HCM City Customs makes suggestion to remove obstacles for imported medical equipment

The shipment of medical equipment imported via Tan Son Nhat airport

Pursuant to Clause 2, Article 19 of Decree 36/2016/ND-CP dated May 15, 2016 of the Government stipulating that medical equipment is exempt from declaring applied standards and free-sale registration: Medical devices imported into Vietnam for assisting purpose or for display at a fair, exhibition or for product introduction or as a gift.

Pursuant to Clause 1, Article 42 of Decree 36, which is amended and supplemented in Clause 27, Article 1 of Decree 169/2018/ND-CP dated December 31, 2018 stipulating cases, where an import license is required, include eight types:

1- Unregistered medical devices imported to serve scientific research, inspection or training in use or repair of such devices;

2- Unregistered medical devices imported as assistance or humanitarian aid;

3- Unregistered medical devices imported to serve charitable medical examination and treatment;

4- Unregistered medical devices imported for personal treatment of illness, including those specifically manufactured under prescription for treatment of a patient or under a health facility’s request to serve diagnosis work;

5-Registered medical devices containing narcotic substances or precursors; the materials for manufacture of medical devices with narcotic substances or precursors;

6-Medical devices containing narcotic substances or precursors imported for scientific research or inspection;

7-Used medical devices imported to serve research or training (no use on humans or for diagnostic or treatment purposes). Import of medical devices in this case shall be decided by the Prime Minister;

8. Raw materials for manufacture of medical devices with narcotic substances or precursors and imported for scientific research or inspection.

Thus, cases of imports to serve the activities of fairs, exhibitions, display, product introduction or to be used for the purpose of gifts are not subject to licensing in eight cases as above.

Pursuant to the Decision 31/2015/QD-TTg of the Prime Minister dated August 4, 2015 stipulating: Imported and exported goods exceed the baggage allowance, movable property norm, gift norm, sample norms: Organizations and individuals specified in Clauses 1, 2, 3 and 4, Article 2 of this Decision may export or import goods in excess of the tax exemption quota or consider tax exemption as prescribed in Articles 3, 4, 5 and 6 of this Decision provided that the goods satisfy the provisions of law on export and import policies at the time of export or import.

Pursuant to Clause 6, Article 60 of Decree 08/2015/ND-CP dated January 21, 2015, as amended and supplemented in Clause 31 of Decree 59/2018/ND-CP dated April 20, 2018, stipulates: “The luggage of the person entering the country that is on the list of items requiring an import permit or subject to specialized inspection following the provisions of law, has a total value exceeding the limit specified in Clause 5 of this Article. At the time of carrying out import procedures, people on entry to the country must have a license to import goods or a written notification of specialized inspection results. In case the passenger does not have an import license or written notification of specialized inspection results, customs authority will handle in accordance with regulations.”

Pursuant to Point b, Clause 1, Article 68 of Decree 36/2016/ND-CP, as amended and supplemented in Decree 169/2018/ND-CP, and amended and supplemented in Clause 1, Article 1 of Decree 03/2020/ND-CP of the Government stipulates: “b) For medical device of class A, which has received a receipt for declaring applied standards issued by the Department of Health, it is allowed to be imported on demand and no limit in the import quantity without the need for classification and certification of medical equipment issued by the Ministry of Health when carrying out clearance procedures.

For medical devices not on the list of required import license and classified as class B, C, D by a classification organization published by the Ministry of Health on the web portal may continue to import until the end of December 31, 2021 based on the demand, no limit in the import quantity without a written certification of the Ministry of Health as a medical device when carrying out the clearance procedures".

Comparing the above regulations, HCM City Customs Department encountered problems in the implementation process. That is, for imported goods exceeding the baggage allowance, movable property norm, gifts displaying at a fair, exhibition, and product introductions, if goods are on the list of medical equipment according to Circular 14/2018/TT BYT of the Ministry of Health, does it need to apply for an import license from the Ministry of Health according to Article 42 of Decree 36/2016/ND-CP, as amended in Clause 27, Article 1 of Decree No. 169/2016/ND-CP or not.

For goods subject to import license under Clause 1, Article 42 of Decree 36/201 6/ND-CP, as amended in Clause 27, Article 1 of Decree 169/2018/ND-CP, if the conditions mentioned at Point b, Clause 1, Article 68 of Decree 36/2016/ND-CP amending and supplementing in Decree 03/2020/ND-CP are fully satisfied, is it eligible for clearance? Or must it apply for an import license under Clause 1, Article 42 of this Decree.

From the above problems, HCM City Customs Department suggested solutions. For imported goods exceeding the baggage allowance, movable property norm and gifts if they are on the list of medical equipment according to Circular 14/2018/TT-BYT of the Ministry of Health and do not have an import circulation number, they are subject to have import license prescribed in Article 42 of Decree 36/2016/ND-CP, amended in Clause 27, Article 1 of Decree 169/2018/ND-CP.

For imported medical equipment subject to an import license under Clause 1, Article 42 of Decree 36/2016/ND-CP, amended in Clause 27, Article 1 of Decree 169/2008/ND-CP, if the conditions mentioned at Point b, Clause 1, Article 68 of Decree No. 36/2016/ND-CP amended and supplemented in Decree 03/2020/ND-CP are fully satisfied, clearance procedures will be carried out and enterprises are not required to apply for an import license.