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Venezuela

Product:
In-Vitro Diagnostic Medical Devices Regulation

Overview

- Target Products: Air Conditioners, Refrigerators

- Scheme: Scheme 5

- Validity: 1 Year


Certification Process

1. Initial Certification

- Step 1: Leverage Manufacturer Test Data

- Step 2: PCN Auditor conducts Factory QMS Audit

- Step 3: Test Report Issuance by product:

  * Refrigerators: GCL HCM or Latam

  * Air Conditioners: Nemko Korea

- Step 4: PCN Panama issues the Certificate


2. Maintenance

- GCL Latam Testing & Report ➔ PCN Panama Certification


 Scheme 5 Cycle (3 Years)

- Year 0 (Initial): Full QMS Audit + Full Type Testing (EE/Safety)

- Year 1 (Surveillance 1): QMS Surveillance + Partial/Full Testing (or Identity Verification)

- Year 2 (Surveillance 2): Design & Component Review + Label Verification

- Year 3 (Recertification): Cycle Restarts (Full Audit + Full Testing)

1. Application form

-Full name, address, email, phone, manufacturer

-Manufacturer’s authorization (if the applicant is not the manufacturer)

-Declaration of relationship with the manufacturer (manufacturer, importer, representative)

2. Apply online

3. No need LR

4. Technical document 

-Test reports of conformity issued by accredited laboratories (RF, EMC, Safety, SAR)

-Photographs of the equipment and labeling

-Certificates of Origin (for importation only)

-User manual in Spanish (sworn translation)

-Technical specification in spanish

-Frequency specification: Technical details of supported frequency bands

-Manufacturer’s Declaration of Conformity

5. Accept FCC, CE, ANATEL, IF

6. Equipment detail 

-Name, brand, model, manufacturer, HS code

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