Official Dispatch 4658/BYT-TB-CT 2019 instructions about import procedures

• Official number: 4658/BYT-TB-CT
• Legislation Type: Official Dispatch
• Organization: The Ministry of Health
• Signer: Nguyen Minh Tuan
• Issued Date: 12/08/2019

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 4658/BYT-TB-CT Re. Instructions about import procedures	Hanoi, August 12, 2019

Dear Representative offices of medical devices import and trading businesses (hereinafter referred to as Business(es)),

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- Class-A medical devices which have already obtained the acknowledgement of receipt of declaration of Class-A product quality standards issued by the Department of Health;  

- Medical devices already classified as Class-B, C and D products and not listed in Appendix I to the Circular No. 30/2015/TT-BYT of the Ministry of Health;

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On this issue, Ministry of Health gives the following opinions:

On May 15, 2016 the Prime Minister signed the Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices. 

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- Pursuant to clause 39 of the Decree No. 169/2018/ND-CP on amendments to point b of clause 5 of Article 68 in the Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices: Group-A medical devices with acknowledgement of receipt of documentation on declaration of applied product standards, issued by the Department of Health, may be imported on demand without being subject to any limit and having to enclose the written confirmation of medical equipment given by the Ministry of Health before customs clearance.

Medical devices not in the list of medical equipment that require import permits and already classified as Class-B, C, and D medical equipment by classifying bodies publicly informed by the Ministry of Health on its website may continue to be imported till December 31, 2019 where necessary without being subject to any limit and having to enclose the written confirmation of medical equipment by the Ministry of health before customs clearance”;

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Hence, all recommendations received from Businesses have already been clearly addressed in the Decree No. 169/2018/ND-CP. Therefore, Ministry of Health is not going to give their confirmations on the aforesaid confirmations.

In order to remove difficulties that Businesses have faced, the Ministry of Health has worked with the Ministry of Finance (General Department of Customs, Tax Policy Department, Import and Export Duty Department, etc.) and issued an official correspondence to the General Department of Customs to request removal of difficulties or problems for enterprises related to the Circular No. 83/2014/TT-BTC and the Circular No. 26/2015/TT-BTC of the Ministry of Finance.   

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Ministry of Health (Department of Medical Devices and Projects) is writing this to inform Businesses for their reference and contact with liaison agencies of the Ministry of Finance (General Department of Customs, Tax Policy Department, Import and Export Duty Department, Department of Customs Supervision and Administration, etc.) to seek possible solutions.

Best regards,

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PP. MINISTER
DIRECTOR OF DEPARTMENT OF MEDICAL EQUIPMENT AND PROJECTS




Nguyen Minh Tuan

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