Entangled in the implementation of specialized policy, many shipments of medical devices have not been imported

Medical devices are temporarily imported to serve exhibitions. Photo: T.H

HCM City Customs Department said that the unit is encountering problems relating to the import license of chemicals used for hematology analyzers of all kinds (HS code 3822.0090), at the Saigon port area 1 Customs Branch.

Accordingly, on August 1, 2022, the Minister of Health issued Circular No. 05/2022/TT-BYT, in Article 6 of the Circular stipulating the list of medical devices licensed for import to comply with the provisions of Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP.

Through comparison, the list of medical equipment to be granted import licenses specified in Article 6 of Circular 05/2022/TT-BYT includes 46 items that are similar to all items in Appendix I to Circular No. 30/2015/TT -BYT (except for chemicals, diagnostics, cleaning solutions used for medical devices). However, Circular 05/2002/TT-BYT does not contain provisions to annul the effect of Appendix I of Circular No. 30/2015/TT-BYT.

Thus, it encountered problems. In the case that medical devices are classified as A, B, C, D and have a free-sale registration number, if it is in Appendix I of Circular No. 30/2015/TT-BYT or the List of medical equipment to be granted import license as prescribed in Article 6 of Circular 05/2022/TT-BYT, does it require an import permit, or imported on demand, without quantity restriction and not required to get approval by the Ministry of Health in accordance with the provisions of Article 46 of Decree No. 98/2021/ND-CP.

In addition, in the process of carrying out procedures for businesses, HCM City Customs Department encountered difficulties in implementing customs procedures for medical devices temporarily imported to participate in trade fairs and exhibitions.

On August 4, 2022, Link Logistics Service and Trading Co., Ltd. carried out temporary import procedures for medical devices shipments serving fairs and exhibitions at the Tan Son Nhat International Airport Customs Branch and requested this unit carry out customs procedures for the shipment following Official Letter No. 4090/BYT-TB-CT dated August 2, 2022 of the Department of Medical Equipment and Construction.

According to Point 2 of this official dispatch, guiding the application of the provisions at Point d, Clause 2, Article 76 of Decree No. 98/2001/ND-CP and the temporary import and re-export of medical devices, “temporary import, re-exporting medical devices and equipment, traders must comply with the provisions of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government guiding the Law on Foreign Trade Management. Therefore, for medical devices which do not have free-sale registration numbers imported to serve the purpose of fairs, exhibitions, display or product introduction, it is not eligible to apply for an import license under the provisions of Point c, Clause 1 Article 48 of Decree No. 98/2001/ND-CP”.

Pursuant to Clause 2, Article 24 of Decree 98/2021/ND-CP of the Government stipulating cases of exemption from requirements for declaration of applied standards and registration: “Medical devices imported into Vietnam with the purpose of aid or humanitarian medical examination and treatment, or to serve display at trade fair, exhibition or product launch event, or to be used for the purpose of gifts or presents given to health facilities or individual treatment, individual characteristics or serve the demand of special diagnostic of the medical facility”.

Pursuant to Point c, Clause 1, Article 48 of Decree No. 98/2021/ND-CP of the Government providing for import permits: “Unregistered medical devices are imported as assistance or humanitarian aid; gifts or presents given to health facilities; or serve display at trade fairs, exhibitions or product launch events”.

Thus, for medical devices temporarily imported to serve display at trade fairs, exhibitions or product launch events, the provisions of Decree 98/2021/ND-CP are not consistent, while there is no document guiding the implementation of Dispatch 4090/BYT-TB-CT of the Department of Medical Equipment and Constructions - Ministry of Health, so HCM City Customs Department has no basis to consider and settle import procedures for medical devices displayed at trade fairs, exhibitions or product launch events.

Recently, at the border gate, the problems with the value of the circulation number, the license to import medical devices was issued before January 1, 2022 according to point d, clause 2, Article 76 of Decree 98. 2021/ND-CP has arisen.

On August 5, 2022, Le Medtek Joint Stock Company sent an official letter No. 2522 CV/LM requesting HCM City Customs Department handle import procedures following the instructions in Official Letter No. 4090/BYT-TB-CT dated August 2nd, 2022 of the Ministry of Health.

Specifically, in Point 1 of the official dispatch guiding the application of the provisions at Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP: "Medical devices classified as class C or D as published on the Ministry of Health’s Portal does not stipulate to be granted before January 1, 2022. Items that are medical devices in this category, after being imported, are allowed to circulate in Vietnam. HCM City Customs Department said that the above guidance of the Ministry of Health is not consistent with the provisions of Clause 2, Article 76 of Decree No. 98/2021/ND-CP “Regulations on the value of circulation numbers and import permits issued before January 1, 2022”.

In the case that medical devices have been classified as class C or D as published on the Ministry of Health’s Portal before January 1, 2022, not included in Appendix I of Circular No. 30/2015/TT -BYT, but does not mention whether there is a circulation number or not, leading to inconsistent interpretation and inconsistent with provisions at Clause 2, Article 76 stipulates the value of circulation numbers and import permits issued before January 1, 2022. In this case, if the medical devices have not been granted a free-sale registration number or an import permit, is it subject to an extension until the end of December 31, 2022 according to Point d, Clause 2, Article 76 of Decree No. 98/2021 /ND-CP.

In the case that medical devices have been classified C or D after January 1, 2022 and as published on the Ministry of Health’s Portal, not included in Appendix I of Circular No. 30/2015/TT-BYT, but it has not been granted a free-sale registration number or an import permit under Decree 98/2001/ND-CP yet, is it eligible for an extension until the end of December 31, 2022 according to Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP.

In case medical devices have been classified by a classification organization recognized by the Ministry of Health as class C or D from 2017 to 2021, but the publication date is 2022 via the information on the website of the Ministry of Health, so whether the provisions of point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP can be applied or not.

The above problems have been reported by HCM City Customs Department to the General Department of Vietnam Customs to discuss with relevant units for specific guidance.