– View and download: Decision No. 1661/QD-TTg (Approving the plan to reduce and simplify regulations in medical equipment business activities)
– View and download full: Decision No. 1661/QD-TTg: Approving the plan to reduce and simplify regulations related to business activities under the management scope of the Ministry of Health
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DECISION
APPROVING THE PLAN TO REDUCE AND SIMPLIFY REGULATIONS RELATED TO BUSINESS ACTIVITIES UNDER THE MANAGEMENT FUNCTIONS OF THE MINISTRY OF HEALTH
PRIME MINISTER
Pursuant to the Law on Organization of the Government dated June 19, 2015; Law amending and supplementing a number of articles of the Law on Organization of the Government and the Law on Organization of Local Government dated November 22, 2019;
Pursuant to Resolution No. 68/NQ-CP dated May 12, 2020 of the Government promulgating the Program to reduce and simplify regulations related to business activities for the period 2020 - 2025;
At the request of the Minister of Health in Submission No. 1803/TTr-BYT dated September 12, 2021.
DECISION:
Article 1. Approve the plan to reduce and simplify regulations related to business activities under the state management of the Ministry of Health attached to this Decision.
Article 2. The Ministry of Health and relevant ministries and branches within their authority are responsible for implementing the contents and deadlines specified in the Plan to reduce and simplify regulations related to business activities approved by the Prime Minister in Article 1 of this Decision.
During the implementation process, the Ministry of Health shall proactively detect and promptly amend, supplement, replace or abolish, cancel relevant regulations under its authority or make written proposals to the Ministry of Justice and the Government Office for Laws, Decrees of the Government, Decisions of the Prime Minister containing regulations related to business activities that need to be amended, supplemented, replaced or abolished, canceled to implement the Plan to reduce and simplify regulations related to business activities approved by the Prime Minister in Article 1 of this Decision.
Article 3The Government Office shall inspect, urge the implementation and summarize the difficulties of the Ministry of Health and relevant ministries, branches and localities to promptly report to the Prime Minister for resolution in the process of implementing the Plan to reduce and simplify regulations related to business activities approved by the Prime Minister in Article 1 of this Decision.
Article 4This Decision takes effect from the date of signing and promulgation.
Ministers, Heads of ministerial-level agencies, Heads of Government agencies, Chairmen of People's Committees of provinces and centrally run cities and relevant agencies are responsible for implementing this Decision.
Recipient:
– Central Party Secretariat;
– Prime Minister, Deputy Prime Ministers;
– Ministries, ministerial-level agencies, and government agencies;
– People's Committees of provinces and centrally run cities;
– Central Office and Party Committees;
– Office of the General Secretary;
– Office of the President;
– Council of Nationalities and Committees of the National Assembly;
– Office of the National Assembly;
– Supreme People's Court;
– Supreme People's Procuracy;
– National Financial Supervision Commission;
– State audit;
– Social Policy Bank;
– Vietnam Development Bank;
– Central Committee of the Vietnam Fatherland Front;
– Central agencies of organizations;
– Government Office: BTCN, PCNs, Prime Minister's Assistant, General Director of the Government Portal,
Departments, Bureaus, affiliated units, Official Gazette;
– Save: VT, KSTT (2b).
Prime Minister
DEPUTY PRIME MINISTER
Vu Duc Dam
Part V.
BUSINESS LINE 5: MEDICAL EQUIPMENT BUSINESS
I. REGULATIONS ON ADMINISTRATIVE PROCEDURES:
1. Administrative procedures 1: Announcement of eligibility to manufacture medical equipment (administrative procedure code: 1.003006)
a) Content of reduction and simplification:
Abolish the procedure for declaring eligibility to manufacture medical equipment.
Reason: Change the current form of eligibility announcement by controlling conditions through the information technology system. Accordingly, if these establishments want to conduct service business activities, they will only need to update information themselves to prove that they meet the conditions prescribed by law on the National Health Database and based on this information, the state management agency can conduct post-inspection.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government regulating the management of medical equipment (hereinafter referred to as Decree No. 36/2016/ND-CP).
– Implementation roadmap: 2021 – 2022.
2. Administrative procedures 2: Announcement of facilities qualified to classify medical equipment (administrative procedure code: 1.002424)
a) Content of reduction and simplification:
Abolish the procedure for declaring facilities qualified to classify medical equipment.
Reason: Change the current form of eligibility announcement by controlling conditions through the information technology system. Accordingly, if these establishments want to conduct service business activities, they will only need to update information themselves to prove that they meet the conditions prescribed by law on the National Health Database and based on this information, the state management agency can conduct post-inspection.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP.
– Implementation roadmap: 2021 – 2022.
3. Administrative procedures 3: Announcement of qualified facilities to buy and sell medical equipment of types B, C, D (administrative procedure code: 1.003039)
a) Content of reduction and simplification:
Abolish the procedure for declaring facilities qualified to buy and sell medical equipment of types B, C, D.
Reason: Change the current form of eligibility announcement by controlling conditions through the information technology system. Accordingly, if these establishments want to conduct service business activities, they will only need to update information themselves to prove that they meet the conditions prescribed by law on the National Health Database and based on this information, the state management agency can conduct post-inspection.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP.
– Implementation roadmap: 2021 – 2022.
4. Administrative procedures 4: Announcement of eligibility for consulting on medical equipment technology (administrative procedure code: 1.002981)
a) Content of reduction and simplification:
Abolish the procedure for declaring eligibility for consulting on medical equipment technology.
Reason: Change the current form of eligibility announcement by controlling conditions through the information technology system. Accordingly, if these establishments want to conduct service business activities, they will only need to update information themselves to prove that they meet the conditions prescribed by law on the National Health Database and based on this information, the state management agency can conduct post-inspection.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP.
– Implementation roadmap: 2021 – 2022.
5. Administrative procedures 5: Re-issuance of circulation number for medical equipment due to loss or damage (administrative procedure code: 1.002954)
a) Content of reduction and simplification:
Abolish the procedure for re-issuing circulation numbers for medical equipment due to loss or damage.
Reason: To perform level 4 online public services, licensed establishments can reprint by themselves.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP.
– Implementation roadmap: 2021 – 2022.
6. Administrative procedures 6: Re-issuance of Certificate of registration for medical equipment inspection activities (administrative procedure code: 1.002301)
a) Content of reduction and simplification:
Abolish the procedure for re-issuing the Certificate of registration for medical equipment inspection activities.
Reason: To perform level 4 online public services, licensed establishments can reprint by themselves.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP.
– Implementation roadmap: 2021 – 2022.
7. Administrative procedures 7: Re-issuance of medical equipment import license applies in case the import license is still valid but lost or damaged (administrative procedure code: 1.001387)
a) Content of reduction and simplification:
Abolish the procedure for re-issuing medical equipment import licenses applicable in cases where the import license is still valid but is lost or damaged.
Reason: To perform level 4 online public services, licensed establishments can reprint by themselves.
b) Implementation recommendations:
– Amending Decree No. 36/2016/ND-CP.
– Implementation roadmap: 2021 – 2022.
8. Administrative procedures 8: Issuance of certificate of confirmation of medical equipment advertising content (administrative procedure code: 1.002502)
a) Content of reduction and simplification:
Abolish the procedure for granting certificates of advertising content for medical equipment.
Reason: Confirming advertising content is simply to examine the conformity between the content that the enterprise intends to advertise and the documents in the import license application or the circulation registration number, but does not ensure whether the advertising is carried out in compliance with the information in the license application or not. Therefore, it is proposed to remove this procedure and replace it with a regulation that the enterprise with the product must be responsible for the advertising content. In case of violation, the violation will be punished, the operating license will be revoked and the re-registration application for that facility will not be accepted within 24 months from the date of the decision on administrative sanction.
b) Implementation recommendations:
– Amending Decree No. 181/2013/ND-CP and Circular No. 09/2015/TT-BYT.
– Implementation roadmap: 2022 – 2025.
9. Administrative procedures 9: Re-issuance of certificate of medical equipment advertising content in case of loss or damage (administrative procedure code: 1.001063)
a) Content of reduction and simplification:
Abolish the procedure for re-issuing certificates of medical equipment advertising content in case of loss or damage.
Reason: Since the procedure for issuing certificates of advertising content for medical equipment has been abolished, there will be no re-issuance procedure.
b) Implementation recommendations:
– Amending Decree No. 181/2013/ND-CP and Circular No. 09/2015/TT-BYT.
– Implementation roadmap: 2022 – 2025.
10. Administrative procedures 10: Re-issuance of certificate of confirmation of medical equipment advertising content in case of expiration in Clause 2, Article 21 of Circular No. 09/2015/TT-BYT (administrative procedure code: 1.001048)
a) Content of reduction and simplification:
Abolish the procedure for re-issuing the certificate of medical equipment advertising content confirmation in case of expiration in Clause 2, Article 21 of Circular No. 09/2015/TT-BYT.
Reason: Since the procedure for issuing certificates of advertising content for medical equipment has been abolished, there will be no re-issuance procedure.
b) Implementation recommendations:
– Amending Decree No. 181/2013/ND-CP and Circular No. 09/2015/TT-BYT.
– Implementation roadmap: 2022 – 2025.
11. Administrative procedures 11: Re-issuance of certificate of medical equipment advertising content when there is a change in the name or address of the responsible organization or individual and the advertising content does not change (administrative procedure code: 1.001033)
a) Content of reduction and simplification:
Abolish the procedure for re-issuing certificates of medical equipment advertising content when there is a change in the name or address of the responsible organization or individual and the advertising content does not change.
Reason: Since the procedure for issuing certificates of advertising content for medical equipment has been abolished, there will be no re-issuance procedure.
b) Implementation recommendations:
– Amending Decree No. 181/2013/ND-CP and Circular No. 09/2015/TT-BYT.
– Implementation roadmap: 2022 – 2025.
12. Administrative procedures 12: Fast issuance of circulation number for medical equipment (administrative procedure code: 1.002155)
a) Content of reduction and simplification:
– Convert Import License number to Circulation Number
– Amend the regulations on quick circulation number application from 2 FSCs to 1 FSC
– Change the form of circulation registration from regular to express for dossiers that meet the express requirements.
Reason:
– Convert the Import License number to the Circulation Number and acknowledge the quality records for medical equipment that has been granted an import license according to the provisions of Circular No. 30/2015/TT-BYT.
Regarding the requirements for legal documents and technical documents on product quality as prescribed in Circular 30/2015/TT-BYT and Decree No. 36/2016/ND-CP, Decree No. 16/2018/ND-CP on medical equipment management are basically the same, so for 49 groups of medical equipment items that must be granted import licenses according to Circular No. 30/2015/TT-BYT, the licensed items have all been approved by the Ministry of Health's appraisal council and have been used at the unit, and there has been no feedback on the quality, so the Ministry of Health proposes to acknowledge these products and transfer the Import License number to the Circulation Number so that those products can continue to be used for medical examination and treatment and reduce the quantity and time of issuance of circulation numbers, helping businesses proactively plan the import and trading of medical equipment, businesses do not have to buy in advance to store equipment and wait for customs clearance while not having a circulation number, at the same time avoiding interruption in the supply of goods to hospitals with ongoing contracts and also to respond urgently during the current epidemic period.
In addition, it is also clearly stipulated that the registration facility must be responsible for the legality of all registration dossiers according to the provisions of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, the Ministry of Health will conduct post-inspection and revoke the registration number in case the dossier is not in accordance with regulations.
From 2017 to now, 15,803 import licenses have been granted for 49 groups of medical equipment products (specifically, 4,615 licenses were granted in 2017; 5,226 licenses were granted in 2018; 2,671 licenses were granted in 2019; 2,887 licenses were granted in 2020; and 404 licenses were granted in 2021).
The number of applications currently submitted by businesses to request circulation numbers according to the Decree is 10,732.
Thus, when applying the form of converting the Import License number to the Circulation Number, it will reduce the number of applications being submitted as currently 40%. And medical equipment for medical examination, treatment and care, and protection of the people is basically sufficient, there is no shortage of goods due to inability to import. At the same time, the Ministry of Health will also continue to work with the Ministry of Finance to amend Circular No. 278/2016/TT-BTC dated November 14, 2016 on regulations on collection levels, collection, payment, management and use of fees in the health sector, to reduce the amount of fees for businesses to pay when submitting applications with import licenses.
– Amending the regulations on fast-track application from 2 FSCs to 1 FSC: Currently, Article 25 of the Decree stipulates that medical devices that have been circulated in at least 02 countries in the following countries: Japan, Canada, Australia, the US, EU member countries will be included in the fast-track application, and there are 2,859 fast-track applications submitted and 625 applications that are eligible to be transferred to fast-track are waiting for additional information. Applications that meet the requirements for fast-track application will only be considered in terms of legal documents, only 01 expert will cross-read and the processing time will be faster than regular applications.
The Ministry of Health selected the above 5 groups of countries as prestigious countries with high quality products that have been evaluated and recognized worldwide.
Therefore, to reduce the time for processing documents for businesses, it is proposed to reduce the requirement from 2 FSCs to 1 FSC, so the number of fast-issued documents will increase to about 1,500 documents (because the imported goods into Vietnam are 70% from these 5 groups of countries).
– Change the form of circulation registration from regular to fast for dossiers eligible for fast issuance: currently there are 625 dossiers that businesses are eligible for 2 FSCs and are submitting in the regular issuance procedure. At the same time, if the regulation is revised from 2 FSCs to 1 FSC, there will be about 1,500 eligible dossiers, but according to current regulations, if you want to switch to fast issuance, you must resubmit a new dossier.
This solution will support businesses, reduce costs because they have to pay fees for new applications and the management agency will reduce the time it takes to process applications (because the express application only requires 1 expert to read, while the regular application requires 2 to 4 experts depending on the level of medical equipment).
b) Implementation recommendations:
– Amending and supplementing the provisions in Clause 12, Article 1 of Decree No. 169/2018/ND-CP (amending Article 25 of Decree No. 36/2016/ND-CP) regulating the forms of registration for circulation, in which additional cases will be granted a circulation number quickly with the expected content as follows:
Medical equipment has been granted a valid Import License according to Circular No. 30/2015/TT-BYT dated October 12, 2015 regulating the import of medical equipment.
Enterprises create dossiers in accordance with the components prescribed by the Decree and commit that the technical documents in the circulation registration dossier are the same as the import dossier, and at the same time, legal documents such as: Quality Certificate, Free Circulation Certificate, Authorization Letter submitted in the dossier are still valid.
After the application is complete and valid, the Ministry of Health will issue a circulation number within 05 working days. At the same time, it is clearly stipulated that the registration facility must be responsible for the legality of the entire registration dossier according to the provisions of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, the Ministry of Health will conduct post-inspection and revoke the registration number in case the dossier is not in accordance with regulations.
– Implementation roadmap: 2021 – 2022.