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

Over past few days, Ministry of Health (Department of Medical Devices and Projects) has received a lot of written requests from Businesses for confirmation of medical device imports that should be given upon requests of bordergate customs departments to the followings:

- 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;

- Components and input materials imported for manufacture of medical devices.

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. 

On December 31, 2018 the Prime Minister signed the Decree No. 169/2018/ND-CP on amendments and supplements to the Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices. 

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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”;

- Pursuant to clause 39 of the Decree No. 169/2018/ND-CP on amendments to clause 13 of Article 68 in the Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices: “Raw materials, software, accessories and medical gas are exempt from registration and import licensing requirements under this Decree”.

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.   

For instance, on April 11, 2019 the Ministry of Health invited the Ministry of Finance (General Department of Customs, Tax Policy Department, Import and Export Duty Department, etc.) and representatives of enterprises or foreign entities to join a meeting to discuss and disseminate regulations laid down in the Decree No. 169/2018/ND-CP dated December 31, 2018 on amendments and supplements to the Decree No. 36/2016/ND-CP on management of medical equipment and recommendations for amendments to any inappropriate regulation laid down in the Circular No. 83/2014/TT-BTC and the Circular No. 26/2015/TT-BTC of the Ministry of Finance with respect to the medical device sector.

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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