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THE MINISTRY OF FINANCE OF VIETNAM
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 59/2023/TT-BTC

Hanoi, August 30, 2023

CIRCULAR

PRESCRIBING FEES IN MEDICAL SECTOR, AND COLLECTION, TRANSFER, MANAGEMENT AND USE THEREOF

Pursuant to the Law on Fees and Charges dated November 25, 2015;

Pursuant to the Law on State Budget dated June 25, 2015;

Pursuant to the Law on Tax Administration dated June 13, 2019;

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Pursuant to the Government's Decree No. 120/2016/ND-CP dated August 23, 2016 elaborating the Law on Fees and Charges;

Pursuant to the Government's Decree No. 126/2020/ND-CP dated October 19, 2020 on elaboration of the Law on Tax Administration; the Government's Decree No. 91/2022/ND-CP dated October 30, 2022 providing amendments to the Decree No. 126/2020/ND-CP ;

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Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on investment and business conditions under the jurisdiction of the Ministry of Health of Vietnam;

Pursuant to the Government’s Decree No. 14/2023/ND-CP dated April 20, 2023 defining functions, tasks, powers and organizational structure of the Ministry of Finance of Vietnam;

At the request of the Director of the Tax Policy Department;

The Minister of Finance of Vietnam promulgates this Circular prescribing fees in medical sector, and the collection, transfer and management thereof.

Article 1. Scope and regulated entities

1. This Circular introduces regulations on fees in medical sector, and the collection, transfer, management and use thereof. Such fees in medical sector include:

a) Fees for processing of applications for licenses/certificates for receipt/import/export of insecticidal and germicidal preparations for household and medical use;

b) Fees for processing of applications for registration, import/export license or declaration of applied standards for medical devices;

c) Fees for appraisal of fulfillment of eligibility requirements for practicing and doing business in medical sector.

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Article 2. Payers

Payers are organizations or individuals that receive processing/appraisal services from regulatory authorities in respect of the matters specified in Clause 1 Article 1 of this Circular.

Article 3. Collectors

Collectors include the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, the Ministry of Public Security of Vietnam or their affiliated units that are tasked with collecting the fees prescribed in Clause 1 Article 1 hereof and Provincial Departments of Health in charge of collecting the fees prescribed in Clause 1 Article 1 hereof.

Article 4. Fees

Fees in medical sector are prescribed in the Fee Schedule enclosed herewith.

Article 5. Declaration and transfer of collected fees

1. Fees shall be paid at the fee rates specified in Article 4 of this Circular according to the forms prescribed in the Circular No. 74/2022/TT-BTC dated December 22, 2022 of the Minister of Finance of Vietnam prescribing forms and time limits for collection, transfer and declaration of fees and charges within the jurisdiction of the Ministry of Finance of Vietnam.

2. Each collector shall transfer total amount of fees collected in the previous month to its dedicated account opened at the State Treasury by the 05th of each month. Collectors shall declare, collect, transfer and make statements of fees in accordance with the provisions of the Circular No. 74/2022/TT-BTC.

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1. The collector that is the Ministry of National Defence of Vietnam, the Ministry of Public Security of Vietnam or their affiliated unit, may retain 80% of total amount of collected fees to cover the expenses prescribed in Article 5 of the Government's Decree No. 120/2016/ND-CP dated August 23, 2016. The remaining amount (20%) shall be transferred to state budget according to chapters and sub-items of the applicable State Budget Index.

2. For collectors that are the Ministry of Health of Vietnam or their affiliated units and Provincial Departments of Health:

a) Each collector must pay total amount of collected fees to state budget. Funding for covering costs of performing tasks and collecting fees shall be derived from state budget and included in the collector’s cost estimate in accordance with policies and limits on state budget expenditures.

b) In case the collector is a regulatory authority that is provided with a pre-determined funding for covering its operating expenses from collected fees in accordance with the provisions of Clause 1 Article 4 of the Government’s Decree No. 120/2016/ND-CP , it may retain 80% of total amount of collected fees for covering the expenses prescribed in Article 5 of the Decree No. 120/2016/ND-CP . The remaining amount (20%) shall be transferred to state budget according to chapters and sub-items of the applicable State Budget Index.

Article 7. Implementation

1. This Circular comes into force from October 16, 2023 and supersedes the Circular No. 278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance of Vietnam and the Circular No. 11/2020/TT-BTC dated February 20, 2020 of the Minister of Finance of Vietnam.

2. Other contents concerning the collection, transfer, management and use of fees, fee receipts, and disclosure of fee collection regimes which are not mentioned in this Circular shall comply with the provisions of the Law on Fees and Charges, the Law on Tax Administration, the Decree No. 120/2016/ND-CP , the Decree No. 126/2020/ND-CP dated October 19, 2020, the Government’s Decree No. 91/2022/ND-CP dated October 30, 2022, the Government’s Decree No. 11/2020/ND-CP dated January 20, 2020, the Government’s Decree No. 123/2020/ND-CP dated October 19, 2020, the Circular No. 78/2021/TT-BTC dated September 17, 2021 of the Minister of Finance, and the Government’s Decree No. 123/2020/ND-CP dated October 19, 2020.

3. If any documents referred to in this Circular are amended, supplemented or superseded, the new ones shall apply.

4. Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Finance of Vietnam for consideration./.

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PP. MINISTER
DEPUTY MINISTER




Cao Anh Tuan

SCHEDULE OF FEES IN MEDICAL SECTOR

(Enclosed with the Circular No. 59/2023/TT-BTC dated August 30, 2023 of the Minister of Finance of Vietnam)

No.

Description

Unit

Fee

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I

Fees for processing of applications for licenses/certificates for receipt/import/export of insecticidal and germicidal preparations for household and medical use

1

Processing of applications for license to test insecticidal and germicidal chemicals/preparations for household and medical use

Application

3.500

2

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a

Applications for new certificates

Application

11.000

b

Applications for change of trade name

Application

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c

Applications for certificate extension

Application

4.000

d

Processing of applications for additional registration in the following cases: change of name or address of manufacturer/ applicant; change of registration certificate holder; re-issuance of registration certificate; changes in manufacturing location/factory; and changes in uses, quality criteria or direction for use

Application

2.500

3

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Application

600

4

Processing of applications for certificates of free sale of insecticidal and germicidal chemicals/preparations for household and medical use

Application

2.000

5

Processing of applications for license to import insecticidal and germicidal preparations for household and medical use

Application

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6

Processing of applications for declaration of eligibility for manufacturing/testing of insecticidal and germicidal chemicals/preparations for household and medical use, or provision of insecticidal and germicidal services

Application

300

II

Fees for processing of applications for registration, import/export license or declaration of applied standards for medical devices

1

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Of class A

Application

1.000

Of class B

Application

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2

Processing of applications for new registration numbers for class-C or class-D medical devices.

Application

6.000

3

Processing of applications for license to import medical devices

Application

2.000

4

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Application

1.000

III

Fees for appraisal of fulfillment of eligibility requirements for practicing and doing business in medical sector

1

Processing of applications, submitted by the following health facilities, for issuance or re-issuance of operating licenses after revocation due to the reasons stated in Clause 1 Article 48 of the Law on Medical Examination and Treatment; or upon change to organization form or split-up, split-off, consolidation or merger; and for issuance of operating licenses upon relocation or upon change to number of departments/patient beds or organizational structure:

Application

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a

Hospitals

10.500

b

Polyclinics, maternity wards; infirmaries defined in the Law on Medical Examination and Treatment; and family medicine facilities (or health facilities operated in the principle of family medicine)

5.700

c

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- Specialized traditional medicine clinics.

- Communal-level health stations, infirmaries and equivalent.

3.100

d

- Specialized clinics listed in Clause 3 Article 11 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 (excluding traditional medicine diagnosis and treatment clinics and specialized traditional medicine clinics stated in Point c Section 1 Part III of the fee schedule enclosed herewith).

- Medical service providers listed in Clause 3 Article 11 of the Government’s Decree No. 155/2018/ND-CP .

- Health facilities of other types.

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2

Processing of applications for certificates of eligibility to perform medical intervention procedures for sex reassignment

Application

10.500

3

Processing of applications for operating licenses in case of loss, damage or revocation prescribed in Point a Clause 1 Article 48 of the Law on Medical Examination and Treatment; re-issuance of operating licenses upon change of health facility’s name or replacement of person in charge of professional aspects of health facility

Application

1.500

4

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Time

a

Health facilities mentioned in Points a, b, d Section 1 Part III of the fee schedule

4.300

b

Health facilities mentioned in Point c Section 1 Part III of the fee schedule

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5

Processing of applications for issuance, re-issuance or modification of medical practice certificates; re-issuance of medical practice certificates after revocation due to the reasons stated in Points c, d, dd, e, g Clause 1 Article 29 of the Law on Medical Examination and Treatment

Application

430

Processing of applications for issuance of medical practice certificates in cases of loss, damage or revocation stated in Points a, b Clause 1 Article 29 of the Law on Medical Examination and Treatment

Application

150

6

Appraisal of contents of program and movie scripts contained in tapes, disks, software and other storage materials, and documents used for medical service advertising

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1.000

7

Processing of applications for certificates of traditional medicine practitioners

Application

2.500

8

Processing of applications for certificates of family remedies/medicines

Application

2.500

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Appraisal of fulfillment of business conditions in medical device sector (including medical device manufacturing, trading, consulting and inspection services)

Application

3.000

10

Processing of applications for certificates of biosafety laboratory (including biosafety level-3 and level-4 laboratories)

Application

9.000

13.758

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