Ordinance On The Fees For Importers And Distributors Of Medical Devices

Original Language Title: Bekendtgørelse om gebyrer for importører og distributører af medicinsk udstyr

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Publication of fees for importers and distributors of medical devices

In accordance with Article 1 (1) (1), Three, in the law. 1046 of 17. In December 2002 on medical equipment, as amended by law no. 359 of 9. April 2013 :

§ 1. The rules laid down in this notice shall apply when the costs of the Health Board shall be covered by costs :

1) the registration of importers and distributors of medical equipment ; and

2) supervision of importers and distributors of medical equipment and product control (product monitoring).

§ 2. For registration in accordance with section 2 of the notice on importers and distributors of medical equipment, an importer or distributor of medical equipment is paying a registration fee of 1,126 kr. (disposi-cost) to the Board of Health. However, registration fees shall not be paid for the registration of any notification of changes in accordance with Article 2 (2) of the notice. Two and four.

Paragraph 2. The importer or distributor shall also pay an annual fee (annual fee) of 990 kr. to the Board of Health for the Registration, supervision and product control.

Paragraph 3. There is only one registration fee and one annual fee per year per year. the importer and the distributor of medical equipment, whether or not the company concerned imports and / or distributes several different types of medical equipment.

§ 3. No annual fee is paid in the registration year for an importer or distributor of medical devices that first start importing or distributing medical equipment in the last 3 months of the year. For importers and distributors who have initiated the import or distribution of medical equipment in the first 9 months of the year, fully recovered fees shall be paid in the registration year.

Paragraph 2. An importer or distributor who ceaseurs and notifies the Health Care Board of this in the first three months of the year shall not be subject to the payment of the annual fee for this calendar year.

§ 4. The Board of Health may, in exceptional cases, exempt from the payment of the fees referred to in § 2.

§ 5. The Board of Health shall communicate the procedure to the importer or the distributor by way of payment of fees pursuant to this notice.

Paragraph 2. Fees for the services referred to in Section 1 shall be paid to the Board of Health at the latest within one month after the claim.

Entry into force-determination

§ 6. This notice shall enter into force on 1. January 2014.

Paragraph 2. At the same time, notice No 842 of 28. June 2013 on fees for importers and distributors of medical devices.

The Ministry of Health and Prevention, the 16-site. December 2013

Astrid Krag

/ Nina Moss