enEN
cnCN
esES
krKR

Peru

Product:
In-Vitro Diagnostic Medical Devices Regulation

Overview

- Target Products: Air Conditioners, Refrigerators, Washing Machines

- Scheme: Scheme 5

- Validity: 3 Years

- Samples Required: 1 Unit


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

  * Washing Machines: KTC

- 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, company address, email, phone

-Payment receipt or proof number for the procedure

2. Apply Online

3. Need LR

4. Technical document 

-Laboratory test certificates (FCC, CE, etc.) including all supported bands.

-Manufacturer's declaration of conformity

-Product FCC ID or SAR Report (SAR report is mandatory for cellular devices to certify radiation exposure levels)

-IMEI number (cellular devices only; must be registered and validated).

-Certificate or documentation confirming the device supports cellular broadcast functionality (Cell Broadcast) for systems like SISMATE, mandatory

-Technical manual: Includes brand, model, manufacturer’s name and address, and detailed specifications.

-Datasheet: Summary of technical characteristics and functionalities.

-Clear images of the device, including general views and identification label close-ups

5. Accept FCC, CE

6. Equipment detail 

-Device application

-Brand, model, manufacturer’s name and address

-TAC (Type Allocation Code) number for cellular devices

SUBSCRIBE TO OUR NEWSLETTER