NOTIFICATION
Addendum
The following communication, dated 27 April 2022, is being circulated
at the request of the delegation of Costa Rica.
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Title: RTCR 405:2007 Reglamento para
Registro, Clasificación, Importación, y Control de Equipo y Material Biomédico
(Costa Rican Technical Regulation (RTCR) No. 405:2007 "Regulations for the
Registration, Classification, Importation and Inspection of Biomedical
Equipment and Material") (19 pages, in Spanish)
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Reason
for Addendum:
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Comment period changed - date:
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Notified measure adopted - date:
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Notified measure published - date:
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Notified measure enters into force - date:
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[X]
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Text of final measure available from[1]:
http://reglatec.go.cr/reglatec/principal.jsp
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Notified measure withdrawn or revoked - date:
Relevant symbol if measure re-notified:
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Content or scope of notified measure changed and
text available from1:
New deadline for comments (if applicable):
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Interpretive guidance issued and text available
from1:
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[X]
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Other:
Comprehensive review of RTCR No. 405:2007
"Regulations for the Registration, Classification, Importation and
Inspection of Biomedical Equipment and Material"
Description: In accordance with good regulatory
practices, RTCR No. 405:2007 "Regulations for the Registration,
Classification, Importation and Inspection of Biomedical Equipment and
Material" has been reviewed and a decision made to publish a new
technical regulation.
TITLE: RTCR
505: 2022 Equipo y Material Biomedico. Clasificación, Registro, Importación,
Etiquetado, Publicidad, Vigilancia y Control (RTCR No. 505:2022
"Biomedical Equipment and Material. Classification, Registration,
Importation, Labelling, Advertising, Monitoring and Inspection") (56
pages, in Spanish)
AGENCY: Ministerio
de Salud (Ministry of Health)
MEASURE: Technical regulation
https://members.wto.org/crnattachments/2022/TBT/CRI/22_3088_00_s.pdf
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Description: SUMMARY: The purpose
of this technical regulation is to establish the requirements and processes
necessary for the classification, registration, importation and inspection of
biomedical equipment and material intended for human use. It applies to
biomedical equipment and material and their accessories, as well as to mobile
device software and applications (apps) for medical use, that are produced,
imported or marketed in Costa Rican territory.
DATES: The final date for comments is 30 days from the date of
notification.
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[1] This information can be provided by including a website address, a
PDF attachment, or other information on where the text of the final
measure/change to the measure/interpretative guidance can be obtained.