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...
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,...
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...
Asia
The National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), is the institution responsible for pharmaceuticals and medical devices regulations in China. Similarly to the FDA in the United States, the NMPA classifies...
Asia
Saudi Arabia’s Food and Drug Authority has published its final guidance on the new Medical Device National Registry (MDNR), a streamlined market authorization pathway for low-risk medical devices. This new market route is specifically for Class I non-sterile and...
Asia
For the last 70 years, only a handful of medical devices have been regulated in Pakistan under its Drug Act of 1976. In an attempt to control the quality of the devices being sold and used in the country, the Drug Regulatory Authority passed the Medical Device Rules...
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