Access The Global Market

Where would you like to market
your medical technology?

GMRE is here to assist with the registration of your medical devices in global markets and to secure their approvals and certifications, anticipating all potential issues in the process.

European Union

Medical products require CE marking before they can be marketed in the EU. CE marking proves that your product has been assessed and meets EU safety, health and environmental protection requirements. It is valid for products manufactured both inside and outside the EU, that are then marketed inside the EU.

Europe is undergoing a wide update of its regulations for medical devices, with the recently enforced MDR coming to replace the old AIMDD/MDD

USA

Manufacturers that are involved in the production and distribution of medical devices in the USA are required to register annually with the FDA. The Center for Devices and Radiological Health (CDRH) is the FDA center responsible for overseeing the medical device program.

Recently, FDA has been going through a digitalisation process, with the recent evolvement being the eSTAR submission program.

Latin America

Brazil, Argentina & Colombia

The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) is an autonomous regulatory body linked to the Ministry of Health, part of the Brazilian National Health System. Manufacturers exporting medical products to Brazil will have to be certified by ANVISA, a process which might include inspections at the place of origin.
The Argentinean National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – ANMAT) is the medical device market regulator within Argentina, assuring the quality of medical, cosmetic and drug products within the country. Requirements vary depending on the product.
In Colombia, the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA) is the regulatory agency responsible for regulating registration of medical products and devices. INVIMA is in charge of supervising and evaluating procedures of medical manufacturers and providing approval for the import and export of healthcare products within Colombia.

China

Although China’s medical regulatory bodies are coordinating more and more with international standards, the Chinese medical device approval process still poses significant difficulties for Western medical technology companies.
The China Food & Drug Administration (CFDA) is responsible for regulating medical devices, drugs, and healthcare services in China. The organization is headquartered in Beijing, with offices in each province.
Pharmaceutical and medical device manufacturers intending to market products in the Chinese market – one of the most rapidly growing in Asia – will need to obtain regulatory approvals from the CFDA according to the Chinese regulations, and re-certify once every 5 years.

Israel

The Israeli medical device market is one of the largest in the Middle East. Marketing your medical device in Israel requires registration with AMAR – the Medical Device Division in the Israeli Ministry of Health. This regulatory body is in charge with registering medical devices, granting various import permits for medical devices, and monitoring the marketing of medical devices in Israel.
AMAR registration requires prior approval for your medical device in one of the Global Harmonization Task Force (GHTF) founding countries, such as the United States, Canada, Europe, Australia or Japan. For manufacturers having already obtained approval for their devices in one of these markets (particularly in Europe and the US), registration will be almost automatic.

australia

In Australia, TGA (Therapeutic Goods Administration) submissions are essential for obtaining approval to market and sell therapeutic goods, including pharmaceuticals and medical devices. These submissions require comprehensive documentation and data to demonstrate product safety, quality, and efficacy. TGA reviews the submissions to ensure compliance with Australian regulations. Approval is necessary for products to be legally marketed and distributed in the Australian healthcare market.

Thailand

In Thailand, TFDA (Thai Food and Drug Administration) submissions are a critical part of gaining approval to market and distribute healthcare products, including pharmaceuticals and medical devices. These submissions involve providing detailed information and documentation to demonstrate product safety, quality, and efficacy. TFDA reviews the submissions to ensure compliance with Thai regulations, and approval is essential for access to the Thai healthcare market.

Canada

In Canada, Medical Device License (MDL) submissions are for individual medical devices, while Medical Device Establishment License (MDEL) submissions are for companies involved in device distribution. MDL authorizes device sales, and MDEL authorizes business operations in the Canadian medical device market. Compliance is vital for patient safety and market access.

Mexico

In Mexico, COFEPRIS (Federal Commission for the Protection against Sanitary Risk) submissions are a crucial step for gaining approval to market and sell health products, including pharmaceuticals and medical devices. These submissions involve providing detailed information and documentation to demonstrate the safety, quality, and efficacy of the products. COFEPRIS reviews the submissions to ensure compliance with Mexican regulations, and approval is necessary for access to the Mexican healthcare market.

GMRE

Global Medical Regulation Experts

GMRE was created to guide and support MedTech startups and established companies in introducing and keeping their medical products in the global market in the most efficient way.
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