越南更新注册申请评估流程政府费用
📅 2023年10月31日
📂 行业洞察
✍️ Grzan
越南财政部于2023年8月30日发布了第59/2023/TT-BTC号通知，涉及医疗保健领域费用的收取、支付、管理和使用的监管。根据该规定，自 2023 年 10 月 16 日起生效的注册申请评估过程的政府费用如下：
·Class A: 1,000,000 VND
·Class B: 3, 000,000 VND
·Class C and Class D: 6.000.000 VND
此前在2023年6月，财政部还发布了第44/2023/TT-BTC号通知，对支持人民和企业的收费进行了监管，该通知有效期至2023年12月31日。这项规定在卫生部登记费等现有政府费用的基础上提供30%的折扣。因此，自2023年10月16日至2023年12月31日生效，注册申请评估过程的政府费用如下：
·Class A: 700.000 VND (30% discount from 1,000,000 VND)
·Class B: 2.100.000 VND (30% discount from 3,000,000 VND)
·Class C and Class D: 4.200.000 VND (30% discount from 6,000,000 VND)
以下是医疗收费表：
(Enclosed with the Circular No. 59/2023/TT-BTC dated August 30, 2023 of the Minister of Finance of Vietnam)
| No. | Description | Unit | Fee (VND 1.000) |
I | Fees for processing of applications for licenses/certificates for receipt/import/export of insecticidal and germicidalpreparations for household and medical use | ||
1 | Processing of applications for license to test insecticidal andgermicidal chemicals/preparations for household and medical use | Application | 3.500 |
2 | Processing of applications for certificates of registration ofinsecticidal and germicidal chemicals/preparations for household and medical use | ||
| a | Applications for new certificates | Application | 11.000 |
| b | Applications for change of trade name | Application | 5.000 |
| c | Applications for certificate extension | Application | 4.000 |
d | Processing of applications for additional registration in thefollowing 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 | Processing of applications for certificates of advertising contents for insecticidal and germicidal chemicals/preparations forhousehold and medical use | Application | 600 |
| 4 | Processing of applications for certificates of free sale ofinsecticidal and germicidal chemicals/preparations for household and medical use | ||
| 5 | Processing of applications for license to import insecticidal and germicidal preparations for household and medical use | ||
6 | Processing of applications for declaration of eligibility for manufacturing/testing of insecticidal and germicidalchemicals/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 | Processing of applications for declaration of applied standards for medical devices | ||
| Of class A | Application | 1.000 | |
| Of class B | Application | 3.000 | |
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 | Processing of applications for license to export medical devices | 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 healthfacilities, 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 uponchange to number of departments/patient beds or organizational structure: | Application | |
| a | Hospitals | 10.500 | |
b | Polyclinics, maternity wards; infirmaries defined in the Law on Medical Examination and Treatment; and family medicinefacilities (or health facilities operated in the principle of family medicine) | 5.700 | |
c | – Traditional medicine diagnosis and treatment clinics. – Specialized traditional medicine clinics. – Communal-level health stations, infirmaries and equivalent. | 3.100 | |
d | – Specialized clinics listed in Clause 3 Article 11 of theGovernment’s Decree No. 155/2018/ND-CP dated November 12, 2018 (excluding traditional medicine diagnosis and treatmentclinics 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. | 4.300 | |
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’sname orreplacement of person in charge of professional aspects of health facility | Application | 1.500 |
4 | Appraisal of the following health facilities upon change in theirscope of practice or addition to list of available medical procedures: | 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 | 3.100 | |
5 | Processing of applications for issuance, re-issuance ormodification of medical practice certificates; re-issuance ofmedical 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 |
6 | Processing of applications for issuance of medical practicecertificates in cases of loss, damage or revocation stated in Points a, b Clause 1 Article 29 of the Law on Medical Examination andTreatment | Application | 150 |
7 | Appraisal of contents of program and movie scripts contained in tapes, disks, software and other storage materials, and documents used for medical service advertising | 1.000 | |
8 | Processing of applications for certificates of traditional medicine practitioners | 2.500 | |
9 | Processing of applications for certificates of familyremedies/medicines | 2.500 | |
| 10 | Appraisal of fulfillment of business conditions in medical devicesector (including medical device manufacturing, trading, consulting and inspection services) | 3.000 | |
9.000 |
