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Chile

Product:
In-Vitro Diagnostic Medical Devices Regulation

Overview

Target Products: Air Conditioners, Refrigerators, Washing Machines


Certification Process

Initial Certification: Tested at an MoU Lab ➔ Local Chile OCP issues the certificate

Renewal: Must be conducted at a Local Lab in Chile

1. Application form 

-Full name, company address, and official email

-Company name and contact phone number

-Conformity certificates, UL, IEC, RoHS, or quality/environmental certifications

2. Apply Online

3. No need LR

4. Technical document 

3. 1 Short-range devices (Certificate of Conformity):

-RF test report (FCC/CE/equivalent compliance)

-Technical datasheet, diagrams

-RF declaration of conformity

-No physical samples required

3.2 Devices with cellular connectivity (Type Approval Certificate)

-RF test report

-Band certifications, SAR report, power/modulation characteristics

-SISMATE or equivalent certification

-Frequency Band Label: Printed on the product packaging, indicating the compatible frequency bands.

-IMEI or unique serial number registration

-Two physical samples (for mandatory testing by authorized body)

3.3 Fixed network equipment (RPTC) (Type Approval Certificate)

-Laboratory report on electrical safety and electromagnetic compatibility

-CD with technical documentation (schematics, firmware).

-Physical samples: 1 prototype.

-Compliance with ITU-T standards

-Compatibility with Chilean dialing and signaling tones

4. Supporting Documents

-User manual (English/Spanish preferred)

-Circuit/block diagram

-High-resolution device photos (exterior/interior)

5. Accept FCC or CE, Local Test ( multiband mobile phones)

6. Equipment detail 

-Equipment description

-Device type: Short-range device or Multiband mobile phone

-Brand, model, manufacturer, and module specifications

-Technical specs: Modulation type, operating frequency, antenna gain, max. radiated power/electric field strength

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