Worldwide Type Approval, Homologation and Certification Services

Europe

In 1999 the EU liberalized the internal market for radio equipment by implementing the Radio and Telecommunication Terminal Equipment (R&TTE) Directive. To further improve the internal market for goods and strengthen the conditions for placing a wide range of products on the market, the European Union adopted the New Legislation Framework in 2008. With this new framework the EU boosts the quality of conformity assessment and improves the market surveillance. Under this new legislation framework the EU also implements the Electromagnetic Compatibility – Directive 2014/30/EU, the Low Voltage – Directive 2014/35/EU and the Radio equipment – Directive 2014/53/EU also known as RED.

We start with the definition of radio equipment as defined in the Radio equipment directive (RED) Article 2.1(1) as an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radio determination. We want to point out that with this definition radio receivers are explicitly covered by the RED.

To further specify the scope we want to mention that radio equipment installed in vehicles such as cars, caravans, trains, etc has to comply with the RED, so there are some exemptions not discussed here, and RFID tags are also covered.

Responsible Party

The union harmonisation legislation defines four different responsible parties as there are the manufacturer, the authorised representative, the importer and the distributor and defines them as ‘economic operators’. Under those economic operators the main responsibility is put on the manufacturer and some of his responsibilities are following below.

The manufacturer has to carry out the conformity assessment procedure and has to ensure that the equipment can operate in at least one member state of the European union. He is responsible for the compilation of the technical documentation and the issuance of a Declaration of Conformity (DoC) as well as the correct labelling of the product. There may also be the need for carrying out sample testing of the radio equipment made available on the market.

By a written mandate, the manufacturer may appoint an authorised representative to carry out some of his responsibilities on his behalf. This mandate shall at least include the obligation to keep the Declaration of Conformity (DoC) and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the radio equipment has been placed on the market. All of the other duties mentioned above may be transferred as well.

The importer of the radio equipment shall ensure that he is only placing compliant equipment on the market and as such that the manufacturer has followed correctly his obligations resulting form the Radio Equipment Directive (RED).

And finally the distributor shall act in due care of the Radio Equipment Directive (RED) when making radio equipment available on the market which includes but is not limited to ensuring that the product is bearing the correct labelling and accompanied by complete instructions and safety information. He shall ensure that the manufacturer has followed his obligations in correct manner. Essential requirements

In accordance with the Radio Equipment Directive (RED) any radio equipment shall be constructed in a manner as to ensure the protection of health and safety of persons and domestic animals, safeguard the level of electromagnetic compatibility as set out in the EMC directive and finally ensure the effective use of radio spectrum in order to avoid harmful interference.

Labelling

The Radio Equipment Directive (RED) obliges the manufacturer to affix the CE marking to the equipment when placing a product on the market. This marking shall have a minimum height of 5 mm and shall also be affixed visibly and legibly to the packaging. If the nature of the radio equipment does not allow a marking of at least 5 mm, the manufacturer may affix a CE marking that is smaller than 5 mm to the product as long as it remains visible and legible. If it is not possible to affix a CE marking on the product, the manufacturer may affix it visibly and legibly only to the packaging.

In case a notified body was involved in the conformity assessment procedure the CE marking has to be followed by the identification number of the notified body in the same height as the CE marking.

Notified Body

A Notified Body (NB) is a third party designated by the competent authority of the EU member state, EEA member state or any other country that has concluded a Mutual Recognition Agreement (MRA) with the European Union to perform the conformity assessment tasks described in the Radio Equipment Directive (RED).

A list of appointed Notified Bodies is available on the European Commissions website including address details of each Notified Body as well as the tasks for which they have been notified.

If the manufacturer has not applied or not fully applied the relevant parts of the applicable harmonised standard in order to cover Article 3.2 and 3.3 of the Radio Equipment Directive (RED), the manufacturer or his authorized representative must use a conformity assessment procedure involving a notified body. A list of all harmonized standards is available on the European Commission’s website, which also gives information on titles and references to harmonised standards in relation to the RED.

Please note that nevertheless the only valid list is the most recent one published in the Official Journal of the European Union.

For any other case it is the manufacturers own choice to perform the conformity evaluation of his radio product by involving a notified body on a voluntary basis.

Market surveillance

The Member States of the European Union are forced to take appropriate measures to ensure that radio equipment covered by the Radio Equipment Directive (RED) placed on the market complies with the requirements of the Directive. Those measures also include market surveillance activities.

USA

The Federal Communication Commission or short FCC is the US American government agency responsible for the regulation of interstate and international communications being either transferred by radio, television, wire, satellite or cable. The FCC implements and enforces the communications law and regulations that may be found under the Code of Federal Regulations (CFR) Title 47. Some of the regulations are listed below for your reference:

Part 15 - regulations for intentional, unintentional, or incidental radiators that are operated without an individual license
Part 18 – regulations for industrial, scientific, and medical equipment (ISM) emitting electromagnetic energy on frequencies within the radio frequency spectrum
Part 22 - requirements and conditions for licensed radio stations operating in the Public Mobile Services (e.g. GSM 850 MHz).
Part 24 - requirements and conditions for licensed PCS radio stations (e.g. GSM 1900 MHz).
Part 27 - requirements and conditions for licensed wireless communications services (e.g. LTE 1700 MHz).
Part 74 – regulations applicable to the Auxiliary and Special Broadcast and Other Program Distributional Services (e.g. wireless microphones).
Part 90 - requirements and conditions for licensed radio communications systems in the Public Safety, Industrial/Business Radio Pool, and Radio location Radio Services
Part 101 - requirements and conditions for licensed private operational, common carrier, 24 GHz Service and Local Multipoint Distribution Service fixed and microwave operations

Telecommunication Certification Bodies (TCBs)

As part of the facilitation of the continued rapid introduction of new and innovative products to the US American market, the Federal Communication Commission (FCC) established in 1998 the Telecommunication Certification Body (TCB) program. Together with a Mutual Recognition Agreement (MRA) signed between the USA and a foreign country, the program authorizes a private third party located in a country covered by the MRA to issue grants for certification of equipment subject to the Commission’s certification procedures. In 2014 the FCC updated their rules and resigned from issuing grants of certification by themselves. Thus the TCB is your contact in regards to product approval for the US American market, evaluating your device in accordance with the FCC rules and regulations and issuing the appropriate grant of authorization.

Procedure

The approval system in the USA is following a straight forward approach and encourages the manufacturer of a communication product to determine the applicable rules for his specific product, find the correct approval procedure to follow (see more explanations below), perform the compliance testing as required by the applicable rules, label the product and include necessary statements in the user manual.

The first step in determining the applicable rules is Part 2 of the FCC rules as it outlines the assigned frequency ranges and refers to the specific rule part. The applicable rule part indicates the approval procedure to follow as there are the Suppliers Declaration of Conformity Procedure (SDoC), which is the less demanding procedure, and the Certification Procedure, that requires the involvement of a so called TCB or Telecommunication Certification Body. It is good and recommended practice to perform the compliance testing at an accredited and recognized testing laboratory, a list of such test labs is available on the FCC website, to get evidence of the conformity of the product. Depending on the very nature of the applicable approval procedure the approval evidence may either be the SDoC issued by the responsible party or the grant of application for certification issued by the TCB. Again it depends on the applicable approval procedure if the approved device must show a unique identification, name or model number, if approved under the SDoC procedure or, if the certification procedure is applicable, has to be marked with the FCC ID, a unique identifier consisting of the 3 or 5 digit grantee code assigned by the FCC and representing the responsible party and the equipment product code assigned by the grantee himself consisting of up to 14 arabic numerals, capital letters and the dash or a combination thereof. Additional regulatory notices may be required in the user manual or on the product itself depending on the specific rule part to follow. Now the product is ready for manufacture, import and sale. Please be aware to track any changes or modifications of the device and evaluate them against the rules and regulations.

Japan

With the intend to streamline the conformity assessment procedures for a wide range of telecommunications equipment and facilitation of trade between the Japan and the European Union a Mutual Recognition Agreement came into force in January, 1st 2001.It is the first bilateral agreement on mutual recognition for Japan. It provides for the mutual recognition of Conformity Assessment Bodies (CABs) and mutual acceptance of the results of equipment certification procedures undertaken by those bodies in assessing conformity of equipment to the importing economy's technical regulations.

Registered Certification Body (RCB)

In an effort to simplify the administrative work for licence applications and to alleviate the burden for applicants the Technical Regulations Conformity Certification System was established. In this system a Registered Certification Body (RCB) registered by the Minister for Internal Affairs and Communications certifies specific radio equipment such as Wireless Local Area Network (Wlan) devices or automotive radar devices in accordance with the applicable ordinances of the Ministry of Internal Affairs and Communications as conforming to technical regulations prescribed in the Radio Law. The Registered Certification Body (RCB) is the body that conducts inspection of radio equipment under foreign statute to ensure that a specified radio equipment to be used in Japan complies to the technical standards of the Japanese Radio Law.

Procedure

Certified specified radio equipment will be granted either a simplified license application procedure, which does not require an inspection after the completion of construction work, a blanket license that covers specified radio stations, or will not require a license, depending on the type of the equipment. Specific levels of regulations exist that govern approvals for wired and wireless equipment and that are structured as laws and ordinances. The Ordinances contain the technical requirements and the process for approvals (conformity assessment). Specified Radio Equipment is categorized as one of the following:

Category 1: Unlicensed station: 17 classes (Specified Radio Equipment specified in Article 38-2, paragraph 1, item 1 of the Radio Act). These are generally low power (< 1W) devices.
Category 2: Licensed station (Blanket License): 31 classes (e.g., mobile phones) (Specified Radio Equipment specified in Article 38-2, paragraph 1, item 2 of the Radio Act).
Category 3: Licensed station (Others): 75 classes (e.g., basestations) (Specified Radio Equipment specified in Article 38-2, paragraph 1, item 3 of the Radio Act).

Testing

In the context of the certification performed by the Registered Certification Body (RCB) the testing is conducted on one sample unit for each type of radio equipment (officially called "construction design"), for attestation of the construction design. In May 1998 the Minister for Internal Affairs and Communications extended the certification system targeting on the individual equipment by the implementation of a new attestation system for the construction design (by type) of mass-manufactured equipment.

Labeling

Each approved product must show a certification mark consisting of a three digit identifier for the Registered Certification Body (RCB), a hyphen and six digits identifying the specific product. The label is completed by adding the Technical Conformity Mark showing a stylized transistor.

Canada

Innovation, Science and Economic Development Canada, short ISED, is mandated to improve the productivity and competitiveness of the Canadian Industry. Their Certification and Engineering Bureau therefor provides a certification service for radio equipment as well as a registration service for terminal equipment. Testing of either radio or terminal equipment, to establish compliance with Innovation, Science and Economic Development Canada standards, is performed in private sector laboratories. To minimize the impact of the operation of various radio apparatus to each other the Innovation, Science and Economic Development Canada prescribes technical standards that each radio device manufactured, imported or sold in Canada must meet. This also includes compliance with the limits set forth by Health Canada on the exposure of radio frequencies and the Specific Absorption Rate (SAR). A list of all radiocommunication equipment certified for use in Canada is provided by ISED Certification and Engineering Bureau in the Radio Equipment List (REL) database.

Foreign Certification Body (FCB)

On November 11th, 1998 Canada and the European Community signed a Mutual Recognition Agreement. With this document Innovation, Science and Economic Development Canada (ISED) recognizes foreign certification bodies (FCB) to certify products for the Canadian market in accordance with the regulatory requirements set out by ISED.

Procedure

All Radio apparatus, interference-causing equipment and Terminal equipments are subject to Canadian regulations where as the technical regulations set out by Innovation, Science and Economic Development Canada (ISED) can apply to the types of equipment described below. Radio apparatuses are devices or combinations of devices intended for , or capable of being used for, Radiocommunication (includes a broad range of equipment from remote car alarms to high-powered broadcast transmitters). Interference-causing devices covers equipment, machinery or devices, other than radio apparatus, that can cause interference to Radiocommunication (includes digital equipment that uses a microprocessor or microcontroller, and Industrial, Scientific and Medical equipment such as switching power supplies used in halogen lamps). And finally terminal equipments are apparatuses such as a wired telephone or modem that can be connected to telecommunications networks of Canadian carriers; and used by a telecommunications service subscriber at their premises. The equipment is subject to different technical regulations based on the category of the equipment. Category I equipment (most radio apparatus) must meet technical regulations and requires certification by Innovation, Science and Economic Development Canada or a Certification Body. All Category I equipment for use in Canada must be labelled with the applicant's name (i.e. manufacture's name, trade name, or brand name), model number and certification number. Category I equipment includes but is not limited to Broadcasting transmitters, digital scanner receivers, cellular phones, cordless phone, model aircraft remote control, remote car Garage door openers and wireless routers. Category II equipment must meet technical regulations but certification is not required. The manufacturer, supplier or importer shall nevertheless ensure that the regulations are complied with. The equipment shall also be properly labelled according to the applicable standards. Category II equipment includes but is not limited to Electronic transformers or ballasts, alarm keypads, intelligent battery chargers, satellite TV receivers, VCR’s, DVD players, computers, or any equipment that generates and uses timing signals at a rate in excess of 10,000 pulses per second. And finally Terminal equipment must comply with Innovation, Science and Economic Development Canada technical regulations and must be registered with Innovation, Science and Economic Development Canada.

Canadian Representative

A Canadian representative is required when the applicant's company address is not within Canada. The applicant must provide a signed Applicant-Canadian Representative Agreement and the details of the company representative in Canada shall be clearly identified. The Canadian representative shall be responsible for responding to all enquiries from Innovation, Science and Economic Development Canada regarding the certified equipment, including providing audit samples at no charge to Innovation, Science and Economic Development Canada. The applicant must have a valid Applicant Canadian Representative Agreement for as long as the certified equipment is offered on the Canadian market.

Labeling

Prior to marketing, for products manufactured in Canada, and prior to importation for products imported to Canada the manufacturer, importer or distributor shall meet the labelling requirements set out by Innovation, Science and Economic Development Canada (ISED). Specific requirements apply for using an electronic label. Every unit of a certified product shall bear a label showing the Hardware Version Identification Number (HVIN) and the ISED certification number. The Product Marketing Name (PMN) must be displayed electronically (e labelling), or indicated on the exterior of the product or product packaging or product literature, which shall be available with the product or online. The PMN, HVIN and ISED certification number are permitted to be etched, engraved, stamped, printed on the product, or permanently affixed to a permanently attached part of the product. The certification number consists of a 5 numeric character Company Number (CN), assigned by Innovation, Science and Economic Development Canada's Certification and Engineering Bureau, followed by the 11 alphanumeric character Unique Product Number (UPN) assigned by the applicant. The CN and UPN are limited to capital alphabetic characters (A Z) and numerals (0 9) only. The use of punctuation marks or other symbols, including "wildcard" characters, is not permitted. In case the dimensions of the product are extremely small or if it is not practical to place the label or marking on the product and electronic labelling has not been implemented, the label shall be placed in a prominent location in the user manual supplied with the product. The user manual may be in an electronic format and must be readily available.