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