Draft: DECREE Amending and supplementing Article 68 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP on medical equipment management
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GOVERNMENT
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No: /2019/ND-CP SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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Hanoi, date month year 2019
DECREE
Amending and supplementing Article 68 of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management, as amended and supplemented by Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government amending and supplementing a number of articles of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management
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Pursuant to the Law on Organization of the Government dated June 19, 2015;
Considering the proposal of the Minister of Health;
The Government issued a Decree amending and supplementing a number of regulations related to investment and business conditions in the field of medical equipment.
Article 1. Amend and supplement Clauses 5, 6, 11, Article 68 of Decree No. 36/2016/ND-CP as follows:
1. Clause 5 is amended as follows:
“a) For import licenses for medical equipment of types B, C, D and import licenses for in vitro diagnostic biological products issued in 2018, 2019, 2020, 2021, the issued import licenses shall be valid until December 31, 2021 and the Customs Authority shall not control the import quantity in this case, except for the case specified in Clause 1, Article 42 and Point d of this Clause.
Organizations and individuals trading in medical equipment are responsible for ensuring that the documents specified in Point i, Clause 2, Article 66 of this Decree are always valid during the validity period of the import license. In case of not continuing to maintain the validity of the above documents, organizations and individuals trading in medical equipment must be responsible for notifying the Ministry of Health to revoke the issued import license according to regulations.
b) For medical equipment of type A with a receipt of application for declaration of applicable standards issued by the Department of Health, it can be imported according to demand, without quantity restrictions, without requiring a classification and a document confirming that it is medical equipment from the Ministry of Health when carrying out customs clearance procedures;
Medical equipment that is not on the list requiring an import license and has been classified as medical equipment of type B, C, D by a classification organization published by the Ministry of Health on the electronic information portal may continue to be imported until December 31, 2021 according to demand, without quantity restrictions, without requiring a document confirming that it is medical equipment from the Ministry of Health when carrying out customs clearance procedures.
c) For medical equipment that is an in vitro diagnostic biological product that has been granted a circulation registration certificate in accordance with the provisions of the 2005 Pharmacy Law and documents guiding the implementation of this Law, the circulation number granted is valid until the end of the period stated on the circulation registration certificate. Particularly for circulation registration numbers for in vitro diagnostic biological products that expire after January 1, 2019 and before December 31, 2021, the circulation number granted is valid until December 31, 2021;
Medical equipment that is an in vitro diagnostic biological product that has submitted a registration application for circulation according to the provisions of the 2005 Pharmacy Law before January 1, 2019 shall be resolved according to the provisions of the 2005 Pharmacy Law;
Medical equipment that is an in vitro diagnostic biological product imported and submitted during the period from January 1, 2019 to December 31, 2021 will be granted an import license according to the provisions of the 2005 Pharmacy Law and will be valid until December 31, 2021;
Start receiving applications and issuing registration numbers for domestically produced medical equipment from January 1, 2019. Registration numbers are effective from the date of issue.
d) Chemicals, insecticides, and disinfectants used in the household and medical fields with the sole purpose of disinfecting medical equipment that have been granted a circulation certificate and expire after July 1, 2016 and before December 31, 2020, shall continue to use that circulation certificate until December 31, 2020;
Start receiving applications and issuing registration numbers for chemicals and insecticides and disinfectants used in the household and medical fields with the sole purpose of disinfecting medical equipment from January 1, 2019. Registration numbers are effective from the date of issue.
d) For domestically produced medical equipment that has been granted a certificate of registration for circulation, the circulation number is valid until the end of the period stated on the certificate of registration for circulation. Particularly for certificates of registration for circulation that expire after July 1, 2016 and before December 31, 2020, the certificate of registration for circulation will continue to be used until December 31, 2020.”
2. Clause 6 is amended as follows:
“6. Start receiving dossiers declaring applicable standards for medical equipment of type A from January 1, 2017 and the receipt of dossiers declaring applicable standards will be effective from July 1, 2017; start receiving dossiers registering circulation of medical equipment of types B, C, D from July 1, 2017 and the circulation number of medical equipment will be effective from January 1, 2022, except for the cases specified in Points c and d, Clause 5 of this Article.”
3. Clause 11 is amended as follows:
“11. The ASEAN Common Technical Dossier (CSDT) shall be applied from January 1, 2022. From January 1, 2022, establishments requesting the issuance of a circulation number shall not be required to provide the documents specified in Points g, i, and m, Clause 1, Article 26 of this Decree.”
Article 2. Entry into force
1. This Decree takes effect from the date of signing and promulgation.
2. Clauses 5, 6, 11, Article 68 of Decree No. 36/2016/ND-CP, amended and supplemented by Decree No. 169/2018/ND-CP, cease to be effective from the effective date of this Decree.
Article 3. Responsibility for implementation
Ministers, Heads of ministerial-level agencies, Heads of Government agencies, Chairmen of People's Committees of provinces and centrally run cities are responsible for implementing this Decree./.
Recipient:
– Central Party Secretariat;
– Prime Minister, Deputy Prime Ministers;
– Ministries, ministerial-level agencies, and government agencies;
– People's Councils and 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;
– State audit;
– National Financial Supervision Commission;
– Social Policy Bank;
– Vietnam Development Bank;
– Central Committee of the Vietnam Fatherland Front;
– Central agencies of organizations;
– Government Office: BTCN, PCNs, Assistant to the Prime Minister, General Director of the Government Portal,
Departments, Bureaus, affiliated units, Official Gazette;
– Save: VT, KGVX (2b). PC TM. GOVERNMENT
PRIME MINISTER
Nguyen Xuan Phuc