NOTIFICATION

Addendum

The following communication, dated 26 January 2024, is being circulated at the request of the delegation of Costa Rica.

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Title: RTCR No. 405:2007 "Regulations for the Registration, Classification, Importation and Inspection of Biomedical Equipment and Material"

Description: The purpose of this amendment is to facilitate trade and to make the process for submitting a Certificate of Free Sale (CFS) more flexible so that, in the case of manufactures by third parties or subsidiaries and when the product is not marketed in the country of manufacture, the CFS may be issued by the competent authority of the country where a subsidiary of the company proprietor of the biomedical equipment and material (BEM) or of the parent company is located. The subsidiary must be duly incorporated and not only registered with the competent authority of the country of the proprietor of the product. It also promotes the efficient review of BEM labels, so that there are no further delays in the procedure for assessing post-registration changes. To that end, Transitional Clause III has been extended from 6 months. When a product is subject to recognition of equivalence of the conformity assessment systems of the registration systems, and a CFS is submitted issued by the authority of a country with which no recognition agreement is in place, the notified document clarifies that missing elements must be submitted to complete the file, in order to ensure the efficient review of the label and avoid further delays. This is quite logical, but to avoid misunderstandings, it was decided to provide clarification in the interest of the principle of clear and unambiguous rules.

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