Europe
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity...
EU MDR/IVDR
The institution responsible for medical device and pharmaceutical regulations in the United Kingdom is the Medicines and Healthcare products Regulatory Agency (MHRA). MHRA was formed in 2003 and its headquarters are located in London, England. In April 2013, MHRA...
Asia
The Turkish Ministry of Health (TMH) recently published a draft regulation to update its current, European Union-aligned Medical Device Regulation. While most of the requirements proposed in the draft regulation are identical to those stated in the EU’s Medical Device...
Europe
In Belgium, the regulation of medical devices is carried out by the Federal Agencies for Medical and Health Products (FAMHP). Like the rest of the European Union member states, Belgium separates medical devices into four categories: Class I, Class IIa, Class IIb, and...
EU MDR/IVDR
The Medical Products Agency (MPA), or Läkemedelsverket (Swedish), is a government body within the Swedish Ministry of Health and Social Affairs. MPA is primarily responsible for regulating medical device, pharmaceuticals, and cosmetics and ensuring that both patients...
EU MDR/IVDR
The institution responsible for medical device regulations in Spain is Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a state agency within the Spanish Ministry of Health, Social Services and Equality. Spain, just like all the other members of the...
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