The Internet of Things Global approval overview
The Internet of Things approval process for your devices can be a puzzle.
Various countries mean different regulations. The interactive map shows the differences in the world and the telecom authorities in charge.
An approval process can be cumbersome but is a daily job for IoT Consulting Partners by offering our IoT GoGlobal service.
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The Internet of Things goes global, so does your device.
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- The Internet of Things Radio overview
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IoMT Regulations globally
The FCC
The Federal Telecommunications Institute is an independent government agency of Mexico charged with the regulation of telecommunications and broadcasting services. It was formed on September 10, 2013, as part of larger reforms to Mexican telecom regulations, and replaced the Federal Telecommunications Commission.
MIC (Minister for Internal Affairs and Communications of Japan) Radio Technical Regulations Conformity Certification was established to achieve simplification and rationalization of administrative work for license application and to alleviate the burden borne by license applicants.
The CE mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant 
CITC is responsible for regulating the ICT sector in the Kingdom of Saudi Arabia The Telecommunications Act, issued by Royal Decree in 2001, provide the legal framework for organizing this sector. This Act involves a number of objectives such as: Providing advanced and adequate telecommunication services, using frequencies effectively, localization of telecommunication technology.
Any Local or International Manufacturer, Licensed Operator, Authorized Importer, Local dealer, or Persons (individuals or companies) in Qatar wishing to import RTTE for their own use (i.e. not for marketing/commercial purposes) can apply for type approval. A type approval certificate is granted if the equipment complies with the standards recognized by CRA (Simplified and Standard).
TRA is responsible for managing and regulating the wireless services in the UAE, including 
The Communication and Information Technology Regulatory Authority (CITRA) was established in 2014 and is responsible for overseeing the telecommunications sector, monitor and protect the interests of users and service providers and regulate the services of telecommunication networks in the country while ensuring transparency, equality of opportunity and fair competition.
The Telecommunications Regulatory Authority (TRA) is mandated to license telecommunications equipment to be used in Oman. This includes undertaking all the necessary procedures to ensure the compliance of this equipment used in the telecommunications network with the relevant technical specifications accepted in Oman.
Type Approval of Telecommunication Equipment utilized in Public Telecommunications Networks in the Kingdom of Bahrain will be granted to a device or apparatus that meets a minimum set of regulatory, technical and safety requirements. The Telecommunications Regulatory Authority (TRA) approve equipment for connection to a Telecommunication Network in accordance with Article 38 of the Telecommunications Law.
The market approval for the Kingdom of Jordan is based on the national requirements of the local authority 
The Telecommunications Sector Assessment Note in the Palestinian territories is a knowledge product prepared by the World Bank in response to a specific request from the Palestinian Ministry of Telecommunications and Information Technology (MTIT) to assess the performance of the telecommunications sector, identify specific issues and make recommendations for further development and reform.
The Ministry of Communications in Israel is responsible for setting policy, opening up the communications market to competition and developing communications infrastructures. The ministry is responsible for supervising and licensing communications providers, including Bezeq, the Postal Authority, cable and satellite companies, frequency management and the use of end devices.
The TRA mission is to establish a regulatory environment that enables a competitive telecommunications market to deliver state-of-the-art services at affordable prices to the broadest spectrum of the Lebanese population. The Telecommunications Regulatory Authority (TRA) was established in accordance with 
The Type Approval system is a procedure for registering a certain type of RTTE “Radio & Telecommunications Terminal Equipment” within the Syria Arab Republic without causing any interfering or damaging to telecom networks and to conform to “specific standards to be registered in SyTRA before they are sold or used” is a mandatory prerequisite.
The Communications and Media Commission (CMC) is the sole entity responsible for issuing licenses for the use of telecommunication devices in Iraq and for allocating frequencies. CMC has developed a new method of type approval includes the procedures and standards required. Entities who are willing to import telecommunication devices shall apply for the CMC to obtain a permit for importation in accordance with relevant technical specifications accepted in Iraq.
The Ministry of Telecom and Information Technology is in Yemen responsible for issuing the type approvals on wireless devices. The MTIT follows a procedure for final devices and modular approvals and per type.
Communications Regulatory Authority (CRA) was established in 2003 by virtue of article 7 of Law of Scope of Duties and Powers of Ministry of Information and Communications Technology, by a combination of Deputy minister for Telecommunication Affairs Department and Directorate General of Telecommunications. The aim of establishing of CRA was to execute governmental powers as well as supervision and executive powers of 
Nepal Telecommunications Authority is the telecommunications regulatory body of Nepal. It is an autonomous body established on Feb 1998 in accordance with the Telecommunications Act, 1997 and Telecommunications Regulation, 1998. The NTA is responsible for regulating all matters related to telecommunications of Nepal.
The Information and Communication Technologies Authority (ICTA) (Turkish: Bilgi Teknolojileri ve İletişim Kurumu (BTK)), is a national telecommunications regulatory and inspection authority of Turkey. It was formerly known as the Telecommunications Authority (Turkish: Telekomünikasyon Kurumu (TK)).
BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto.BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing.
The National Telecommunications Regulatory Agency’s responsibilities include issuing licenses for the operation of radio networks, Type approving telecommunications equipment, managing .ma domain names, receiving declarations of value-added services and processing all aspects of electronic certification.
The Research and Studies Telecommunications Centre (CERT) is a public service provider under the Tunisian Ministry of Information Technology and Communication.
The Regulatory Authority of the Post and Electronic Communications (ARPCE) hereinafter referred to as “Regulatory Authority” is an independent institution endowed with legal personality and financial autonomy, created by law n ° 2000-03 of 5 Joumada El Oula 1421 corresponding to August 5, 2000, amended and supplemented, setting the general rules relating to post and telecommunications, repealed by law n ° 18-04 of 24 Chaâbane 1439 corresponding to May 10, 2018 establishing the general rules relating to mail and electronic communications.
General Authority for Communications and Informatics (CIM) is mandated to license telecommunications equipment to be used in Libya. This includes undertaking all the necessary procedures to ensure the compliance of this equipment used in the telecommunications network with the relevant technical specifications accepted in Libya.
The National Telecom Regulatory Authority (NTRA) was established following the provisions of Telecom Regulation Law No. 10/ 2003 as the national authority competent to regulate and administer the telecommunications sector. NTRA, according to the Law, aims to enhance and deploy services in compliance with the most advanced technologies, satisfying the customer’s needs at the most appropriate prices, taking into consideration transparency, open competition, universal service and the protection of customers rights.
The Post and Telecommunications / ICT sector plays a key role in socio-economic development in any country, especially when it is based on the service economy. In the past, the Post and Telecommunications services were managed around the world by state enterprises in a monopoly position. Over the past two decades, this sector has experienced unprecedented development with market globalization. The MCPT is responsible for licensing and certification in Djibouti.
The Ethiopian Communications Authority (ECA) is the regulatory authority for Communications Services in Ethiopia. Its scope of regulation covers both Telecommunications Services and Postal Services within Ethiopia.
The Malawi Communications Regulatory Authority is the communications regulatory authority in Malawi. It was established as an independent regulatory organization in 1998 as part of the Communications Act. It oversees Malawi’s Telecommunications, Broadcasting, Postal Services, and Internet.
The three main aspects of radiocommunications are radiofrequency planning, spectrum monitoring and radio frequency safety. The ICT Authority is empowered under section 18 (1) (p) of the ICT Act 2001, to “allocate frequencies and manage, review, and, where appropriate, reorganize the frequency spectrum.” The Authority also has as a function under section 18(1) (r) of the ICT Act 2001, to “set up a radio frequency management unit for the allocation, monitoring, control and regulation of radio frequencies and, with the approval of the Minister, participate in any regional monitoring system.” The main duties of the Authority in the field of radiofrequency planning are:
The Communications Regulatory Authority-INCM has, for the purpose, the regulation, supervision, inspection, sanctioning and representation of the postal and telecommunications sectors, as well as the management of the radio frequency spectrum and numbering. The INCM is subject to the supervision of the minister responsible for the communications area, enjoying administrative autonomy (ability to carry out its own administrative acts), financial autonomy (ability to decide its expenses and budget) and assets (ability to have its own assets) and powers of action and appropriate powers for decision making by the same.
The Rwanda market for Information and Communication Technologies is characterized by a high evolution and demand for services across the socio-economic spread of the country. Enhancement in the use of ICT requires a proper regulatory framework to create an environment that promotes public confidence and ensure stability, transparency, competition, investment, innovation, and growth in the ICT sector. RURA’s mandate, among other things, within the ICT sector is to license, monitor and enforce license obligations, manage scarce resources, advise policymakers on ICT related issues and represent Rwanda in international organizations on issues pertaining to ICT.
The National Communications Authority (NCA) is the regulatory body for the communications sector in Somalia. NCA was established through the Communications Act of 2017 and its mandate is to regulate the Communications sector including telecommunications, Internet, broadcasting, Information and Communications Technology, eCommerce services. The NCA is responsible for facilitating the development of the ICT sector, enabling and ensuring fair and sustainable competition, carrier interconnection, transparency in the implementation of the Communication Law, protecting consumer interest and rights, and maintaining its role as an independent regulator.
NCA establishment was in June 2015 when the Board of Directors had its first inaugural meeting. NCA is now operational and carrying out its regulatory functions effectively. It has enacted ten regulations (bylaws) for the different aspects of the ICT sector, managing the country spectrum resources, numbering plan, approving tariffs, tackling interconnection issues and disputes, licensing ICT service providers and approving equipment types and standards.
The Telecommunication and Postal Regulatory Authority (TPRA) is mandated to license telecommunications equipment to be used in Sudan (KHARTOUM). This includes undertaking all the necessary procedures to ensure the compliance of this equipment used in the telecommunications network with the relevant technical specifications accepted in Sudan.
The Tanzania Communications Regulatory Authority (TCRA) is a quasi-independent Government body responsible for regulating the Communications and Broadcasting sectors in Tanzania. It was established under the Tanzania Communications Regulatory Act No.12 of 2003 to regulate the electronic communications, and Postal services, and management of the national frequency spectrum in the United Republic of Tanzania. The Authority became operational on 1st November.
The Uganda Communications Commission is the government regulatory body of the communications sector in Uganda. Although owned by the Ugandan government, it acts independently.
The Zambia Information and Communications Technology Authority (ZICTA) is a regulatory body responsible for regulating the ICT industry in Zambia. It is authorised by three Acts — the Electronic Communications and Transactions Act No. 21, the Information and Communications Technologies (ICT) Act No. 15 of 2009, and the Postal Services Act No. 22 of 2009 — and regulates ICT, postal and courier services in Zambia.
Postal and Telecommunications Regulatory Authority of Zimbabwe (POTRAZ) was established by the Postal and Telecommunications Act in 2000 and started its operations in March 2001. This legislation brought about a new institutional framework for telecommunications in Zimbabwe.
The Bhutan InfoComm and Media Authority (BICMA) is an autonomous government agency established as per the provisions of the Information, Communications and Media Act of Bhutan 2018. BICMA is a converged regulatory body responsible for the regulation of the Information, Communications and Media sector in Bhutan.
The Authority for Info-communications Technology Industry (AITI) is a statutory body which is responsible for:
To promote effective network infrastructure connectivity and accessible services of Post, Telecommunications, and ICT sectors across the Kingdom of Cambodia, the region and the world in order to contribute to socio-economic development and poverty reduction.
Office of the Communications Authority (OFCA) is an executive arm of Communications Authority in Hong Kong. It is the body responsible for telecommunications regulation (through the Regulatory Affairs Branch), antitrust enforcement (through the Competition Affairs Branch) and allocation of the radio frequency portion of the electromagnetic spectrum (also known as spectrum management, through the Operations Branch).
The regulator and standardizer in Indonesia is the Directorate General of Resources and Equipment Standardization for Post and Informatics (SDPPI). The standardization as a support element for the development had an important role in an Optimization effort The efficient use of all resources and all development activity. Standardization equipment including management and supervision really had a role in increasing the domestic and international trade, the national industry development, as well as the protection against the user (the operator and the community).
In Laos, it is the Ministry of Post and Telecommunication (MPT) of Laos that has been established in 2011 and plays the role of policymaker, regulator and monitoring the ICT developments.
SIRIM Berhad, formerly known as the Standard and Industrial Research Institute of Malaysia (SIRIM), is a corporate organisation owned wholly by the Malaysian Government, under the Minister of Finance Incorporated. It has been entrusted by the Malaysian Government to be the national organisation for standards and quality, and as a promoter of technological excellence in the Malaysian industry. The main headquarters is located in Shah Alam, Selangor.
Communications Authority of Maldives (CAM) was established as a separate entity with a mandate of regulating the telecommunications and postal sector, to create a conducive environment for promoting competition in telecommunication and postal services and developing the sector in accordance with the national laws, polices and regulations.
On Aug. 19th, 2019 Communications Regulatory Commission of Mongolia (CRC) issued Resolution No. 29 regarding the Type Approval Regulatory guidelines for Information and Communication equipment. Under this regulation, most Wireless and Telecom equipment will need to apply for CRC Type approval.
The National Information and Communications Technology Authority (NICTA) is a government agency responsible for the regulation and licensing of Information Communication Technology (ICT) in Papua New Guinea.
The Philippines’ National Telecommunications Commission, abbreviated as NTC, is an attached agency of the Department of Information and Communications Technology responsible for the supervision, adjudication and control over all telecommunications services and television and radio networks throughout the country.
Telecommunication and radio-communication equipment to be sold for local use in Singapore is subject to equipment registration with IMDA. Prior to registering the equipment with IMDA, please ensure that the equipment complies with the relevant IMDA Standards/Technical Specifications.
The Telecommunications Regulatory Commission of Sri Lanka (TRCSL) was established under the Sri Lanka Telecommunication (Amendment) Act No. 27 of 1996 as the national regulatory agency for telecommunications in Sri Lanka.
Ministry of Information and Communications is the government ministry in Vietnam. It is responsible for state administration of newspapers; publishing; posts; telecommunications and internet; broadcasting; radiofrequency; information technology, electronics; radio, television and national media infrastructure.
The NBTC was established under the Act on the Organization to Assign Radio Frequency and to Regulate the Broadcasting and Telecommunication Services B.E. 2553 (2010). The NBTC is the independent state Broadcasting and telecommunications regulator. Its duties and responsibilities are to regulate all broadcasting and telecommunication services in the country through formulating a master plan on broadcasting and telecommunications activities.
The requirement for the Network Access License (NAL) is an SRRC Type Approval (State Radio Regulation of China, SRRC). The responsible authority for radio transmission equipment is the State Radio Monitoring and Testing Center (SRTC). Among other tests, this authority is also responsible for safety tests of radio transmission equipment for the CCC certification.
The regulation in Taiwan for products with wireless technology are as strict as in most other regions. All telecommunications products and other products with radio and wireless technology must conform to the administrative and technical requirements of Taiwan and need to be approved before they can enter the market legally. The minimum requirement for these products is the NCC Certification.
By order of the National Commission for the State Regulation of Communications and Informatization, the UCRF performs international protection and coordination of radio frequencies, takes part in inactivity of the International Telecommunication Union. As well, on request of the Commission, the UCRF participates in performing the state supervision of compliance with frequency use legislation.
The Ministry of Industry and Trade of the Russian Federation is a government ministry of Russia. Its headquarters are in Moscow. The ministry regulates foreign trade, defence and civil industries, metrology, technical standardization, and aviation technology development. It is a federal executive body.
The Main State Standards Service (Turkmenstandardlary) is the regulating agency in the area of standards and metrology in Turkmenistan. There are no other standard organizations. Turkmenistan became a member of the International Standard Organization (ISO) in 1993.
Electrical and telecom products are regulated with the law of Tajikistan “on the conformity assessment” and must meet the requirements of the technical regulations on the safety and relevant EMC standards of Tajikistan.
The State Agency for Communications of the Kyrgyz Republic (SAC KR) is the public authority regulating communications sphere (telecommunications). The SAC KR has the authority to issue licenses for telecom services and permits to import and operate ra¬dio electronic equipment and high frequency devices, certify telecommunication equipment and devices, supervise compliance with legislation and license conditions, assure proper services and operations in the sector.
The conformity assessment procedure in Armenia is in line with the European RE Directive however based on the decision No. 2228 on the Technical Regulations for Radio and Telecom equipment. Local Certification is required.
The state policy in the field of certification is regulated by the Uzbek agency of standardization, metrology and certification, which is the national certification body of Uzbekistan. The agency establishes general rules for the certification, publishes official information about the regulations, determines the list of products subject to mandatory certification.
The Regulatory Agency for Electronic Communications and Postal Services (RATEL) ensures the efficacy and quality of communications in the Republic of Serbia. RATEL implements legislation and regulatory frameworks for communications operators. The agency also promotes competitiveness nationally and internationally. The RATEL site contains information about regulations, the Telecom market, and quarterly electronic communications reports.
On November 13, 2017 decision No. 807 of 29.10.205 came to force, by which the government of Moldova has established the new Technical Regulation on “Electromagnetic Compatibility of Equipment.” Through this regulation, The Ministry of Economy recognizes the bodies performing the conformity assessment of the electromagnetic compatibility of the equipment for the national market and establishes their requirements when conducting conformity assessment procedures.
The broadcasting and communication equipment conformity assessment system has been implemented according to Article 58-2 of the Radio Waves Act. It is divided into the certification of conformity, registration of compatibility, and interim of conformity.
The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients.
The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices, four sub zonal offices, thirteen Port offices and seven laboratories spread across the country.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. For Medical Devices the MHRA follows the MDD 93/42/EU until June 2023.
The Republic of China Food and Drug Administration (FDA; Chinese: 
The regulator is Ministry of Health, Labor and Welfare (MHLW), the one doing the technical support for MHLW is Pharmaceutical and Medical Device Agency (PMDA). The rule for medical device in Japan is Pharmaceuticals and Medical Devices Act (PMD Act) which came into force on Nov 25, 2014. The entity who file the product registration has to be a local company in Japan and is the holder of the certificate.
The regulator is National Medical Products Administration (NMPA). The rule is the Medical Devices Supervision and Management Act published by the General Office of the State Council. All medical device has to be registered or certified by NMPA or local office of NMPA. For overseas medical device, it is required to be registered on NMPA for class 1 medical device and certified by NMPA for class 2 and 3 medical devices. The filing has to be made by a local company for overseas manufacturer. Assessment of quality management system may be required for NMPA registration certificate. The certificate is valid for 5 years.
The regulator for medical device in Brazil is The Brazilian National Health Surveillance Agency (ANVISA). The regulation is RDC 185/2001 and RDC 40/2015. There are 4 classes for medical device in Brazil. The market authorization has to be granted by ANVISA before the medical device being placed in the Brazil market. Only the local company is allowed to apply market authorization for a medical device. The market authorization will not expire for class 1 and 2 medical devices unless it is cancelled. And for class 3 and 4 medical devices, it is valid for 10 years.
The regulator is the Medical Device Authority (MDA) under the Ministry of Health (MOH). The regulation is Medical Device Regulations 2012 based on the Medical Device Act 2012 (Act 737) came into force on 1st of July 2013. All medical device has to be registered, the applicant has to open an account on MeDC@St online service for such filing. The overseas manufacturer has to appoint an authorized representative to do this registration. Before registration, a quality assessment done by the Registered Conformity Assessment Body is required and an onsite audit will be required for class B, C and D medical device.
The regulator is Thailand Food and Drug Administration (TFDA), the regulation is Medical Device Act B.E. 2551 (2008). The Medical Device Control Division (MDCD) of TFDA is in charge of running the regulation and the Secretary-General of TFDA is the licensor. From 15th Feb 2021, the classification of the medical device has been re-defined to align with ASEAN AMDD. To place class 4 medical device in the Thailand market, you will need to follow licensing procedures, class 2/3, notify procedures and class 1 , listing procedure. The applicant has to be with Thailand contact address.
The regulator is the Directorate General of Pharmaceutical Service and Medical Devices under the Ministry of Health (MoH). Classification of the medical device follows ASEAN MDD. Online registration is required for the medical device to obtain a distribution number for the product. The overseas manufacturer has to authorize a local distributor for such registration. This distributor should be with MDDL and implement GDPMD. Onsite audit and clinical investigation are not required but the local test may be required for some of the medical devices. The registration license is valid until the authorization letter the overseas manufacturer issues to the local distributor expired, but maximum 5 years.
Federal Service on Surveillance (Roszdravnadzor) Federal Agency for Technical Regulation and Metrology (Gosstandart) Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection
COFEPRIS is the regulator for Medical Devices in Mexico. COFEPRIS stands for Comisión Federal para la Protección contra Riesgos Sanitarios: Federal Commission for Protection against Sanitary Risks and is the authority with competence to control and regulate drug products in Mexico.
ANMAT is the Argentinean medical device market regulator. The National Administration of Drugs, Foods and Medical Devices (ANMAT) is an agency decentralized from the Argentine National Public Administration . ANMAT cooperates in the protection of human health by assuring the quality of the products it regulates: drugs, foodstuff, medicinal products, diagnosis reagents, cosmetic products, dietary supplements and household cleaning products.
The regulator is Health Sciences Authority (HSA) and the regulation is Health Products Act (HPA). The rule is in Health Products (Medical Devices) Regulations 2010. Registration is required for medical device except for Class A device. The company that wants to produce, import and wholesale the medical device need to be with the Dealer’s License. Both registration and license can be applied on the MEDICS E-Services system. Only local company with CorpPass and assign a person in charge of CRIS can apply registration for a medical device. An overseas manufacturer can use HSA PIN to assign the people in charge, but that is for preparation only, not for registration filing. There are some evaluation routes for registration, full evaluation is not required if the medical device has been approved by Australia TGA, EU Notified Body, Health Canada, Japan MHLW or USA FDA.
Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no. (1) Issued on 10/3/2003, as an independent Authority reporting to the Council of Ministers. The SFDA aims to “ensure the safety of food, safety, quality and effectiveness of drug, and the safety, quality, effectiveness and performance of medical devices according to their intended purpose. Regulating medical devices, in vitro- diagnostic devices, prescription eye glasses, contact lenses and their solutions, are among the responsibilities of SFDA in accordance with its law issued by the royal decree No.(M/6) issued on 13/2/2007.
The application for state registration of a medicinal product is filed to the Ukrainian Ministry of Health Protection. The application for registration of the medicinal product should contain general information about the applicant, the manufacturer of said medicinal product, denomination of the product, a type of the product, storage conditions, etc.
In Korea the MFDS is in charge of the approval of medical devices, GMP standards, and pre- and post-market management of the medical device classification process.
In Vietnam, all medical devices are controlled by the Department of Medical Equipment and Health Works (DMEHW). DMEHW is part of the Ministry of Health (MOH). Before a device can be sold and distributed in the country registration is required. A license named marketing authorization (MA) license is also required before the sales.
The Philippines’ Food and Drug Administration (FDA), formerly the Bureau of Food and Drugs (BFAD), was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines.
The regulator in Chile for registering your Medical device is the Subdepartmento de Dispositivos Médicos, Instituto de Salud Publica.
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.