News Alerts

New system of processing Customs Destination Certificates for medical devices without a sanitary registration

June 28, 2018

As of July 2, a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1 that do not have a sanitary registration to be imported into Chile.

The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164”.

Importers of medical devices who are currently registered in the GICONA 2.0 platform may access the CDA-request process by entering the module “Foreign Trade/Imports” (Comercio Exterior/Importación), and selecting the option “Medical Devices without Sanitary Registration” (Dispositivos Médicos sin Registro Obligatorio).

Importers that are not current users of the system will be required to register in the GICONA 2.0 system. This entails identifying as a company or as a natural person, registering a warehouse where the imported medical devices will be stored, and obtaining a password2.

Pursuant to Circular 225 of April 6, 2018, issued by the National Customs Service (SNA, id)3, medical devices without a sanitary registration are associated with specific customs codes, which are – in turn – linked to internal ISP codes (currently codes DM-00001 to DM-10072), which are grouped as follows4:

Grouped products (customs code)
30.06 Pharmaceutical goods
34.07 Modelling pastes, waxes or compounds for dental impression; plaster-based preparations for odontology
33.06 Preparations for oral and dental hygiene, including denture fixative pastes and powders; dental floss
38.22 Diagnostic or laboratory reagents; certified reference materials
40.14 Hygienic or pharmaceutical articles (including bottle nipples), of vulcanized rubber other than hard rubber
87.13 Wheelchairs and other vehicles for disabled persons, whether or not motorized or otherwise mechanically propelled
87.14 Spare parts and accessories for vehicles classified in 87.11 to 87.13
90.01 Optical fibers; sheets and plates of polarizing material; lenses (including contact lenses), optical elements
90.11 Optical microscopes, including for photomicrograph, cinephotomicrograph, or microprojection
90.18 Medicine, surgery, dental or veterinary instruments and devices, including electromedical equipment
90.19 Apparatuses for massages, psychological aptitude-testing, ozone therapy, oxygen therapy or aerosol therapy, for respiratory therapy and reanimation
90.21 Orthopedics items and devices for fractures, binders, medical-surgical bandages, splints; prostheses; earphones
90.22 X-ray apparatuses using alpha, beta or gamma radiation, control consoles, furniture for examination or treatment
94.02 Furniture for medicine, surgery, odontology or veterinary (for example: operating tables)
96.19 Sanitary napkins and tampons, diapers for babies and similar articles, of any material

To submit an online request for a CDA, the importer must upload the invoice, waybill and Quality Certification corresponding to the medical device. In addition, the importation of sterile medical devices will also require the importer to indicate the manufacture and expiration date of the imported batch.

Once a CDA is obtained, it must be submitted to the SNA along with an importation declaration and all other customs documentation required for an importation to be authorized.

Finally, please note that the importation process for medical devices that do have a sanitary registration and that require a Use and Disposal Authorization (AUD) has not been modified and, therefore, will continue to be carried out through the same mechanisms and government services.


1 Further information about this new procedure available here.
2 For further information, see guidelines available here.
3 Available here.
4 Information available at here.

If you have any questions regarding the matters discussed in this news alert, please contact the following attorneys or call your regular Carey contact.

 

Ignacio Gillmore
Partner
+56 2 2928 2612
igillmore@carey.cl

Patricio Laporta
Associate
+56 2 2928 2208
plaporta@carey.cl

Javiera Péndola
Patent and Regulatory Affairs Specialist
+56 2 2928 2766
jpendola@carey.cl

 


This news alert is provided by Carey y Cía. Ltda. for educational and informational purposes only and is not intended and should not be construed as legal advice.

 

Carey y Cía. Ltda.
Isidora Goyenechea 2800, 43rd Floor
Las Condes, Santiago, Chile.
www.carey.cl


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