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Global Market Access (GMA)

This section outlines the strategy for obtaining regulatory approval in regions outside of North America and Europe. The goal is to leverage existing test data and certifications to minimize the cost and time required for global expansion.

The CB Scheme (Safety)

The IECEE CB Scheme is an international system for mutual acceptance of test reports and certificates dealing with the safety of electrical and electronic components, equipment, and products.

Strategy

  • IEC 62368-1 Testing: When conducting safety testing for the Power Base Module (e.g., at a UL or Intertek lab), we will explicitly request an IECEE CB Scheme Test Report and Certificate against IEC 62368-1.
  • National Deviations: We will ensure the test lab includes the national deviations for our target markets (e.g., Australia, Japan, Brazil) in the CB Test Report.
  • Leveraging the CB Report: This single report is recognized by National Certification Bodies (NCBs) in over 50 participating countries. It allows us to apply for local safety marks without having to re-test the hardware in each country.

Leveraging CE/FCC for Radio & EMC

Many countries accept or heavily rely on CE (RED) and FCC test reports as the basis for their national radio and EMC approvals.

Australia and New Zealand (RCM)

  • Requirements: The Regulatory Compliance Mark (RCM) covers electrical safety, EMC, and radio communications.
  • Strategy: Australia and New Zealand generally accept CE test reports (EN standards) for EMC and Radio compliance. A local representative is required to hold the compliance folder and sign the Declaration of Conformity. Minor administrative filings are needed, but additional testing is rarely required if CE testing is comprehensive.

Japan (MIC/TELEC & PSE)

  • Radio (MIC/TELEC): The Ministry of Internal Affairs and Communications (MIC) regulates radio equipment. While Japan has its own specific test methods, CE/FCC test data often forms the baseline. A Registered Certification Body (RCB) must review the data and issue the certificate.
  • Safety (PSE): The Power Base Module falls under the Electrical Appliance and Material Safety Law (DENAN) and requires the Diamond PSE mark (for Specified Electrical Appliances). The CB Test Report (with Japanese national deviations) is crucial for obtaining this mark.

Other Markets

  • Brazil (ANATEL): Requires local testing for radio equipment, but FCC/CE reports can sometimes be used to reduce the scope.
  • China (MIC): Requires local testing for both safety (CCC) and radio (SRRC).
  • South Korea (MIC): Requires local testing for both safety (KC) and radio (KC).

Certification Strategy

  1. Prioritize CB Scheme: Obtaining a CB Test Report for safety is the most critical step for global market access.
  2. Comprehensive CE/FCC Testing: Ensure CE and FCC testing covers all anticipated operating modes and frequencies to maximize the reusability of the test reports in other countries.
  3. Local Representatives: Identify and engage local representatives or compliance partners in target countries early in the process, as many regions require an in-country applicant.
  4. Monitor Regulatory Changes: Regulatory requirements change frequently. We will monitor updates in our target markets to ensure ongoing compliance.