.

1. The Minister of Health shall be responsible for guiding, organizing, and supervising the implementation of this Decree.

2. The Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees under central cities, and related agencies, organizations, and individuals are responsible for implementing this Decree./.