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Venezuela

Product:
In-Vitro Diagnostic Medical Devices Regulation
Type:

Venezuela

Qualifications for certificate
Energy Venezuela
<p><span style="color: rgb(255, 0, 0); font-weight: bold;">Overview</span></p><p>- Target Products: Air Conditioners, Refrigerators</p><p>- Scheme: Scheme 5</p><p>- Validity: 1 Year</p><p><br></p><p><span style="color: rgb(255, 0, 0); font-weight: bold;">Certification Process</span></p><p>1. Initial Certification</p><p>- Step 1: Leverage Manufacturer Test Data</p><p>- Step 2: PCN Auditor conducts Factory QMS Audit</p><p>- Step 3: Test Report Issuance by product:</p><p>&nbsp; * Refrigerators: GCL HCM or Latam</p><p>&nbsp; * Air Conditioners: Nemko Korea</p><p>- Step 4: PCN Panama issues the Certificate</p><p><br></p><p>2. Maintenance</p><p>- GCL Latam Testing &amp; Report ➔ PCN Panama Certification</p><p><br></p><p><span style="color: rgb(255, 0, 0); font-weight: bold;">&nbsp;Scheme 5 Cycle (3 Years)</span></p><p>- Year 0 (Initial): Full QMS Audit + Full Type Testing (EE/Safety)</p><p>- Year 1 (Surveillance 1): QMS Surveillance + Partial/Full Testing (or Identity Verification)</p><p>- Year 2 (Surveillance 2): Design &amp; Component Review + Label Verification</p><p>- Year 3 (Recertification): Cycle Restarts (Full Audit + Full Testing)</p>

summary

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)

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