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Colombia

Product:
In-Vitro Diagnostic Medical Devices Regulation
Overview
- Target Products: Air Conditioners, Refrigerators

Certification Process
1. Initial Certification
Step 1: Obtain an ILAC Test Report
Step 2: Issuance of local Colombia OCP Certificate
(Note: PCN is currently reviewing the establishment of an OCP)

2. Maintenance
Step 1: Obtain a Local Lab Test Report OR an ILAC Test Report
Step 2: Issuance of local Colombia OCP Certificate

1. Application form 

-Full name, company address, email, phone

2. Apply Online

3. No need LR

4. Technical document 

-Label or tag (TAC) verifying the link between the terminal equipment’s model, brand, and IMEI.

-Certificate or declaration of conformity from accredited national or international bodies or competent foreign authorities, confirming compliance with applicable technical standards. (Optional).

-User manual

-Circuit/block diagram

-High-resolution device photos (exterior/interior)

5. Accept FCC

6. Equipment detail 

-Device application

-Device type, brand, model, trade name, manufacturer

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