Medical equipment imports and exports: Specific regulations will be implemented to meet management needs

DNHN - While defined, the documents that firms must submit/present to Customs when exporting and importing will aid in facilitating products clearance and ensuring management.

It is necessary to specify documents for carrying out customs procedures 

This is one of the contents of the Ministry of Finance (General Department of Customs)'s comments on developing a draft Circular detailing and implementing several articles of Decree No. 98/2021/ND-CP on the management of medical equipment. 

To be specific, Articles 46 and 47 of Decree No. 98/2021/ND-CP establish the principles for managing the export and import of medical equipment, but not yet. Specifically, which documents must be submitted/presented to Customs throughout the procedure's execution? (for example Number of announcements of applicable standards; Number of the circulation registration certificates; Results of equipment classification; medical; Import license). 

As a result, the Ministry of Finance proposes to the Ministry of Health that the draft Circular include detailed instructions on the documentation that firms must submit/present to Customs when exporting or importing.

Simultaneously, the Ministry of Health provides detailed guidance on when to use the classification findings of medical equipment. Is it required by the issuing authority to submit/present the classification result of medical equipment if the enterprise already has a publication number for standards applicable to class A, B medical equipment or a circulation registration certificate number for class C, D medical equipment or an import license issued by the Issuing Authority?

The Ministry of Finance also commented on Clause 3, Article 7 of Decree No. 98/2021/ND-CP stipulating that "customs agencies are responsible for not handling customs clearance procedures" in case medical equipment has expired. being issued a free-sale number using the Classification Results has been withdrawn and the shipment has been cleared but has not yet been sold to the user is not feasible for the Customs office because the shipment has already been cleared. 

Therefore, the Ministry of Health should consider guiding this content in the draft Circular in the direction of assigning the competent agencies that have decided to withdraw the classification results for monitoring and handling.

The Ministry of Finance also commented on Clause 3, Article 7 of Decree No. 98/2021/ND-CP, which states that "customs agencies are responsible for not handling customs clearance procedures" in cases where medical equipment has been issued a free-sale number based on Classification Results and the shipment has been cleared but not yet sold to the user is not feasible for the Customs office because the shipment has already been cleared. 

As a result, the Ministry of Health should consider directing this section of the draft Circular toward assigning the competent agencies that have decided to withdraw the classification findings for monitoring and handling.

As for the regulations on circulation numbers, Clause 1, Article 21 of Decree No. 98/2021/ND-CP, the free-sale registration numbers of medical equipment stipulates: 

a) The number of published standards applicable to class A and B medical equipment; 

b) Number of circulation registration certificates for medical equipment of categories C and D 

Thus, the measure of management of medical equipment according to the free-sale registration number consists of two types: (i) Standard publication number (type A, B) or (ii) number of the circulation registration certificate (type C, D).

Meanwhile, in Appendix II to the draft circular, a list of medical equipment of types B, C, and D has been developed that can be bought and sold as normal goods (for example, personal blood pressure monitors, blood pressure monitors, and blood pressure monitors). measuring blood oxygen saturation (SpO2) using finger clip batteries, children's nasal aspirators, etc.). 

However, it is still unclear which items are of type B and which are of types C and D so that the customs office has a basis for comparison and requires enterprises to present corresponding documents when carrying out import procedures. Therefore, the Ministry of Health needs to develop two separate lists: the list of class A and B medical equipment and the list of class C and D medical equipment as the basis for implementing Clause 1, Article 21 of the Decree. No. 98/2021/ND-CP, avoiding problems during implementation.

Specific instructions on import permits

Regarding import permits, Clause 1, Article 48 of the Decree stipulates that the importation of medical equipment requires an import license, specifically in cases such as medical equipment without a free-sale registration number. imported only to serve scientific research, inspection, testing, testing...; medical equipment without a free-sale registration number imported to meet the urgent needs of disease prevention and control, and to overcome consequences of natural disasters; medical equipment without a free-sale registration number imported to serve the purposes of aid and humanitarian aid; gifts for medical facilities…

These are the contents of regulations on the type of import subject to the application of management measures according to the import license. In addition, Article 48 has no other provisions on the authority to issue and the principles for managing the import of this group of goods according to the List of medical equipment subject to import permits. 

Because the term List of medical equipment subject to an import permit only appears at point d, clause 2, Article 76 of Decree No. 98/2021/ND-CP to guide the content of the transitional clause. Thus, it is not clear how the legal basis for the use of this List will apply management measures under the License. 

Since then, according to the Ministry of Finance, problems will arise when importing medical equipment without a free-sale registration number, the customs authority shall base on the type of importation of the enterprise according to Clause 1, Article 48 or the List medical equipment must be granted an import license or both of these conditions to serve as a basis for determining whether imported goods are subject to licensing or not?

For example, in case medical equipment is imported according to the type specified in Clause 1, Article 48 but not on the List that requires an import permit, or vice versa, the item is on the List but is not imported according to the regulations. in one of the types specified in Clause 1, Article 48, whether the customs authority requires the enterprise to present the import license or not.

Additionally, the Ministry of Finance suggested that the Ministry of Health complete the circular by addressing numerous other issues related to the management of medical equipment, including reagents and diagnostic chemicals used in medical equipment; the list of medical equipment; and medical equipment pricing management and enforcement. 

Huu Han