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What Every Company Should Gather as Part of Their Global Regulatory Compliance Management Program

Most manufacturers of electrical and electronic equipment have some sort of a regulatory compliance program. These may be part of the company’s internal procedures, a subscription to a compliance related database or various bits and pieces of information held by key people within the organization. No matter how complex or simple, it is imperative that management involved in global regulatory compliance issues have the right information needed to make their programs work efficiently.

The following describes just a handful of information that includes tips of what compliance managers may be looking to incorporate as part of their global regulatory compliance management program. Understanding the ever-evolving industry and environmental compliance standards and requirements of many countries and market segments can be a considerable task which is best carried out by dedicated staff with subject matter expertise. Going global can be made simple with the right compliance management tools within the organization.

A. COUNTRY SPECIFIC INFORMATION

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1.1  The various laws and regulations (safety, EMC, radio, telecom, environmental, hygienic, energy efficiency, packaging, markings and labeling, etc.) applicable to equipment.

1.2  The various organizations involved in enforcing mandatory requirements for equipment.

1.3  The various certification bodies involved in certifying equipment.

1.4  The customs regulations applicable to importers to release equipment.

1.5  The country voltage/frequency and tolerances, types of power systems and types of plug/receptacles available. For telecom and networking equipment, the interfaces which are regulated and their specifications. For radio equipment, the available frequency bands, channels, maximum power levels, suitability for indoor or outdoor use and their specifications.

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1.6  The pending laws and regulations, responsible organization and time frame which may have an impact on the importation of equipment.

1.7  For mandatory certifications, does the country accept certificates, test reports or declarations of conformity from other countries? Are there mutual recognition agreements between the countries to facilitate acceptance of data and certifications?

1.8  For mandatory certifications, does the country have a registry (public or private) of certified products? What information is posted on the registry and is this proprietary to the company?

1.9  What documentation is needed to obtain approval of equipment or to make up a technical construction file to declare compliance?

2.0  Are there any restrictions on the import of equipment before obtaining approval? Are there any applicable exceptions (such as for testing, in-country assembly, exhibitions, etc.)?

2.1  What rules, if any, apply to the import of equipment after it has received certification? Are there market surveillance requirements? Are there marking requirements? Is there a need for the importer to get an import permit from the regulator?

2.2  What rules, approval schemes and publications are available to specify the application and approval procedures? What is the validity period of a certificate? Is there a need for a local entity to hold the certificate?

2.3  Which organization(s) should be contacted to begin the certification process?

2.4  What certification charges apply? Is there a standardized form or procedure that must accompany a certification request?

2.5  What information must be filed, such as test reports from accredited labs, bill of materials, electrical wiring diagram, photographs, technical specifications, user manual, licenses of safety critical components, list of EMC suppression components, markings, etc.? In what language must these be supplied?

2.6  Are samples required for in-country testing or for verification purposes? Should these be supplied
as-received or must they be specially prepared or configured as for samples for wireless equipment?

2.7  How are applications processed from submittal to certification? What procedures exist for enforcement of the terms of the certificate (annual or maintenance fees, factory follow-up fees, pre-shipment inspection fees, etc.)? What procedures exist for renewals or extending the certificate validity?

2.8  How long does it normally take for an application to be processed and certificate granted? What could possibly cause delays in certification (national holidays, manpower, unstability in government or regional conflicts)?

2.9  Is there a dispute resolution procedure?

2.10  What standards, testing programs and methodologies
are used?

2.11  Can manufacturers participate in development of the standards? How?

2.12  After equipment is approved, what kind of modifications (hardware or software) can be made to the equipment without seeking authorization for a change from the certification bodies that issued the original certificates.

B. SPECIFIC EQUIPMENT INFO – TELECOMMUNICATIONS EQUIPMENT (EXAMPLE)

1.1  What types of equipment or interfaces are subject to mandatory telecommunication requirements?

1.2  Is certification required for network equipment, such as Ethernet switches? If yes, what is the objective of these requirements (network compatibility, reliability, performance)?

1.3  Is certification required for customer premises equipment that connects to the telephone network? If yes, what is the objective of these requirements (prevent harm to the network, compatibility, reliability, performance)?

1.4  Is certification required for wireless telecommunications equipment, whether or not connected to the telecom network? If yes, what types of wireless equipment require certification and what is the objective of these requirements?

1.5  Is certification required for compliance with electromagnetic compatibility (EMC) standards? If yes, what is the scope of these requirements?

1.6  What are the specifications for the various interfaces and is it allowed in the country?

A good regulatory compliance program should address the above questions and be designed to have an update feature of new, and changes to existing, regulatory, environmental and industry standards and their applicability to the company’s product portfolio. It should monitor engineering changes and their potential effect upon compliance. It should manage/coordinate environmental compliance data collection activities. Last, but not least, it should have a maintenance of region or country specific filings/submissions/approvals procedures. favicon

Peter S. Merguerian is President and CEO of Go Global Compliance Inc. and provides regulatory consulting and global certifications for companies worldwide. He has 29 years of global regulatory compliance experience with an emphasis on safety, EMC, wireless and telecom where he had corporate-wide responsibility in various global test laboratories for Market and Conformity Surveillance, Regulatory and Testing Services, Global Engineering, Accreditation, and Global Certifications. Mr. Merguerian holds a bachelor of science degree in electrical engineering from the Illinois Institute of Technology, Chicago.

He speaks 5 languages and owns and moderates two popular global regulatory groups, one on Linked In
“Global Regulatory Compliance” and the other his blog www.globalcompliance.blogspot.com. Mr. Merguerian can be reached at peter@goglobalcompliance.com.

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