Individual countries are responsible for determining the safety and efficacy of medical devices marketed in their own country. This task is usually assigned to a government organization within the country’s healthcare system. Although each country has its own individual standards for medical device approval, they tend to employ a similar risk stratification assignment model when assessing safety. For example, a bandage would be assigned to a lower risk class than an implantable device.

To facilitate the distribution of necessary medical devices across international markets, attempts have been made to standardize the approval procedure through the implementation of international standards. The International Medical Device Regulators Forum (IMDRF) was established by the World Health Organization and representatives from Australia, Brazil, Canada, China, the European Union, Japan, and the United States. The purpose of the IMDRF is to accelerate the international harmonization of medical device regulations. Below is helpful information and links to various international medical device regulatory agencies and companies that can assist in navigating the regulatory agencies.

International

Africa. Africa is highly dependent upon importing medical devices. No African countries have specific institutions dedicated to the regulation of medical devices, but rather incorporate the oversight of such devices into their overall healthcare agencies.

  • Algeria. Algeria uses a categorization system similar to the EU. The regulation of medical devices is under the control of the Directorate of Pharmacy in collaboration with the National Laboratory for the Control of Pharmaceutical Products, which are supervised by the Ministry of Health and Population, Hospital Reform. Algeria requires the use of an appointed representative to submit all documentation to the Directorate of Pharmacy.
  • Egypt. Central Administration of Pharmaceutical Affairs (CAPA), a division of the Ministry of Health, oversees the regulation of medical devices.
  • Ethiopia. Medical devices in Ethiopia are regulated by the Food, Medicine, and Health Care Administration and Control Authority (FMHCACA). Similar to the FDA, the FMHCACA has three levels of classification for medical devices. Ethiopia requires an authorized representative to submit all documentation.
  • Kenya. All medical devices are regulated by the Drug Policy and Planning Center (DPPC) and the Central Administration of Pharmaceutical Affairs (CAPA). Kenya uses a four-level risk assessment.
  • Nigeria. All medical devices are regulated by the National Agency for Food and Drug Administration and Control (NAFDAC). Nigeria has four categories of risk for device assessment. Nigeria requires an authorized representative to submit all necessary documentation.
  • South Africa. In 2017, the South African Health Products Regulatory Authority (SAHPRA) was established to regulate the manufacturing and distribution of medical devices into the country. South Africa uses a four-tiered classification for risk assessment. South Africa requires an authorized representative to submit all necessary documentation.

Australia. The Australian Regulatory Guidelines for Medical Devices (ARGMD) provides guidance for the import and export of medical devices into and out of Australia. In addition, the ARGMD explains the requirements governing medical devices in Australia.

Canada. The Medical Device Bureau of the Therapeutic Products Directorate (TPD) is responsible for overseeing the safety and efficacy of therapeutic and diagnostic medical devices in Canada.

China. The National Medical Products Administration (NMPA) is responsible for medical device regulation in China. Like the United States, China has three classes of medical devices.

Europe. The European market comprises the 27 member countries of the European Union along with Iceland, Norway, and Liechtenstein. According to the European guidelines, there are four classes of medical devices: I, IIa, IIb, and III. Class III devices hold the highest risk. In May 2021, the Medical Device Regulations (MDR) will replace the Medical Device Directive (MDD). The MDR will require that all companies selling their devices in the European Union member countries comply with the new regulations. The new regulations can be found here. Medical devices in compliance with the MDR will receive a “CE” marking.

India. The Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare is responsible for the regulation of drugs, medical devices, diagnostic devices, and cosmetics. Currently, India is widening its list of regulated medical devices, and virtually all devices will be regulated by April 2021.

Israel. Israel’s Department of Fighting Crime in the Field of Medical Devices (AMAR) is responsible for regulating medical devices for Israel’s Ministry of Health. Israel’s regulators require prior approval from Global Harmonization Task Force (GHTF) countries, such as FDA 510(k) or premarket approval letter, CE marking notification from an EU country, a Certificate to Foreign Government (CFG)/Certificate of Free Sale (CFS), or proof of ISO 13485 certification. To register a medical device in Israel, the manufacturer must have an authorized representative in the country.

Japan. Pharmaceuticals and medical devices are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). The MHLW is responsible for registering manufacturers, overseeing the PMDA, licensing of various actors (e.g., dealers and service providers), enacting ministerial ordinances, and the final release of medical device authorizations. The PMDA performs inspections of manufacturers for Good Manufacturing Practice (GMP) compliance, performs market surveillance, provides advice for clinical studies, and conducts regulatory reviews.

Latin America. Argentina, Brazil, Paraguay, and Uruguay are members of MERCOSUR (Mercado Común del Sur, or Common Market of the South), which is a free-trade agreement currently in place among the countries. Bolivia and Chile are associate members. With respect to medical device usage, MERCOSUR has regulatory guidelines in compliance with those of the EU. However, each member country can alter these guidelines. The links and information below highlight some of the regulatory items for individual Latin American countries. One caveat to entering the Latin American market is that most applications are required to be filled out in Spanish, so language fluency and knowledge of the regulatory agencies is vital.

  • Argentina: Medical devices are regulated by the National Administration of Drugs, Foodstuffs, and Medical Technology (ANMAT). To register a device, a company must have an importer in Argentina that is registered with the Ministry of Health.
  • Brazil: Medical devices are regulated by the National Health Surveillance Agency (ANVISA). To register a medical device in Brazil, the manufacturer must have a local distributor in the country that is registered with Brazilian Health Services.
  • Chile: Medical devices are regulated by the Public Health Institute (ISP). With the exception of some low-risk devices (syringes, gloves, and syringes), regulatory registration is voluntary.
  • Colombia: Medical devices are regulated by the National Food and Drug Surveillance Institute (INVIMA). To register a medical device in Colombia, the manufacturer must have a legally recognized representative in the country.
  • Mexico: Medical devices are regulated by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). To register a medical device in Mexico, the manufacturer must have a legally recognized representative in the country.

United Kingdom. The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating all medical devices within the UK. With the exception of Northern Ireland, all medical devices sold in the UK will require a UK Conformity Assessed (UKCA) mark. Northern Ireland will maintain a separate regulatory pathway that is more aligned with that of the European Union. If the device is not manufactured in the UK, then a registered representative must be appointed.

Sources: Johner Institute Japan  |   Emergo by UL