Introducción El uso de los dispositivos médicos para la prevención, el diagnóstico y el tratamiento de enfermedades o problemas físicos, el alivio de síntomas o la contracepción; los convierte en un elemento indispensable para los servicios de salud. Su diversidad…
Introduction The use of medical devices for the prevention, diagnosis, and treatment of diseases or physical problems, symptom relief, or contraception makes them an indispensable element of healthcare services. Their diversity and widespread use require an appropriate regulatory system to…
Regulatory authority The primary authority responsible for the regulation of medical devices in Jordan is the Jordan Food and Drug Administration (JFDA), an independent public institution established in 2003. When the JFDA was first established by Provisional Law No. 31…
Introduction The National Drug Authority (NDA) has a mandate to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use…
Regulatory authority The Botswana Medicines Regulatory Authority (BoMRA) was established through the Medicines and Related Substances Act of 20131. BoMRA is responsible for regulating medical devices, including in vitro diagnostic medical devices (IVDs), to ensure compliance with strict standards for…
Regulatory authority The Saudi Food and Drug Authority (SFDA) is responsible for the administration of medical device regulation in the Kingdom of Saudi Arabia. It oversees the evaluation, classification, registration and licensing of all medical devices, as well as medicinal…
Regulatory authority The Ministry of Food and Drug Safety (MFDS) is responsible for medical device regulation in the Republic of Korea. It oversees the evaluation, classification, registration, and licensing of all medical devices. It is also responsible for reviewing and…
Introduction Mandatory Nicaraguan Technical Standard NTON 24001:2023, Health technology. Medical devices. Requirements for Health Registration1, was approved by the Technical Committee for Standardization on 31 October 2023. The purpose of this standard is to establish the requirements and provisions for…
Regulatory authority The Iranian Food and Drug Administration (IFDA) is an independent agency which operates under the Ministry of Health and Medical Education and oversees the evaluation, classification, registration, licensing, and importation of all medical devices. The head of the…
Introduction In Colombia, all medical devices must have a marketing authorisation, which is issued by the National Institute for Food and Drug Surveillance (INVIMA). INVIMA is an institute attached to the Ministry of Health and Social Protection and oversees the…
Resumen En Colombia, todos los dispositivos médicos deben contar con autorización de comercialización (registro sanitario), la cual es emitida por el instituto nacional de vigilancia de medicamentos y alimentos (INVIMA). El INVIMA es un instituto adscrito al Ministerio de Salud…
Regulatory authority State registration is a mandatory procedure necessary for the legal circulation of medical devices in the Republic of Serbia. The following authorities are involved in the approval and marketing of medical devices: Ministry of Health (www.zdravlje.gov.rs) is…
Introduction Medical devices, along with medicines, are basic elements of any healthcare system. Both medicines and medical devices need to be regulated in order to guarantee their quality, efficacy and safety when used by a patient. In Tunisia, medicines have…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
Overview of Mexico Mexico is a country with more than 125 million inhabitants and a wide diversity of medical conditions, most of them chronic and degenerative, such as cardiovascular disease, diabetes and cancer. To understand the Mexican market for medical…
Descripción general del país México es un país con más de 125 millones de habitantes, con una gran diversidad de padecimientos, la mayoría crónico degenerativos, como son las enfermedades cardiovasculares, diabetes, cáncer, entre otros. Para entender el mercado de los…
Regulatory authority The Ministry of Health, Drug and Food Control (MoH), through its Pharmaceutical and Herbal Medicines Control and Registration Administration, is responsible for medical device regulation in Kuwait. It oversees the evaluation, classification, registration and licensing of all medical…
Introduction The regulatory framework for medical devices, including in vitro diagnostic medical devices (IVDs), is the set of provisions that make up the technical, legal and regulatory basis that guarantees the safety, efficacy, performance and effectiveness of these products. This…
Introducción El programa regulador para equipos y dispositivos médicos, incluyendo los dispositivos médicos de diagnóstico in vitro (DMDIV), es el conjunto de disposiciones que forman la base técnica, legal y normativa que garantiza la seguridad, eficacia, desempeño y efectividad de…
Regulatory authority The Food and Drugs Authority (FDA) is the government agency responsible for medical device regulation in Ghana in addition to cosmetics, household chemical substances, food, drugs, herbal medicinal products, tobacco, blood and blood products, and the regulation of…
The idea of a common Eurasian medical device market The Eurasian Economic Union (EAEU) comprises Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan and has a combined population of more than 184 million. In its first five years, the gross domestic product…
Introduction The VietNamese healthcare market is in a time of change as the government seeks to invest in aging facilities and equipment while enticing foreign manufacturers with new, friendlier regulations. Seen as a high potential market, only specific medical devices…
Introduction The medical device industry has been largely unregulated in South Africa with the first medical device regulations introduced in 20161. As such, South Africa is still within the early stages of developing and implementing medical device regulations. The South…
Introduction At one time, there had been a State monopoly on all economic activities in Algeria, including those relating to pharmaceutical products and medical devices. Free healthcare was first introduced in 19741 and the 2018 Health Law continues this through…
Introduction À une certaine époque, il existait un monopole d’État sur toutes les activités économiques en Algérie, y compris celles relatives aux produits pharmaceutiques et aux dispositifs médicaux. La médecine gratuite a été instaurée en 19741 et la loi santé…
Introduction As the standard of living continues to rise in Thailand and around the world, people continue to demand better healthcare. Better healthcare can come in many forms, from early detection diagnostics utilising artificial intelligence to wearable technology. Heavily relying…
Regulatory authority The National Health Regulatory Authority (NHRA) is an independent regulatory body that was established in 2010 by Law No. 38 of 2009. The NHRA’s mission is to regulate the provision of healthcare in Bahrain and ensure appropriateness, continuity,…
Regulatory authority The Ministry of Health and Prevention (MoHAP) is responsible for the administration of medical device regulation in the United Arab Emirates (UAE). The Ministry oversees evaluation, classification, registration, and licensing of all medical devices, including in vitro diagnostic…
Regulatory authority The regulatory system for healthcare in the Republic of Peru is not segmented; there is a single national authority for pharmaceutical products and medical devices, including in vitro diagnostic medical devices (IVDs). That authority is the General Direction…
Introduction The agency in charge of regulating medical devices in Argentina is the National Administration of Drugs, Food Products and Medical Technology (ANMAT). ANMAT Disposition No 1285/2004 (restatement of Disposition 2318/2002) defines a medical device as any equipment, device, material,…
Regulatory authority The Central Administration of Pharmaceutical Affairs (CAPA) within the Egyptian Drug Authority (EDA) is responsible for overseeing the regulation of medical devices in Egypt. CAPA has overall responsibility for the evaluation, classification, registration and licensing of locally produced…
Introduction The agency in charge of regulating medical devices in Argentina is the National Administration of Drugs, Food Products and Medical Technology (ANMAT). ANMAT Disposition No 1285/2004 defines a medical device as any equipment, device, material, product or system of…
Market overview It is estimated that local manufacturers only meet 10% of the market demand for medical devices in Vietnam, while 90% of medical devices are imported, especially advanced technology like diagnostic imaging equipment. Local manufacturers have only been able…
Introduction Around the world, medical devices have become an integral part of modern healthcare and even daily life. These advancements are largely due to an influx of innovative, digital technology that has changed the medical device environment. Telephones, watches and…
Legislative framework Medical devices are governed by Supreme Decree No 825/98 (Regulations with Control of Medical Use Products and Elements1) and Decree No 725 (the Sanitary Code2). Legislation dates from 1997, when medical devices were included in the Sanitary Code.…
Regulatory authority The Competent Authority for medical devices in Zimbabwe is the Medicines Control Authority of Zimbabwe (MCAZ). This Agency is responsible for, inter alia, control and assessment of the quality of medical devices, and issuing registrations and distributor registration…
Introduction The regulatory requirements for market placement of medical devices in the Russian Federation are in a state of transition from the country’s domestic legislation to the rules of the Eurasian Economic Union (EEU). At present the two regulatory systems…
Instancias reguladoras El sistema regulatorio en la República de Panamá es altamente segmentado. No existe en estos momentos, una sola autoridad que emita Registro Sanitario o Autorización Pre-Mercado a todos los productos para la salud humana. Existen instancias separadas que…
Regulatory authorities The regulatory system in the Republic of Panama is highly segmented. At this time there is no single authority responsible for issuing health registrations or pre-market authorisations for all human health products. There are separate authorities that issue…
Introduction Knowledge of response times, requirements that must be met, trademarks and samples is crucial for obtaining sanitary registration of medical devices in the Dominican Republic, so it is important to understand the regulatory framework that underpins the registration of…
Regulatory authority Article 3 of the Pharmaceutical Affairs Act (PAA)1 authorised the establishment of the Taiwan Food and Drug Administration (TFDA) in 2010 within the Ministry of Health and Welfare (MoHW) to administer ‘medicaments’. According to Article 4 of the…
Instancias reguladoras El Ministerio de Salud (MSP) es el ente rector de la política pública de salud. La Agencia Nacional de Regulación Control y Vigilancia Sanitaria (ARCSA) realiza el control de registro sanitario de los dispositivos médicos y otros productos.…
Regulatory authority The Ministry of Health (MSP) is the governing body responsible for public health policy. The National Agency for the Regulation and Sanitary Surveillance and Control (ARCSA) controls the sanitary registration of medical devices, amongst other products. In addition,…
A period of public consultation has been held1 on proposals to amend Korea’s safety and adverse event reporting requirements in order to clarify: the procedure for the collection of safety-related information by specifying clearly what information must be submitted to…
Regulatory authority Health Canada is the Federal department responsible for reviewing medical devices and in vitro diagnostic devices (IVD devices) to assess their safety, effectiveness and quality before being authorised for sale in Canada. Within Health Canada, the Health Products…
Regulatory authority The State Health Care Accreditation Agency under the Ministry of Health is the Competent Authority for medical devices and in vitro diagnostic medical devices. Its main responsibilities include: the registration of medical devices; maintaining a medical device…
Regulatory authority Singapore’s healthcare regulatory framework consists primarily of: the regulator, which is the Ministry of Health along with its statutory boards; and the regulated, which are the public and private healthcare providers. Medical devices are regulated under the Health…
Regulatory authority After its independence in 1947, the Pakistan Government adopted India’s Drugs and Cosmetics Act, 1940. However, owing to the Act’s limitations, the Government of Pakistan enacted a completely new Drugs Act in 1976, which was administered by the Drug…
