“Exploration is the engine that drives innovation. Innovation drives economic growth. So let’s all go exploring.” – Edith Widder
Brazil, Russia, India, and China have over 40% of the world’s population, making this large pool of potential customers a key target for companies eager to enter these potential high-growth markets, which are commonly referred to by the acronym “BRIC.” With close to three billion inhabitants, and their growing middle classes eager to have the same popular electronic products as their US and European global neighbors, these nations have demonstrated healthy economic growth rates for the most part, even with the ongoing global recession. These four countries have been recently ranked in the top seven global economies, based on gross domestic product at purchasing power parity (GDP PPP) per capita, and it has been estimated that the BRIC economies could overtake the block of G7 economies in the next ten to fifteen years. Gaining access to these customers with rising wages has become a priority for increasing global market share.
What these countries share in common are having recently arrived at similar advanced stages of economic development, with a desire to be in the leading economic powers of the twenty-first century, but being held back by old government bureaucracies and weak infrastructures that hinder progress. It has only been in the last fifteen years or so that they have begun to attain accelerated economic growth and rising wages, which have resulted in mass consumerism of high-tech products. Companies importing electronic products can find a maze of confusing and changing requirements, as well as unfamiliar and inefficient methods of conducting business.
To successfully enter the BRIC markets with information technology equipment (ITE) products, it is necessary to understand the legislated compliance requirements, as well as the application of the regulations and test criteria for compliance, including identifying the regulatory bodies, the certification approaches, and the means and effectiveness of enforcement activities. Additionally, information regarding the efficiency and norms of the systems in each country and recommendations for accessing each market are also needed. Let’s get started by taking a look at our first country in the list, Brazil.
There are two main regulatory bodies in Brazil for electronic and electrical product certification, INMETRO and ANATEL. Each has their own specific focus, but they coordinate their activities to ensure compliance in this South American country, where the official language is Portuguese.
INMETRO is the National Institute of Metrology, Standardization and Industrial Quality, which develops and implements the certification systems in Brazil. Tasked with maintaining the national standards, INMETRO is also the national developer of conformity assessment programs as well as the main accrediting authority for certification bodies and laboratories.
ANATEL is Brazil’s national telecommunications agency, responsible for the establishment of authorized bodies for certification and testing activities for EMC compliance. ANATEL is the more dynamic of the two regulatory bodies in Brazil, requiring more activities to keep up with the rapid pace of technological developments.
Established in 1998, ANATEL promotes the development of Brazil’s telecommunication industry by exercising standardization, homologation, and market surveillance for compliance. Legislated regulatory compliance requirements are disseminated through several types of legal documents:
Resolution 242 is the general regulation for the certification of telecommunication products. This resolution established the current certification and homologation schemes, authorizing the creation of the certification bodies designated by ANATEL, as well as authorized test laboratories.
Resolution 323 represents improvements made to the original Resolution 242. Both Resolutions give the legislated regulatory compliance requirements in Brazil, along with the Instrumentos de Gestão and Oficios Circulares issued by ANATEL.
Instrumento de Gestão, or “Management Tools”, are also called IGs. These publications give additional details on processes and providers for Brazil approvals. These are published on ANATEL’s web site.
Oficios Circulares are offical letters from ANATEL, with the purpose of clarifying and giving information on Resolutions and official rules concerning the certification processes. These are used to quickly publish updates when ANATEL deems it urgent.
ANATEL has regulations for the various categories of regulatory compliance, issued as ANATEL Regulations and technical bulletins. Resolution 442 contains Brazil’s EMC compliance regulations, and is based on the international CISPR 22 and CISPR 24 standards, with EMC requirements similar to the CE Mark in the European Union (EU) for radiated emissions and immunity. These test requirements should be followed closely to successfully obtain certification.
Special attention should also be paid to labeling requirements, including warning statements in Portuguese either on the label or in the user instructions. For ANATEL product certification labels, bar codes are assigned, which are known as GS1 or EAN codes. ANATEL uses the database of GS1/EAN Brazil to identify the organization obtaining ANATEL approval, for purposes of market surveillance audits and tracking reported issues.
In Brazil certification and testing must be performed by authorized organizations. The homologation certificate will be issued by ANATEL, and have no expiration date. In addition, the product must be certified by a Designated Certification Body.
The certification process follows this progression:
- Application and product sample submittals
- Required tests and report production
- Issuance of official test reports
- Issuance of product certificates
- Registration of the certificate in the Federal Register
- Periodic inspections to ensure continued compliance
Organismo de Certificacao Designado, or “Designated Certification Body,” is referenced by the acronym “OCD.” These are companies authorized by ANATEL to perform product evaluations, in order to certify the product according to ANATEL rules. To obtain ANATEL product certification, it is necessary to interface with one of the authorized Brazilian OCDs. During certification, testing must be performed by a test lab that has been accredited either by INMETRO, an OCD, or a foreign laboratory member of the International Laboratories Accreditation Cooperation.
Manufacturers and importers are responsible for continued compliance of their products in Brazil. They must comply with all regulations and any special stipulations given in the approved reports and certifications, or they can face legal repercussions. Any changes to the product as approved is in violation and subject to penalties. Resolution 242, Title VI, Article 54, gives the sanctions which can be levied against violators. These may be applied separately or in combination. Article 61 of Resolution 242 gives the limits on fines that can be assessed for non-fulfillment of any ANATEL provision.
There are several “unwritten rules” for successful product certifications in Brazil. These key items concern the local representative, labeling, and language issues. First, ANATEL certification requires that companies placing their products on the market in Brazil have an authorized local representative. For companies that do not, there are agents available. It is highly advised to acquire the services of one experienced with the ANATEL requirements and processes. Second, the ANATEL agency is very strict on product labeling requirements. It is recommended that you ask for a review of your label design if you have any doubts about the label regulations, and also that you use black and white labels, as color labels must pass a very strict review on matching the mandated color scheme. And third, the technical sections of the ANATEL and OCD websites are in Portuguese, without an option for English-language versions. This is an area where your local representative can be extremely helpful in ensuring that the translated requirements are accurate.
In Russia, navigating the compliance agencies, local requirements, and compliance programs can present numerous challenges. This makes understanding the legislation, regulation, certification, and enforcement activities critical for successfully obtaining product certifications.
A new regulatory compliance process was initiated in 2013, called the “Technical Regulations – Customs Union” (TR-CU) program, and it replaced the previous GOST product approval scheme utilized in Russia. As part of the Eurasian Economic Commission (EEC), a trade agreement was established that allows one set of approvals to cover the compliance requirements for selling ITE products not only in Russia, but also in the former Soviet-bloc countries of Armenia, Belarus and Kazakhstan. The intent of the EEC is for more neighboring countries to be added to this Customs Union over time, creating a system of economic cooperation between member states similar to the EU.
To enter Russia, electronic products must be in compliance with Federal Law. These laws are developed and enacted by the three branches of their federal system, the executive, legislative, and judicial branches. However, these laws are introduced as a series of serial laws, making it very important for companies to have an in-country expert. The current laws for regulatory compliance are given in the Russian Federal Law “On Technical Regulating,” which are incorporated into the TR-CU approval program. This legislation provides for the establishment of the agencies which establish the EMC, product safety, and hygienic regulations in Russia.
The new EMC compliance certification program in Russia has introduced its own system of regulations and bureaucracy. All ITE products approved after February 15, 2013 must follow the new TR-CU program and requirements. The new TR Regulation applicable for EMC compliance of ITE products is TR CU № 879, entitled “Electromagnetic compatibility of hardware.” Careful study of the new TR-CU requirements is advised as there are some major differences from the old GOST approval scheme.
The typical approval process for TR-CU certification follows the same progression:
- Application and product sample submittals
- Required tests and report production
- Issuance of official test reports
- Factory audits, if required
- Issuance of product and/or factory certificates
- Registration of the certificate in the Federal Register
- Periodic inspections to ensure continued compliance
A major difference from the old GOST system is that the TR-CU scheme requires a local representative in Russia to hold the certification. This person must be authorized to act as an official company representative by the importing organization, and will be legally liable in the event of any non-compliance. Another difference is that a TR-CU factory inspection is mandatory for product certifications, inspections which must be performed by auditors authorized by TR-CU.
The following documents are required for TR-CU certifications:
- The CB certificate and CB test report
- EMC test report
- User manual and instructions in Russian language
- Label drawing with certification body code
- Factory ISO certificates
- TR-CU authorized factory inspection report
- Ergonomics test report/certification (for displays)
Once the TR-CU certificate is issued, it is valid for one to five years, with the term chosen by the manufacturer. After the initial term, it must be renewed annually for as long as the product is offered for sale in Russia. If the product is modified during the validity period, it must be resubmitted for approval by the agency.
All products imported to Russia must carry the new EAC mark of conformity, shown in Figure 3. The EAC logo is required on the product.
Russia Compliance Enforcement
The manufacturers and importers are responsible for continued compliance while their products are placed on the market in Russia. This means that they must comply will all regulations and any special stipulations given in the approved reports and certification documents. Any changes to the product as approved is considered a non-compliance, unless it has been resubmitted for approval and granted certification.
In Russia, special attention must be given to the laws and regulations in place, as penalties for non-compliance can be very harsh. In addition to civil penalties, such as fines, there are also criminal charges that can be filed in cases of human health and safety, or for defrauding customers. Since these regulations are based on federal laws, enforcement is by federal police. In addition to charges against the local company representatives, company officers can be held liable, and company assets can be seized and forfeited to pay off civil penalties. It is vital to thoroughly understand customs.
Russia also has some “unwritten rules” that must be followed to ensure imported products will successfully pass through customs, which is the top complication for companies. Failure to master the customs process often means cost overruns beyond the cost of the duties and taxes. In addition, the new TR-CU regulations and certification programs mean that close attention must also be paid to the new customs requirements and criteria for the three additional EEU countries. For these reasons, it is highly recommended that companies procure the services of a customs agent experienced with Russian requirements as well as the importation requirements of Armenia, Belarus and Kazakhstan prior to entering the EEU market.
India EMC Compliance
India has made great strides in aligning their compliance standards and processes with those of more established markets. Their regulatory organizations are government departments, seeking to coordinate their activities as they modernize and help promote the development of industry in India. One indication of this effort is the wealth of information freely available online at these agencies, translated in English.
India has a parliamentary form of government, based on the British system. Two ministries have been authorized by Parliament to be responsible for the generation of rules and requirements covering electronic products manufactured and sold in India, the Ministry of Consumer Affairs, Food, and Public Distribution (MCAFPD) and the Ministry of Communications and Information Technology (MCIT).
The MCAFPD oversees the Bureau of Indian Standards (BIS). The Bureau of Indian Standards Act of 1986 gave BIS statutory authority in creating national standards. With the mandate to develop standards, regulatory markings, and certification programs, this agency seeks to create a culture of quality, and encourage consumer participation in creating and implementing these product requirements.
The MCIT is the government ministry over the Department of Electronics and Information Technology (DeitY), which oversees the Department of Telecommunications (DOT). DOT in turn is the department in charge of the Telecommunications Engineering Center (TEC).
TEC is the designated subject-matter expert group that is authorized to prepare and publish the standards and regulations for the EMC aspects of wired telecom equipment, in cooperation with BIS. The EMC regulations for wired telecom equipment can be found in TEC/EMI/TEL-001/01/FEB-09, “Electromagnetic Compatibility Standard for Telecommunication Equipment,” which can be downloaded from the TEC website. In addition, new specific absorption rate (SAR) requirements came into effect in India in 2012, and TEC is the SAR regulations-making body for this country.
The TEC branch under MCIT is the authorized agency for issuing EMC certifications for telecom equipment. The “IR” certification is the most common type of approval, and all certified equipment must be labeled per the TEC requirements.
The submittal package for certification should contain the following:
- TEC Form A application sheet
- EMC report per TEC/EMI/TEL-001/01/FEB-09 criteria
- Product safety report
- Schematics, bill of materials, and user manual
- Local representative authorization letter
- Technical specification/datasheet
- TEC Form B with two samples of the equipment
India performs market surveillance enforcement activities to ensure that products are certified and manufactured as originally approved. Penalties for non-compliance can range from fines to civil and criminal penalties. Non-approved and non-compliant imported products are frequently seized by customs agents, who are diligent in their review of product documentation and labeling. All aspects of EMC enforcement are directed by TEC, performing market surveillance and reviewing renewal applications to ensure compliance.
Difficulties in clearing customs is one of the most common issues encountered in India. Without the proper importation paperwork and certifications, significant delays can keep products from reaching consumers. Understanding this critical process and the specific requirements will definitely pay off. Hiring an experienced customs agent is recommended, who can ensure proper documentation for customs, and expedite customs clearance. A local agent can also provide schedules for customs clearance, as lead times can fluctuate during the year.
China has a culture and a market shrouded in mystery for many companies entering this large and growing consumer market. If you want approvals for electronic products, then you will face some unique obstacles in this country. There are several barriers to imported products, including distance, language, unfamiliar culture and unsophisticated commercial market condition.
The authority of all laws in China lies with the central ruling body, responsible for establishing the authorized government agencies. After entry to the World Trade Organization (WTO), the Chinese government has undertaken a massive effort to revise its laws and regulations in accordance with WTO rules.
The China Certification and Accreditation Administration (CNCA) was established in 2002, with responsibility for developing the legal regulatory compliance requirements for electronic products. The CNCA was given the authority to govern all aspects of the China Compulsory Certification (CCC) program, the certification program for EMC and product safety for these regulated devices. CNCA publishes a catalog for 22 types of products, covering a total of 159 categories. All products in the CCC product catalog, whether manufactured by a foreign or a Chinese company, must comply with the same CNCA regulations for the specific CCC product program to enter the Chinese market.
Standards are published in Mandarin Chinese language, and official English translations are not always readily available. In addition, changes are frequent as technology changes and China attempts to align more with WTO standards. The standards are referred to as “Harmonized Standards,” but it should be noted that there are some major differences from the international code system for harmonized standards used by such international standards bodies as the IEC. The current Chinese EMC Standard is GB 9254:2008, implemented in 2009 and entitled “Test Method and Limits for Radio frequency disturbance from ITE.” This standard includes requirements for testing at the highest frequency above 108 MHz, and the testing of telecom ports.
The China Compulsory Certification (CCC Mark) under the CNCA is the EMC and product safety compliance program. CNCA accredits CCC certification bodies, who are then authorized to issue CCC certificates. Under CNCA, there are three separate certification organizations, as follows: China National Accreditation Board for Certifiers (CNAB), China National Accreditation Board for Laboratories (CNAL), and China National Auditor and Training Accreditation Board (CNAT). CNAB has accredited nine certification bodies, all of which are in China. Each is accredited and authorized to certify particular types of products and issue the CCC Mark.
A CCC certification body is not allowed to perform CCC testing. All CCC testing must be performed at CNAL-accredited test laboratories. CNAL has accredited over 800 testing laboratories in China, each of which is accredited for CCC testing on certain types of products. Because CNCA has not achieved any mutual recognition agreements (MRA) with any other accreditation body, CCC testing must be performed at CNCA-accredited laboratories in China.
The CCC Mark requires the following steps to be taken to accomplish the whole process:
- Application to a CNCA-accredited certification body
- Sample testing at a CNCA-accredited test laboratories
- Factory inspection by certification body engineers
- Verification of remittance of CCC certification fees, including fees for application, testing, and inspections
- Granting of CCC certification by the certification body
- Purchasing the CCC Mark product label (CCC stickers) or applying for permission to print CCC labels
All applications must be made using the standard form or electronically with a Declaration of Conformity to Chinese standards. The application must be in Chinese. Applications must be accompanied by product samples for EMC testing. A CNCA-accredited lab will be assigned by the certification body to perform EMC tests according to Chinese standards.
One key note about manufacturing. If a factory has never been inspected under either the CCIB or CCEE systems, factory inspection is mandatory before a CCC Mark is granted. The certification body assigns a technical engineer and a quality assurance engineer to inspect the facility. Details of factory inspection criteria are defined in the official publication of CCC Implementation Rules for each category of products.
In general, the items included in an application package will include the following:
- TAB NAL application form
- Business license of applicant
- Power of attorney for local representative
- Description of manufacturer and local representative
- Manufacturer/factory quality system documents
- Equipment specifications
- Block diagrams, circuit diagrams, and assembly diagrams
- User manual and installation instructions
- Details of post-sales support program and commitment
- Photos of interior and exterior (minimum of 5 photos)
The CNCA has its own enforcement agency, and criminal findings will be turned over to law-enforcement agencies. Market surveillance and auditing is performed to ensure continued compliance, and customs, retail outlets, and manufacturers in China are all subject to this oversight, and can be required to provide test samples.
The laws and regulations in China must be absolutely followed, as penalties for non-compliance can be very harsh. In addition to monetary penalties, criminal charges can be filed in cases of human health or safety, up to and including the death penalty. The court system is China is very different from most western countries, and the right to appeal is not always allowed. Since these regulations are based on federal laws, enforcement is by federal authorities. In addition to charges against the local company representative in China, company officers can be held liable, and company assets can be seized and forfeited to pay off civil penalties.
Navigating the regulatory landscape can be very difficult, unless you obtain the services of a knowledgeable regulatory consultant in China. Who you hire is critical, because they will be operating as an authorized representative of your company in China, with the power of attorney that is provided for the application process. Spending the time to find a reputable agent with experience in your company’s product categories will be well worth the investment.
Replacement part regulations are another confusing area. Generally, separate certifications are required if a part also falls into a certification category, such as replacement power supplies for ITE. Also, additional help can be obtained by procuring the services of an experienced customs expert is highly recommended. Clearing customs in China can create customer fulfillment and supply management issues, an important area for global firms, and should be included in the planning for any project launch in this country.
Although the regulatory schemes in these countries can seem excessively bureaucratic, over time the processes have become more streamlined, and international standards continue to be the models these countries are following and adopting. Be sure to keep in mind the specific recommendations that have been provided for each country, to help expedite the approvals processes for electronic product certification.
Please note that the content in this article should not be the sole source of information when submitting for certification. The official standards should be obtained for the authorized agencies, and an experienced regulatory agent should be utilized if in-house expertise is not available. Also remember customs facilitators can be a valuable source of information on the importation of products.
Finally, engineering and regulatory compliance affinity groups are an invaluable resource in staying current on the latest changes to the regulatory compliance requirements and processes. The local chapters of the Institute of Electrical and Electronics Engineers (IEEE), such as the IEEE EMC Society and the IEEE Product Safety Engineering Society, provide presentations and opportunities for networking with regulatory compliance engineers on the changing certification requirements. In addition, social media site Linked In has a wealth of different regulatory compliance-related groups that can be joined at no cost, such as the “International Approvals/Certifications” group, where the latest news on BRIC and other countries regulatory criteria is shared with other group members.
Brazil INMETRO website: www.inmetro.gov.br/english
Brazil ANATEL website: www.anatel.gov.br
Eurasian Economic Commission website: http://eurasiancommission.org/en
India DeitY website: www.deity.gov.in
India TEC website: www.tec.gov.in
China CNCA website: www.cnca.gov.cn
IEEE website: www.ieee.org
Linked In: www.linkedin.com
Mark Maynard is a Director at SIEMIC, a global compliance testing and certification services firm with strategic locations in the US and Asia. He is the new President-Elect for the IEEE Product Safety Engineering Society, and also serves on the Telecommunication Certification Body Council. Mark holds two Texas State University degrees, a BS in Mathematics and a BAAS in Marketing and Business, and has over 20 years of experience in international regulatory compliance engineering and product certifications. He can be reached at firstname.lastname@example.org.