Various countries mean different regulations. The interactive map shows the differences in the world and the telecom authorities in charge.
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The Regulatory Compliance Mark (RCM) is a mandatory approvals mark for Telecom, Electrical and Wireless products in Australia and New Zealand. It is a combined mark covering EMC, Radio, Telecom, electromagnetic radiation (EMR) and Electrical Safety regulatory requirements.
The Regulatory Compliance Mark (RCM) is a mandatory approvals mark for Telecom, Electrical and Wireless products in Australia and New Zealand. It is a combined mark covering EMC, Radio, Telecom, electromagnetic radiation (EMR) and Electrical Safety regulatory requirements.
The UK Conformity Assessed mark will be a mandatory mark on a product to indicate that it conforms to UK legislation. The manufacturer or their authorised representative will be responsible for affixing the UKCA mark to the product, which is the same principle as for CE marking but for the UK market.
General Requirements for Compliance of Interference-Causing Equipment, sets out general requirements that are common and applicable to all categories of interference-causing equipment unless stated otherwise in the corresponding ICES standard.
The FCC maintains jurisdiction over the areas of broadband access, fair competition, radio frequency use, media responsibility, public safety, and homeland security. The FCC was formed by the Communications Act of 1934 to replace the radio regulation functions of the Federal Radio Commission.
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 EU legislation and the product may be sold anywhere in the European Economic Area (EEA).
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.
TRA is responsible for managing and regulating the wireless services in the UAE, including Allocating and assigning spectrum for all Radio services
CITRA oversees four ICT subsectors, and they are:
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 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 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.
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 The Ministry of Information and Communication Technology in the sector of Radio and Communication Regulatory so that as a supervisory foundation, it could pave the grounds for competitive market of telecommunication and increment, promotion and optimization of service quality.
Under the Telecom Act 1996 (section 29), no terminal equipment can be directly or indirectly connected with the public switched network unless it has been type-approved by PTA. Type approval granted by PTA (Pakistan Telecommunication Authority) signifies that particular telecommunication equipment is approved for general sale and is suitable to connect with a specific public telecommunication network
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.
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.
Created by Law No. 88-145 of 31 December 1988, the CERT began operations in February 1991with the aim of sustainable development of the telecommunications sector and to support activities of the major ICT players.
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.
The role of the Regulatory Authority is to promote the development of the postal and electronic communications sectors through various actions.
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 Regulatory Agency for Telecommunications (ARCT) is responsible for regulating communications in Burundi. ARCT regulates by processing applications for licenses, establishing standards for equipment and operation, arbitrating disputes, ensuring fair competition, and managing the frequency spectrum.
The National Regulation Authority of Information and Communications Technology (ANRTIC) regulates ICT in Comoros. The ANRTIC approves tariffs, enforces fair competition, promotes low prices, manages frequencies, approves equipment, ensures operators’ compliance with legislation, and also promotes the interests of consumers.
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 ECA was established by the Communications Services Proclamation No. 1148/2019 as an independent Federal Government Authority, with a commitment to facilitate the restructuring, the development and the integration of the Telecommunications, Information and Communications Technology (ICT), Electronic Commerce as well as Postal and Courier services to form a well-regulated, operated and efficient Communications Services sector.
The Communications Authority of Kenya (CA) is the regulatory authority for the communications sector in Kenya. Established in 1999 by the Kenya Information and Communications Act, 1998, the Authority is responsible for facilitating the development of the information and communications sectors including; broadcasting, cybersecurity, multimedia, telecommunications, electronic commerce, postal and courier services.
The Communication Technologies Regulatory Authority (ARTEC) is a public industrial and commercial establishment (EPIC) instituted by decree n ° 2006-213 of March 21, 2006. The headquarters of ARTEC is located in Alarobia, Antananarivo .
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 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 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.
♦Set appropriate technical standards and rules to ensure interoperability, efficient use of radio spectrum and telephone numbers. Its main mandates are:
♦Managing access to the radio-frequency spectrum and monitoring their usage;
The Authority for Info-communications Technology Industry (AITI) is a statutory body which is responsible for:
AITI was established on 1 January 2003 by the AITI Order 2001 to function as a telecommunications regulator, national radio-frequency spectrum manager and developer of Brunei Darussalam’s ICT industry
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).
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.
NICTA regulates broadcasting, radiocommunications and telecommunications.
NICTA was established on the 29th of October, 2010, as the sole converged regulator and licensing authority of the ICT industry in PNG. This followed the adoption by the PNG Parliament in November 2009 of the National Information and Communications Technology Act 2009 (the NICT Act) a subsequent creation of the National Information and Communications Technology Authority or NICTA.
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.
TRCSL will promote sustained development in the telecommunication industry by shaping the regulatory process, protecting the public interest and being responsive to challenges in an increasingly competitive market.
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 Azerbaijan State Ministry of Communications is in charge of the use of the radio spectrum for civilian use, registration of radio-electronic facilities operating on these frequencies in the territory of the Republic. They Conduct radio monitoring and control ether to ensure electromagnetic compatibility and eliminate interference for the normal operation of radiocommunications equipment.
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 Ministry of Communications and Informatization of the Republic of Belarus (hereinafter referred to as “Minsvyazi”) is a republican body of state administration and carries out government regulation and management of the activities in the domain of communications and informatization, coordinates the activities of legal persons regardless of their patterns of ownership and individual entrepreneurs in the domain of communications and informatization.
Most products entering Kazakhstan’s markets must meet the requirements of Kazakhstan’s certification system. The local laws and product regulations are generally put in place to provide assurance that the products and services are safe, of good quality and fit for consumers’ needs. Decision No 367 contains the list of products (including radio and telecommunication products), which are subject to conformity assessment within National System of Conformity Assessment of Kazakhstan, has been cancelled, however EAEU technical regulations are applicable.
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.
A party intending to manufacture, sell or import broadcasting and communication equipment must have one of those three certifications.
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 Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health(link is external), and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.
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 EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. As these regulations did not take effect during the transition period, they were not EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain. This means that the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain and will not be implemented in Great Britain.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
As from may 26th 2021, there is no MRA between the EU and Zwitserland with respect to the regulation EU 2017/745. This means that until further notice the Directive 93/42/EEC is applicable and a separate local Authorized representative in Zwitserland will need to be appointed.
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a ‘New Approach’ Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers’ products meeting ‘harmonised standards have a presumption of conformity to the Directive and must place the CE mark.
The Republic of China Food and Drug Administration (FDA; Chinese: 食品藥物管理署) is a Republic of China government agency, which is responsible for the safety and quality of food, drug, medical service and cosmetics. It is part of the Ministry of Health and Welfare. FDA is a regulatory member of ICH association.
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
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 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
(Rospotrebnadoz). is the competent authority and is responsible for registration, clinical safety and efficiency of all medical devices. Gosstandart ensures that all medical devices meet established Russian standards. Rospotrebnadoz is responsible for ensuring that all medical devices that come into contact with
the human body, or which may otherwise negatively affect patients or doctors, meet sanitary and
epidemiological regulations.
Medical devices (except for custom made devices) are subject to state registration, which
must be carried out by the Federal Surveillance Service of Healthcare.
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.
In addition to drug products, the COFEPRIS is in charge of food and beverages, tobacco products, other healthcare supplies (medical devices, vaccines, blood and tissues, etc.), healthcare services, cosmetics and other consumer goods, pesticides, plant nutrients and toxic substances, national health emergencies, occupational health and environmental risks.
Foreign manufacturers without a location in Mexico must appoint a License Holder (LH) authorized by the COFEPRIS through an “Operation Notice” (Aviso de Funcionamiento).
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.
A local Authorized Representative needs to be assigned te be able to register your product at ANMAT.
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.
All Medical Devices and their accessories that will be supplied to the KSA market require SFDA Medical Devices marketing Authorization.
Medical device marketing authorization applications shall be made to the SFDA by either by a local manufacturer or where the manufacturer is established outside the KSA, by its authorised representative.
The Ministry of Health of the Republic of Belarus performs registration of finished medicinal products and active pharmaceutical ingredients, medical equipment and medical devices based on the expert evaluation carried out by the Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care” of the Ministry of Health of the Republic of Belarus.
Medical devices and medical equipment of foreign manufacture may be imported and marketed in the territory of the Republic of Belarus after state registration. Currently Application form for registration may be submitted both under “national” Belarusian and under “unified” procedure of EAEU.
Certificate has validity for 5 years and a Local Authorized representative is not required.
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.
The manufacturer shall designate a local Authorised representative.
All documentation shall be made available in the Ukrainian language.
Medical product registration requires a local Authorised Representative.
Issued registrations do not have any validity limits.
Licenses are limited to 5 years for Class B, C and D products. Class A products do not have a limit. All documents need to be available in Vietnamese.
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 classification rules shall be based on the ASEAN Medical Device Directive.
An authorised representative is required who is responsible for placing medical devices on the market to be licensed by the Regulatory Authority
The responsibilities of the Institute for Public Health, department of
medical devices include: Authorize and control entities that perform compliance verification and certification of medical devices subject to health control.
Any person who intends to manufacture, import, market or distribute a
medical device must first obtain the conformity certificate with authorization by the Institute of Public Health of Chile.
A local representative is required.
The regulator for registration of medical devices in Morocco is the la commission nationale consultative des dispositifs médicaux.
In Morocco medical devices must meet a high safety level of use for the patient, professional and meet the essential requirements of quality, safety and performance set by regulation. One must receive a certificate of registration before one may place a medical device on the market. Certain medical devices are exempt from the registration
requirement, including device intended for experiments/research and custom-made ones.
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.
All importers of medical devices – be they subsidiaries, agents, ‘private label’ suppliers, parallel importers, or direct importers – have obligations that must be met when supplying products in New Zealand.
The Medicines Act 1981 and its Regulations control the supply of medical devices in New Zealand. However some medical devices may be impacted by other legislation and regulations which must also be complied with before the devices may be legally supplied. It is the supplier’s responsibility to ensure that their products comply with all applicable legislation.