Effective July 02, 2018, the import of medical devices into Chile will require a new document from the ISP (Instituto Salud Publica-Public Health Institute.) The document, named CDA, can be processed online from the ISP platform, and when approved, will visible to both the importer (CRO/CRA and local laboratories) and the customs office.
The ISP Department suggests that during the trial period of June, 2018, that the largest number of medical devices possible be imported, in order to test the new system and validate the process.
Information Required for CDA
- Codigo DM - ISP (this is the number that ISP will apply for the specific Medical Device
- Product Denomination
- Medical device risk classification
- Name of manufacturer
- What country device was produced
- Origin Country
- Unit of measurement
- Container description
- Is it a sterile product (yes or no)
- Reason for import
- Lot number
- Date of manufacture and expiration date, if applicable
Required Accompanying Documents
- Master Airwaybill (MAWB)
- Commercial Invoice
- Excel document with the details of the medical devices to be imported
If an invoice has products that require the CDA and others that do not, the list to be declared in the CDA that fall under Medical Device must be included, but it is optional to include those that do not need to be declared. It is possible to include several invoices in a single CDA. If the CDA is written in English, it is not necessary to be translated.
ISP Medical Device List
The ISP identifies more than 10.072 different medical devices. A list of these devices will be sent separately to each CRO/Importer and Organization.
Empty Kits will also be considered an Medical Device, and in this case, the Importer can use the name **KITS** to declare and process the CDA, and must include the lot of the entire product. For this reason, it is recommended to ask all the information of the producers of kits in advance, and attach this information in an excel sheet.
As always, contact your local Customer Service Department with any questions or if you need assistance.