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...
Asia
The majority of medical devices sold in Japan are paid for by the Japanese National Health Insurance (NHI) system via reimbursement, which is oftentimes an even more critical matter than regulatory compliance. In order to market their products in the country,...
RegDesk News/Info
Oftentimes, medical device manufacturers spend so much time attempting to comply with the complex regulations of their target markets that they fail to direct enough attention toward picking the right distributor for their product. Once a distributor is chosen,...
Asia
In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labor, and Welfare (MHLW). The PMDA is an independent agency that works together with the MHLW to assess the safety and...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
