On March 3, 2023, the Government issued Decree 07/2023/ND-CP amending Decree 98/2021/ND-CP on medical equipment management.
Accordingly, the content of medical equipment price listing is regulated as follows:
- Organizations and individuals producing and trading medical equipment shall list prices of medical equipment at locations as prescribed in Article 17 of Decree 177/2013/ND-CP guiding the Price Law or on the Electronic Information Portal of the Ministry of Health.
- In case of listing medical equipment prices on the Ministry of Health's Electronic Information Portal, the following minimum information must be included:
+ Name and type of medical equipment.
+ Manufacturing company and country; firm, owner country.
+ Unit of calculation.
+ Configuration and technical features of medical equipment.
+ Listed price of medical equipment.
This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:
1. Applications and procedures for vaccine marketing authorization issuance, renewal and amendment.
2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.
3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.
Circular 10/2023/TT-BYT, issued May 11, 2023: Amendments to Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health on templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Circular 23/2021/TT-BYT , issued December 09, 2021: Amendments to some legislative documents on medical equipment, pharmacy and population issued by the Minister of Health
1. This Decree provides for pharmacy practice certificate; pharmacy business; export and import of drugs; registration of herbal ingredients, excipients, capsule shells; assessment of overseas drug manufacturers; power, method and procedures for recalling medicinal ingredients; handling of recalled medicinal ingredients; documents and procedures for issuance of certification of drug advertisement and drug price management.
2. This Decree applies to organizations and individuals in Vietnam and overseas whose operation involves pharmacy in Vietnam.
On January 2, 2024, the Ministry of Health issued Decision No. 04/QD-BYT regarding the designation of units for assessment of the Common Technical Dossier on medical devices according to the ASEAN regulations.
The decision includes:
1. Designation of units responsible for assessment of the Common Technical Dossier by the ASEAN regulations:
- For documentation related to the issuance of circulation numbers for medical devices that are not in vitro diagnostic medical devices: Institute of Medical Device and Health Works.
- For documentation related to the issuance of circulation numbers for in vitro diagnostic medical devices: National Testing Institute for Vaccine and Medical Biologicals.
2. Valid date of the Decision: January 2, 2024.
1. This Circular elaborates Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices (hereinafter referred to as “Decree No. 98/2021/ND-CP”).
a) Classification of medical devices under Clause 5 Article 5 of Decree No. 98/2021/ND-CP;
b) Addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities under Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP;
c) List of class B, class C, and class D medical devices purchased and sold as common commodities mentioned under Clause 1 Article 42 of Decree No. 98/2021/ND-CP;
d) List of medical devices to be inspected for safety and technical functions under Clause 10 Article 70 of Decree No. 98/2021/ND-CP;
dd) List of medical devices to be granted import permit under Point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP.
2. Annuls documents on management of medical devices.
This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:
1. Applications and procedures for vaccine marketing authorization issuance, renewal and amendment.
2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.
3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.
Circular 10/2023/TT-BYT, issued May 11, 2023: Amendments to Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health on templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Circular 23/2021/TT-BYT , issued December 09, 2021: Amendments to some legislative documents on medical equipment, pharmacy and population issued by the Minister of Health
1. This Decree provides for pharmacy practice certificate; pharmacy business; export and import of drugs; registration of herbal ingredients, excipients, capsule shells; assessment of overseas drug manufacturers; power, method and procedures for recalling medicinal ingredients; handling of recalled medicinal ingredients; documents and procedures for issuance of certification of drug advertisement and drug price management.
2. This Decree applies to organizations and individuals in Vietnam and overseas whose operation involves pharmacy in Vietnam.
On January 2, 2024, the Ministry of Health issued Decision No. 04/QD-BYT regarding the designation of units for assessment of the Common Technical Dossier on medical devices according to the ASEAN regulations.
The decision includes:
1. Designation of units responsible for assessment of the Common Technical Dossier by the ASEAN regulations:
- For documentation related to the issuance of circulation numbers for medical devices that are not in vitro diagnostic medical devices: Institute of Medical Device and Health Works.
- For documentation related to the issuance of circulation numbers for in vitro diagnostic medical devices: National Testing Institute for Vaccine and Medical Biologicals.
2. Valid date of the Decision: January 2, 2024.
1. This Circular elaborates Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices (hereinafter referred to as “Decree No. 98/2021/ND-CP”).
a) Classification of medical devices under Clause 5 Article 5 of Decree No. 98/2021/ND-CP;
b) Addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities under Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP;
c) List of class B, class C, and class D medical devices purchased and sold as common commodities mentioned under Clause 1 Article 42 of Decree No. 98/2021/ND-CP;
d) List of medical devices to be inspected for safety and technical functions under Clause 10 Article 70 of Decree No. 98/2021/ND-CP;
dd) List of medical devices to be granted import permit under Point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP.
2. Annuls documents on management of medical devices.
The New Drugs and Clinical Trials (Amendment) Rules, 2023. ClinosolIndia
The latest rules for the registry of Clinical Research Organisations (CRO) in India were issued in The New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.
The registration process requires the CRO to submit an application with all the necessary details about the clinical trial or study, including the name and address of the sponsor, the name and qualifications of the principal investigator, details of the investigational drug, and other relevant information.
Once the application is submitted, the Central Licensing Authority will examine it to ensure that all necessary information has been provided and that the CRO has the necessary infrastructure, personnel, and equipment to conduct the study safely and effectively. If the Authority is satisfied with the application, it will grant registration to the CRO, after which it can conduct the clinical trial or study as per the approved protocol.
These rules are a significant step forward in ensuring the safety and ethical conduct of clinical trials and studies in India, and in providing greater accountability and transparency in the research process.
1. This Circular provides for:
a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;
đ) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.
This Circular provides for templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
Circular 03/2020/TT-BYT issued January 22, 2020: Amendments to some Articles of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on quality of pharmaceutical products and pharmaceutical starting materials
- This Circular provides for the activities relating to production, trading, product declaration, labeling and provision of instructions for use of functional foods such as
supplemented foods, health supplements and medical foods, including foods for special dietary uses.
- This Circular does not apply to nutritional formulas for children. Production, trading,
product declaration, labeling and provision of instructions for use of these products shall
comply with corresponding technical regulations and regulations of law on trading and use of nutritional products for children
The Circular 21/2018/TT-BYT elaborates:
- Criteria for determining a traditional drug that is fully exempt from clinical trial, exempt from certain phases of clinical trial or required to undergo phase 4 of clinical trial or all phases of clinical trial and requirements for clinical data about drug safety and efficacy as the basis for issuance of the certificate of traditional drug marketing authorization.
- Applications and procedures for issuance, extension, adjustment and revocation of certificates of traditional drug/herbal material marketing authorization.
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
Đơn xin công nhận các nhà sản xuất nước ngoài lưu hành thuốc tại Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Phân loại việc công nhận các nhà sản xuất nước ngoài lưu hành thuốc tại Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Thông tư 17/2023/TT-BYT: Amend regulations on requirements for declared content of dietary supplements
From November 9, 2023, the declared content for dietary supplements must meet the following requirements:
(1) Declaring nutrient content
(2) Publication of health recommendations
S.R.O.32(I)/2018.— In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, is pleased to make the following rules, namely
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
1. This Circular provides for information on labels, methods for labeling and package inserts of drugs and medicinal ingredients sold on the market; change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need.
2. This Circular does not apply to labels of:
a) Drugs and medicinal ingredients which are used for export but not yet registered in Vietnam;
b) Drugs imported for non-commercial purposes as regulated in Clause 1 Article 75 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”);
c) Drugs imported to meet urgent need of national defense and security, epidemic control or disaster recovery as regulated in Clause 1 Article 67 of the Decree No. 54/2017/ND-CP.
Qyết định 166/QD-BYT: Ban hành: “Tiêu chí, nguyên tắc đánh giá Hồ sơ kỹ thuật chung về thiết bị y tế theo quy định của ASEAN (Common Submission Dossier Template - CSDT) đối với thiết bị y tế không phải là thiết bị y tế in vitro”; Nội dung chi tiết tại Phụ lục I, II, III kèm theo Quyết định này
Nghị định này quy định về hành vi vi phạm hành chính, hình thức xử phạt, mức xử phạt, các biện pháp khắc phục hậu quả, thẩm quyền lập biên bản, thẩm quyền xử phạt vi phạm hành chính trong lĩnh vực văn hóa và quảng cáo.
2. Các hành vi vi phạm hành chính trong lĩnh vực văn hóa và quảng cáo không quy định
tại Nghị định này thì áp dụng theo quy định về xử phạt vi phạm hành chính trong các lĩnh
vực quản lý nhà nước có liên quan.
More Related Content
Similar to Decree 07/2023/ND-CP: AMENDMENTS TO GOVERNMENT’S DECREE NO. 98/2021/ND-CP DATED NOVEMBER 08, 2021 PRESCRIBING MEDICAL DEVICE MANAGEMENT
The New Drugs and Clinical Trials (Amendment) Rules, 2023. ClinosolIndia
The latest rules for the registry of Clinical Research Organisations (CRO) in India were issued in The New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.
The registration process requires the CRO to submit an application with all the necessary details about the clinical trial or study, including the name and address of the sponsor, the name and qualifications of the principal investigator, details of the investigational drug, and other relevant information.
Once the application is submitted, the Central Licensing Authority will examine it to ensure that all necessary information has been provided and that the CRO has the necessary infrastructure, personnel, and equipment to conduct the study safely and effectively. If the Authority is satisfied with the application, it will grant registration to the CRO, after which it can conduct the clinical trial or study as per the approved protocol.
These rules are a significant step forward in ensuring the safety and ethical conduct of clinical trials and studies in India, and in providing greater accountability and transparency in the research process.
1. This Circular provides for:
a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validation of marketing authorization applications (hereinafter referred to as “marketing application”) for drugs/medicinal materials, renewal and revision thereof;
đ) Rules for validation of applications for license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as “Decree No. 155/2018/ND-CP”);
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validation of marketing applications, renewal and revision thereof; Procedures for validation of applications for the license to import unapproved drugs.
This Circular provides for templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
Circular 03/2020/TT-BYT issued January 22, 2020: Amendments to some Articles of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on quality of pharmaceutical products and pharmaceutical starting materials
- This Circular provides for the activities relating to production, trading, product declaration, labeling and provision of instructions for use of functional foods such as
supplemented foods, health supplements and medical foods, including foods for special dietary uses.
- This Circular does not apply to nutritional formulas for children. Production, trading,
product declaration, labeling and provision of instructions for use of these products shall
comply with corresponding technical regulations and regulations of law on trading and use of nutritional products for children
The Circular 21/2018/TT-BYT elaborates:
- Criteria for determining a traditional drug that is fully exempt from clinical trial, exempt from certain phases of clinical trial or required to undergo phase 4 of clinical trial or all phases of clinical trial and requirements for clinical data about drug safety and efficacy as the basis for issuance of the certificate of traditional drug marketing authorization.
- Applications and procedures for issuance, extension, adjustment and revocation of certificates of traditional drug/herbal material marketing authorization.
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
Đơn xin công nhận các nhà sản xuất nước ngoài lưu hành thuốc tại Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Phân loại việc công nhận các nhà sản xuất nước ngoài lưu hành thuốc tại Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Thông tư 17/2023/TT-BYT: Amend regulations on requirements for declared content of dietary supplements
From November 9, 2023, the declared content for dietary supplements must meet the following requirements:
(1) Declaring nutrient content
(2) Publication of health recommendations
S.R.O.32(I)/2018.— In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, is pleased to make the following rules, namely
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
1. This Circular provides for information on labels, methods for labeling and package inserts of drugs and medicinal ingredients sold on the market; change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need.
2. This Circular does not apply to labels of:
a) Drugs and medicinal ingredients which are used for export but not yet registered in Vietnam;
b) Drugs imported for non-commercial purposes as regulated in Clause 1 Article 75 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”);
c) Drugs imported to meet urgent need of national defense and security, epidemic control or disaster recovery as regulated in Clause 1 Article 67 of the Decree No. 54/2017/ND-CP.
Similar to Decree 07/2023/ND-CP: AMENDMENTS TO GOVERNMENT’S DECREE NO. 98/2021/ND-CP DATED NOVEMBER 08, 2021 PRESCRIBING MEDICAL DEVICE MANAGEMENT (20)
Qyết định 166/QD-BYT: Ban hành: “Tiêu chí, nguyên tắc đánh giá Hồ sơ kỹ thuật chung về thiết bị y tế theo quy định của ASEAN (Common Submission Dossier Template - CSDT) đối với thiết bị y tế không phải là thiết bị y tế in vitro”; Nội dung chi tiết tại Phụ lục I, II, III kèm theo Quyết định này
Nghị định này quy định về hành vi vi phạm hành chính, hình thức xử phạt, mức xử phạt, các biện pháp khắc phục hậu quả, thẩm quyền lập biên bản, thẩm quyền xử phạt vi phạm hành chính trong lĩnh vực văn hóa và quảng cáo.
2. Các hành vi vi phạm hành chính trong lĩnh vực văn hóa và quảng cáo không quy định
tại Nghị định này thì áp dụng theo quy định về xử phạt vi phạm hành chính trong các lĩnh
vực quản lý nhà nước có liên quan.
- Thông tư này quy định các hoạt động liên quan đến sản xuất, kinh doanh, công bố sản
phẩm, ghi nhãn và hướng dẫn sử dụng thực phẩm chức năng bao gồm thực phẩm bổ
sung, thực phẩm bảo vệ sức khỏe và thực phẩm dinh dưỡng y học, kể cả thực phẩm dùng
cho chế độ ăn đặc biệt.
- Thông tư này không áp dụng đối với sản phẩm dinh dưỡng công thức dùng cho trẻ
nhỏ. Việc sản xuất, kinh doanh, công bố sản phẩm, ghi nhãn và hướng dẫn sử dụng sản phẩm này được thực hiện theo quy chuẩn kỹ thuật tương ứng và quy định của pháp luật
về kinh doanh và sử dụng các sản phẩm dinh dưỡng dùng cho trẻ nhỏ
Trình bày những cập nhật, sửa đổi về quy định của pháp luật trong ngành dược, bao gồm:
+ Quy định về đăng ký thuốc, ghi nhãn thuốc, thuốc gia công, chuyển giao công tại Việt Nam.
+ Quy định kê đơn thuốc bằng hình thức điện tử
+ Quy định về hoạt động dược lâm sàng
+ Quy định về quản lý chất lượng thuốc
Căn cứ vào công văn số 2098/BYT-TB-CT ngày 12/04/2023 của Bộ Y tế đề nghị các cơ sở đã thực hiện Công bố hồ sơ Trang thiết bị y tế trên Hệ thống dịch vụ công trực tuyến về quản lý thiết bị y tế (https://dmec.moh.gov.vn) tổ chức rà soát các nội dung theo quy định đối với các thủ tục sau:
- thủ tục đủ điều kiện sản xuất trang thiết bị y tế
- thủ tục công bố đủ điều kiện mua bán trang thiết bị y tế thuộc loại B, C, D
- thủ tục công bố tiêu chuẩn áp dụng đối với trang thiết bị y tế thuộc loại A, B:
Xác nhận lại thông tin về tiêu chuẩn áp dụng và đảm bảo rằng chúng đáp ứng đúng yêu cầu.
Thu hồi số công bố nếu phát hiện không tuân thủ đúng tiêu chuẩn áp dụng.
1. Nghị định này quy định chi tiết một số điều của Luật Khám bệnh, chữa bệnh về:
a) Cấp giấy phép hành nghề khám bệnh, chữa bệnh;
b) Cấp giấy phép hoạt động khám bệnh, chữa bệnh;
c) Áp dụng kỹ thuật mới, phương pháp mới và thử nghiệm lâm sàng trong khám bệnh, chữa bệnh;
d) Quản lý thiết bị y tế tại cơ sở khám bệnh, chữa bệnh;
đ) Huy động, điều động cơ sở khám bệnh, chữa bệnh tham gia hoạt động khám bệnh, chữa bệnh trong trường hợp xảy ra thiên tai, thảm họa, dịch bệnh truyền nhiễm thuộc nhóm A và tình trạng khẩn cấp;
e) Điều kiện bảo đảm cho hoạt động khám bệnh, chữa bệnh;
g) Hướng dẫn các quy định về lộ trình thực hiện; quy định chuyển tiếp liên quan đến giấy phép hành nghề và giấy phép hoạt động.
Nghị định này quy định về Chứng chỉ hành nghề dược; kinh doanh
dược; xuất khẩu, nhập khẩu thuốc; đăng ký lưu hành dược liệu, tá dược, vỏ
nang; đánh giá cơ sở sản xuất thuốc tại nước ngoài; thẩm quyền, hình thức,
thủ tục thu hồi nguyên liệu làm thuốc, biện pháp xử lý nguyên liệu làm thuốc
bị thu hồi; hồ sơ, trình tự thủ tục và thẩm quyền cấp giấy xác nhận nội dung
thông tin, quảng cáo thuốc và biện pháp quản lý giá thuốc.
2. Nghị định này áp dụng đối với cơ quan, tổ chức, cá nhân trong nước
và nước ngoài có hoạt động liên quan đến dược tại Việt Nam.
Decree 154/2018/ND-CP issued Hanoi, November 09, 2018: Amending, supplementing and repealing certain articles of the Government on investment and business conditions in sectors under management of ministry of science and technology and certain regulations on specialized inspections
This Decree prescribes conditions for provision of conformity assessment services in Vietnam, including conditions for organizations to assess conformity of products and goods, production or service provision processes and environment with announced applicable standards or relevant technical regulations, and conditions for organizations to accredit conformity assessment organizations.
Nghị định này quy định về điều kiện kinh doanh dịch vụ đánh giá sự phù hợp tại Việt Nam gồm: Tổ chức đánh giá sự phù hợp đối với sản phẩm, hàng hóa, quá trình sản xuất, cung ứng dịch vụ, môi trường phù hợp với tiêu chuẩn công bố áp dụng, quy chuẩn kỹ thuật tương ứng và tổ chức công nhận tổ chức đánh giá sự phù hợp.
Ngày 04/10/2021, Thủ tướng Chính phủ đã phê duyệt Quyết định số 1661/QĐ-TTg, về phương án cắt giảm và đơn giản hóa các quy định liên quan đến hoạt động kinh doanh thuộc phạm vi quản lý của Bộ Y tế. Quyết định này bao gồm tổng cộng 153 quy định về thủ tục hành chính và 14 quy định về điều kiện kinh doanh.
Theo đó, chính sách này thực hiện quan điểm nhằm tạo điều kiện thuận lợi nhất cho doanh nghiệp và người dân tham gia hoạt động kinh doanh. Mục tiêu là giảm thiểu thời gian và chi phí cho doanh nghiệp và người dân trong việc tuân thủ các quy định liên quan đến hoạt động kinh doanh. Đồng thời, chính phủ cũng hướng tới việc cắt giảm và đơn giản hóa các quy định không cần thiết, không hợp lý, không hợp pháp, cái mà thường tạo rào cản và gây khó khăn cho hoạt động kinh doanh của doanh nghiệp và người dân. Chính sách này được xem là một bước quan trọng nhằm nâng cao hiệu lực, hiệu quả và đảm bảo mục tiêu quản lý nhà nước, đồng thời thúc đẩy sự phát triển của doanh nghiệp.
Ngày 30 tháng 12 năm 2023, Bộ Y Tế ban hành Công văn số 8329/BYT-HTTB- kiểm tra, rà soát thủ tục công bố trang thiết bị y tế, gửi Sở Y Tế tỉnh, thành phố trực thuộc trung ương đề nghị Sở Y Tế khẩn trương thực hiện các nội dung sau:
- Thực hiện rà soát lại các hồ sơ công bố trang thiết bị y tế trên Hệ thống https://dmec.moh.gov.vn theo đúng quy định và các văn bản liên quan (lưu ý rà soát kết quả phân loại trang thiết bị y tế bảo đảm theo đúng quy định về phân loại trang thiết bị y tế);
- Kiểm tra về tính hợp pháp, chính xác của các giấy tờ, tài liệu đã nộp trong hồ sơ và bảo đảm các giấy tờ, tài liệu của hồ sơ luôn còn hiệu lực trong suốt quá trình thực hiện, đồng thời chịu trách nhiệm lưu giữ các giấy tờ, tài liệu trong hồ sơ đã nộp theo quy định
Ngày 02 tháng 01 năm 2024, Bộ y tế ban hành quyết định số 04/QĐ-BYT- Về việc chỉ định đơn vị thẩm định hồ sơ kỹ thuật chung về trang thiết bị y tế theo quy định của ASEAN.
- Quyết định gồm các nội dung sau:
1. Chỉ định các đơn vị tiến hành thẩm định hồ sơ kỹ thuật chung về TTBYT theo quy định của ASEAN
+ Đối với hồ sơ đề nghị cấp số lưu hành TTBYT không phải trang thiết bị y tế chẩn đoán in vitro: Viện Trang thiết bị và Công trình y tế
+ Đối với hồ sơ đề nghị cấp số lưu hành TTBYT chẩn đoán in vitro : Viện Kiểm định Quốc gia Vắc xin và Sinh phẩm y tế
2. Hiệu lực thi hành của Quyết định: Ngày 02 tháng 01 năm 2024
Thông tư này hướng dẫn nội dung, cách ghi thành phần dinh dưỡng, giá trị dinh dưỡng và lộ trình thực hiện đối với thực phẩm bao gói sẵn được sản xuất, kinh doanh, nhập khẩu, lưu thông tại Việt Nam.
This Circular provides guidance on contents and presentation of nutrients and their values (hereinafter referred to as "nutrition facts") on food labels, and the roadmap for implementation with regard to prepackaged foods that are manufactured, sold, imported into, circulated in Vietnam.
1. Thông tư này quy định Danh mục chất cấm sử dụng trong sản xuất, kinh doanh thực phẩm bảo vệ sức khỏe.
2. Thông tư này áp dụng đối với tổ chức, cá nhân Việt Nam; tổ chức, cá nhân nước ngoài tại Việt Nam tham gia sản xuất, kinh doanh thực phẩm bảo vệ sức khỏe; tổ chức, cá nhân có hoạt động liên quan đến thực phẩm bảo vệ sức khỏe tại Việt Nam.
1. This Circular prescribes the Nomenclature List of agents prohibited from production and business of health protection food.
2. This Circular shall apply to domestic entities and persons; foreign entities and persons in Vietnam that are involved in production and business of health protection food; entities and persons whose operations relate to health protection food in Vietnam.
Ngày 03/3/2023, Chính phủ ban hành Nghị định 07/2023/NĐ-CP sửa đổi Nghị định 98/2021/NĐ-CP về quản lý trang thiết bị y tế.
Theo đó, nội dung niêm yết giá trang thiết bị y tế được quy định như sau:
- Tổ chức, cá nhân sản xuất, kinh doanh trang thiết bị y tế thực hiện niêm yết giá trang thiết bị y tế tại các địa điểm theo quy định tại Điều 17 Nghị định 177/2013/NĐ-CP hướng dẫn Luật Giá hoặc trên Cổng thông tin điện tử của Bộ Y tế.
- Trường hợp niêm yết giá trang thiết bị y tế trên Cổng thông tin điện tử của Bộ Y tế phải có đầy đủ các thông tin tối thiểu sau:
+ Tên, chủng loại trang thiết bị y tế.
+ Hãng, nước sản xuất; hãng, nước chủ sở hữu.
+ Đơn vị tính.
+ Cấu hình, tính năng kỹ thuật của trang thiết bị y tế.
+ Giá niêm yết của trang thiết bị y tế.
Thông tư 19/2021/TT-BYT ban hành ngày 16 tháng 11 năm 2021: quy định các mẫu văn bản, báo cáo thực hiện Nghị định số 98/2021/NĐ-CP ngày 08 tháng 11 năm 2021 của Chính phủ về quản lý trang thiết bị y tế.
Quyết định 2426/QD-BYT Ban hành kèm theo Mẫu hồ sơ kỹ thuật chung về trang thiết bị y tế theo quy định của ASEAN, áp dụng trong hồ sơ đề nghị cấp số lưu hành cho các trang thiết bị y tế loại B, C, D.
More from MedGate Vietnam| Regulatory Affairs of Pharmaceutical, Medical Devices, Cosmetic (20)
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हम आग्रह करते हैं कि जो भी सत्ता में आए, वह संविधान का पालन करे, उसकी रक्षा करे और उसे बनाए रखे।" प्रस्ताव में कुल तीन प्रमुख हस्तक्षेप और उनके तंत्र भी प्रस्तुत किए गए। पहला हस्तक्षेप स्वतंत्र मीडिया को प्रोत्साहित करके, वास्तविकता पर आधारित काउंटर नैरेटिव का निर्माण करके और सत्तारूढ़ सरकार द्वारा नियोजित मनोवैज्ञानिक हेरफेर की रणनीति का मुकाबला करके लोगों द्वारा निर्धारित कथा को बनाए रखना और उस पर कार्यकरना था।
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‘वोटर्स विल मस्ट प्रीवेल’ (मतदाताओं को जीतना होगा) अभियान द्वारा जारी हेल्पलाइन नंबर, 4 जून को सुबह 7 बजे से दोपहर 12 बजे तक मतगणना प्रक्रिया में कहीं भी किसी भी तरह के उल्लंघन की रिपोर्ट करने के लिए खुला रहेगा।
Decree 07/2023/ND-CP: AMENDMENTS TO GOVERNMENT’S DECREE NO. 98/2021/ND-CP DATED NOVEMBER 08, 2021 PRESCRIBING MEDICAL DEVICE MANAGEMENT
1. THE GOVERNMENT OF
VIETNAM
--------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
-----------
No.: 07/2023/ND-CP Hanoi, March 03, 2023
DECREE
AMENDMENTS TO GOVERNMENT’S DECREE NO. 98/2021/ND-CP DATED
NOVEMBER 08, 2021 PRESCRIBING MEDICAL DEVICE MANAGEMENT
Pursuant to the Law on Government Organization dated June 19, 2015; the Law on Amendments
to the Law on Government Organization and the Law on Local Government Organization dated
November 22, 2019;
At the request of the Minister of Health of Vietnam;
The Government promulgates a Decree providing amendments to the Government’s Decree No.
98/2021/ND-CP dated November 08, 2021 prescribing medical device management.
Article 1. Amendments to Government’s Decree No. 98/2021/ND-CP dated November 08,
2021 prescribing medical device management
1. Clause 2 Article 21 is amended as follows:
“2. Registration number holder is the organization that declares applied standards for medical
devices or is issued with the certificate of registration of medical devices in accordance with the
provisions of this Decree.”.
2. Article 22 is amended as follows:
“Article 22. Conditions for placement of medical devices on the market
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;
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2. - 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.”
3. Point c Clause 3 Article 32 is amended as follows:
“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. Clause 6 Article 37 is amended as follows:
“6. If the Ministry of Health has given a written response indicating its refusal to permit the
placement of the medical device on the market as prescribed in Clause 5 of this Article, the
registration number holder or distributor shall conduct the recall of medical devices placed on the
market, except those sold to health facilities or users.”.
5. Heading of Section 5 Chapter V is amended as follows:
“Section 5. REVOCATION OF REGISTRATION NUMBER AND DISPOSAL OF
MEDICAL DEVICES OF WHICH REGISTRATION NUMBER IS REVOKED”
6. Clause 14 is added to Article 38 as follows:
3. “14. A document included in the application for registration of medical device is found by a
competent authority to be unconformable with regulations of law.”.
7. Clause 6 is added to Article 39 as follows:
“6. Within 05 working days from the receipt of the written conclusion from a competent
authority as prescribed in Clause 14 Article 38 of this Decree, the registration number issuing
authority shall consider issuing a document on revocation of registration number under its
jurisdiction.
Upon receipt of the document on revocation of registration number, relevant competent
authorities shall follow the procedures in Clauses 3 and 4 of this Article.”.
8. Article 39a is added as follows:
“Article 39a. Disposal of medical devices of which registration number is revoked
1. Medical devices which have been sold to health facilities or users shall still be used until they
are liquidated as prescribed by law or they reach their expiry date, except medical devices
containing defects which are harmful to user’s health but cannot be repaired as prescribed in
Clause 4 Article 34 of this Decree.
2. Where a medical device of which registration number is revoked is not yet sold to users or
health facilities, the registration number holder shall suspend the placement of that medical
device on the market and implement measures for recalling it.".
9. Article 44 is amended as follows:
“Article 44. Posting prices of medical devices
1. Manufacturers and traders of medical devices shall post prices of medical devices at the
locations prescribed in Article 17 of the Government’s Decree No. 177/2013/ND-CP dated
November 14, 2013 or on the web portal of the Ministry of Health of Vietnam.
2. The following information must be provided when posting prices of medical devices on the
web portal of the Ministry of Health of Vietnam:
a) Name and category of the medical device;
b) Manufacturer and manufacturing country; product owner and country of product owner;
c) Unit;
d) Configurations, technical functions of the medical device;
dd) Price of medical device.”.
4. 10. Article 45 is amended as follows:
“Article 45. Declaring prices of medical devices
1. Manufacturers and traders of medical devices shall declare prices of their medical devices;
contents and procedures for declaring prices of medical devices shall comply with regulations of
law on pricing.
2. Based on actual situations and upon the occurrence of considerable changes in prices which
affect the supply of medical devices, payment capacity of buyers and the health insurance fund,
the Minister of Health of Vietnam shall promulgate, update and revise the list of medical devices
subject to compulsory price declaration and guidelines thereon.
3. Prices of medical devices shall be declared in the forms specified in the law on pricing or on
the web portal of the Ministry of Health of Vietnam.”.
11. Article 46 is amended as follows:
“Article 46. Rules for management of import and export of medical devices
1. Importers and exporters of medical devices must satisfy eligibility requirements laid down in
the law on import and export and assume responsibility to ensure quality, quantities, categories
and intended purposes of their imported/exported medical devices.
2. Medical devices that have been granted registration numbers in Vietnam may be exported and
imported without limits on quantities and are exempt from approval of the Ministry of Health of
Vietnam.
3. The import license is required for the medical devices specified in Clause 1 Article 48 of this
Decree which are imported for use in Vietnam.
4. The transport of medical devices other than those specified in Clause 2 and Clause 3 of this
Article into Vietnam in other forms shall comply with regulations of the law on foreign trade
management.
5. Issuance of CFS for medical devices shall comply with regulations of the law on foreign trade
management.
6. Import of used medical devices shall comply with regulations of the law on foreign trade
management.”.
12. Article 48 is amended as follows:
a) Point e Clause 1 Article 48 is amended as follows:
5. e) Unregistered medical devices are imported for use in health facilities with ODA funding and
concessional loans or grants other than ODA grants.”.
b) Point o is added to Clause 2 Article 48 as follows:
“o) In the case specified in Point e Clause 1 of this Article, the application for import license
shall include:
- The original copies or certified true copies of the decision to approve the investment guidelines
and the investment decision for an investment project or the decision to approve project
documents for a project on technical assistance, project costs or grants other than ODA grants, in
which the import of medical devices must be indicated;
- The original copy of certified true copy of the contract for supply of medical devices for the
project;
- The power of attorney granted by the product owner to the applicant which must be still valid at
the date of application submission. Either the document bearing consular legalization or the
certified true copy thereof is accepted;
- The certificate of eligibility to provide warranty services granted by the product owner, except
disposable medical devices defined by product owners or cases where there are documents
proving that the medical device is not under warranty. Either the document bearing consular
legalization or the certified true copy thereof is accepted;
- The unexpired CFS (for imported medical devices). Either the document bearing consular
legalization or the certified true copy thereof is accepted. If the CFS is made neither in English
nor in Vietnamese, it shall be translated into Vietnamese. The Vietnamese translation must be
certified as prescribed by law.”.
13. Clause 3 Article 52 is amended as follows:
“3. Post and declare prices of medical devices in accordance with the provisions of this Decree
and the law on pricing.”.
14. Clause 12 is added to Article 66 as follows:
“12. If any document required for completing procedures specified in this Decree must be
treated as confidential, it shall be submitted in person and managed in accordance with
regulations on management of confidential documents.”.
15. Article 70 is amended as follows:
a) Clause 5 Article 70 is amended as follows:
“5. Publish the following information on its web portal:
6. a) Successful bids for procurement of medical devices by state-owned health facilities
nationwide;
b) List of medical devices of which registration number has been revoked;
c) List of organizations/individuals forging applications or committing violations against
regulations on management of medical devices set out in this Decree.”.
b) Clause 7 Article 70 is amended as follows:
“7. Play the leading role and cooperate with regulatory authorities in conducting inspections,
settling complaints/denunciations and taking actions against violations related to medical devices
in accordance with regulations of this Decree and relevant laws.”.
c) Clause 13 and Clause 14 are added to Article 70 as follows:
“13. Publish and revise the list of medical devices subject to compulsory price declaration to
meet management requirements and actual situations.
14. Give guidelines for information on medical devices subject to compulsory price
declaration.”.
16. Clause 5 Article 73 is amended as follows:
“5. Take responsibility to organize and process procedures as prescribed in this Decree; organize
inspections, settle complaints/denunciations and take actions against violations related to medical
devices and their prices in their provinces in accordance with regulations of law.”.
17. Article 74 is amended as follows:
a) Point o Clause 3 Article 74 is amended as follows:
“o) Post and declare prices of medical devices in accordance with the provisions of this Decree
and the law on pricing.”.
b) Clause 5 is added to Article 74 as follows:
“5. When submitting applications for handling of procedures as prescribed in this Decree, the
applying organizations or individuals shall:
a) assume legal responsibility for the accuracy and legitimacy of documents and materials
included in their submitted applications;
b) ensure the consistency and conformity of information on medical device provided in the
initially submitted request or application with that provided in documents additionally submitted
at the request of competent authorities;
7. c) ensure the validity of submitted documents during the handling of procedures;
d) retain documents included in their submitted applications.”.
18. Article 76 is amended as follows:
“Article 76. Transition
1. Applications for issuance of marketing authorization number which have been submitted
according to the provisions of the Government’s Decree No. 36/2016/ND-CP dated May 15,
2016, as amended in the Government’s Decree No. 169/2018/ND-CP and the Government’s
Decree No. 03/2020/ND-CP (hereinafter referred to as “Decree No. 36/2016/ND-CP”) before
January 01, 2022 but have not been yet processed by the effective date of this Decree shall be
processed as follows:
a) With regard to an application for registration of Class-B medical device, the Ministry of
Health of Vietnam shall instruct the applicant to review the submitted application and follow
procedures for declaration of applied standards in accordance with this Decree without paying
additional fee.
b) With regard to an application for registration of Class-C or D medical device, the Ministry of
Health of Vietnam shall issue registration number according to Article 32 of this Decree if it
meets all of the requirements laid down in Clause 3 Article 30 of this Decree;
c) The classification result given by a classification body eligible to classify medical devices
before the effective date of this Decree may be used.
2. Regulations on validity of import license; import of medical devices which are not subject to
import license requirements:
a) An import license for medical devices other than IVD reagents which is issued within the
period from January 01, 2018 to December 31, 2021 shall remain valid until December 31, 2024
inclusively;
b) An import license for medical devices which are IVD reagents which is issued within the
period from January 01, 2018 to December 31, 2021 shall remain valid until December 31, 2024
inclusively and impose no limit on import quantities;
c) Holders of import license prescribed in Point a and b of this Clause shall meet relevant
eligibility requirements laid down in laws and assume responsibility for quality, quantity,
categories and uses of their imported medical devices. The Ministry of Health of Vietnam shall
carry out inspections and consider revoking the import license in case of violations against
regulations on management of medical devices;
d) The import of medical devices which are not subject to import license requirements (except
insecticidal and germicidal chemicals and preparations for medical and household use which are
8. used for disinfection of medical devices only) and have been classified as Class-C or D medical
devices as published on the web portal of the Ministry of Health of Vietnam may continue until
the end of December 31, 2024 without limits on import quantities and requiring the Ministry of
Health of Vietnam’s confirmation as medical devices, regardless of the time of publishing
information on such medical devices on the web portal of the Ministry of Health of Vietnam.
When following import procedures, the importer shall declare the number of document
indicating medical device classification results given by itself or by a qualified classification
body and shall assume responsibility for quality, quantity, categories and uses of imported
medical devices.
Customs authorities shall verify the document indicating medical device classification results
declared by the importer on the web portal of the Ministry of Health of Vietnam.
3. Regulations on validity of registration number, certificate of registration of medical device,
and marketing authorization number:
a) Registration numbers issued according to the Decree No. 36/2016/ND-CP before January 01,
2022 shall remain valid indefinitely;
b) Certificates of registration of domestically manufactured medical devices issued before
January 01, 2022 shall remain valid until the expiry dates thereon;
c) Marketing authorization numbers of medical devices which are IVD reagents issued within the
period from January 01, 2014 to December 31, 2019 shall remain valid until December 31, 2024
inclusively;
d) Marketing authorization number issued to medical devices that are IVD reagents within the
period from January 01, 2020 to December 31, 2021 shall remain valid until the expiry dates on
issued marketing authorization certifications;
dd) Holders of certificate of registration or marketing authorization number prescribed in Points
b, c and d of this Clause shall meet relevant eligibility requirements laid down in laws and
assume responsibility for quality, quantity, categories and uses of their imported medical
devices. The Ministry of Health of Vietnam shall carry out inspections and consider revoking
certificates of registration or marketing authorization numbers in case of violations against
regulations on management of medical devices.
4. Regarding applications for import license for medical devices which have been submitted
before January 01, 2022 but have not been yet processed:
The Ministry of Health of Vietnam shall inform and request applicants to complete their
applications for registration number according to the provisions of the Decree No. 98/2021/ND-
CP and prioritize the processing of such applications. If the applicant wants to obtain an import
license according to the submitted application, the Ministry of Health of Vietnam shall issue the
9. import license according to the sequence and procedures in Point c of this Clause if the submitted
application is adequate and meets the requirements laid down in Point a or b of this Clause.
a) An application for import license for a medical device included in the list of medical devices
subject to import license requirements published by the Minister of Health of Vietnam shall
include:
- The application form for import license;
- The unexpired CFS of the category of medical device to be imported (original copy or certified
true copy);
- The manufacturer’s unexpired certificate of conformity with ISO 13485 quality control
standards (the original or copy bearing the applicant’s certification);
- The unexpired power of attorney given by the product owner to the importer (the original or
certified true copy);
- Technical file describing the category of imported medical device in Vietnamese (bearing the
applicant’s certification);
- Catalogue describing functions and technical specifications of category of imported medical
device;
- Documents on clinical evaluation and instructions for use of the product owner or manufacturer
of medical devices which are invasive devices and instruments in cardiology and cranial nerve.
b) An application for import license for IVD reagents shall include:
- Import order;
- The unexpired CFS (original copy or certified true copy);
- The manufacturer’s unexpired certificate of conformity with ISO 13485 quality control
standards (the original or copy bearing the applicant’s certification);
- Standards and methods for quality inspection of medical device (bearing the applicant’s
certification);
- Label and user manual in Vietnamese accompanied with original label and user manual
(bearing the applicant’s certification).
c) Procedures for granting import license:
10. - If the application for import license does not need to be modified, the Ministry of Health of
Vietnam shall issue the import license. If the application for import license is refused, a written
response indicating reasons for refusal shall be given;
- If the application for import license needs to be modified, the Ministry of Health of Vietnam
shall send a request to the applicant for modification, in which documents and/or contents to be
modified must be indicated;
- Upon receipt of the request for modification, the applicant shall provide the modified
application to the Ministry of Health of Vietnam within 60 days from the date of the request and
shall also assume responsibility for the consistency of contents of the modified application and
those of the previously submitted application.
Over 60 days from the receipt of the request for modification from the Ministry of Health of
Vietnam, if the applicant fails to submit the modified application or the application is still
unsatisfactory after 03 modification times, the Ministry of Health of Vietnam shall refuse to
issue the import license;
d) An import license issued according to the provisions of this Clause shall be valid until
December 31, 2024, inclusively.
5. Regulations on application of ASEAN Common Submission Dossier Template (CSDT):
CSDT is compulsory from January 01, 2024.
6. Applications for issuance of registration number submitted before January 01, 2024 as
prescribed in Article 30 of this Decree:
a) An application for issuance of registration number shall include the documents specified in
Article 30 of this Decree of which CSDT document and report on CSDT document validation in
Point c Clause 5 Article 30 of this Decree shall be replaced with the following documents:
- The synopsis of technical description of the medical device: the copy in Vietnamese
accompanied by technical documents describing functions and specifications of the medical
device issued by the product owner and bearing the applicant’s certification shall be submitted.
For in-vitro reagents, calibrators and control materials: the synopsis of technical description in
Vietnamese must be accompanied by documents stating materials and safety of the product,
manufacturing process, pre-clinical and clinical study reports including stability reports;
- The user manual for medical device: the copy in Vietnamese bearing the applicant’s
certification, accompanied by the original copy in English issued by the product owner in case of
imported medical device;
- Sample of the label for the medical device sold in Vietnam: The sample label bearing the
applicant’s certification is submitted. The sample label must meet requirements laid down in
regulations of law on labeling of goods.
11. b) The receipt and processing of applications for registration of medical devices prescribed in
Clauses 1, 2, 3 and 4 Article 30 of this Decree shall comply with the provisions of Article 32 of
this Decree.
c) An application for registration of a medical device prescribed in Clause 5 Article 30 of this
Decree shall be received and processed as follows:
- If the application does not need to be modified, the Minister of Health of Vietnam shall process
the application and consider issuing the registration number within 90 days from the receipt of
the adequate and valid application (including application fee receipt as prescribed by the
Ministry of Finance). If the application is refused, a written response indicating reasons for
refusal shall be provided;
- If the application needs to be modified, the Ministry of Health of Vietnam shall send a request
for modification, in which such documents and contents requiring modification must be
specified, to the applicant that is required to send the modified application to the Ministry of
Health of Vietnam within 60 days from the receipt of the request;
- The applicant shall comply with the request for modification and send the modified application
to the Ministry of Health.
If the modified application is still unsatisfactory, the Ministry of Health of Vietnam shall
continue sending a request for modification to the applicant to modify the application as
prescribed in this Clause.
If the applicant 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.
7. The application of the following regulation: “Prohibition of trading in medical devices before
their prices are declared or at prices higher than those available on the Ministry of Health’s web
portal at the time of trading” is optional with respect to contract packages for bid opening is
made before April 01, 2022.
8. Regarding contract packages for purchase of medical devices for which the supplier selection
plans have been approved before the effective date of this Decree but bidding documents have
yet to be published or issued, the modification of supplier selection plans in respect of price-
related contents shall comply with regulations of law on bidding if it is deemed necessary.”.
Article 2. Implementation
This Decree comes into force from the date on which it is signed.
Article 3. Responsibility for implementation
12. 1. The Minister of Health of Vietnam shall instruct, organize and inspect the implementation of
this Decree.
2. Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of
Provincial People’s Committees and relevant authorities, organizations and individuals are
responsible for the implementation of this Decree./.
ON BEHALF OF THE GOVERNMENT
PP. PRIME MINISTER
DEPUTY PRIME MINISTER
Tran Hong Ha