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This certification verifies that a device meets all regulatory requirements for IVDs, which will soon change under the new in vitro diagnostic regulation (IVDR 2017/746).
Our Bangladesh regulatory process chart offer intuitive, high-level overviews of your path to product registration.
All companies planning to sell a medical device or IVD in the United States need to register their product with the US FDA.
Selling a medical device in Japan requires manufacturers to comply with the Japanese pharmaceutical and medical device act (PMD Act) and its corresponding registration process.
To obtain access to the Australian market, medical device and IVD manufacturers will need to include their product in the Australian Register of Therapeutic Goods (ARTG).
All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.
A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device.
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices under the new Medical Devices Regulation
Prior to being sold in the Kingdom of Saudi Arabia (KSA), medical devices must receive marketing authorization from the Saudi Food and Drug Authority (SFDA)
Foreign manufacturers entering the Malaysian market will be able to leverage their existing approvals in recognized reference markets
In Singapore, medical devices are overseen by the Health Sciences Authority (HSA). Classification of devices is similar to the system in Europe, but there are some differences.
This certification verifies that a device meets all regulatory requirements of the medical devices directive (MDD), In vitro diagnostic device directive (IVDD) or active implantable medical device directive (AIMD) as they apply to your product.
The first major revision to device regulations since 2007 has been released and the changes are significant. Smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute.
Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health.
Medical device and IVD manufacturers that want to sell their products in South Korea will have to follow the requirements of the Medical Devices Act
To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator.
In this free webinar, you’ll gain insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF study that should be acceptable to all stakeholders.
Medical devices in Hong Kong are regulated by the Medical Device Control Office (MDCO).
In Mexico, medical devices and In-Vitro Diagnostic (IVD) devices are governed by COFEPRIS, a division within the Mexican Ministry of Health (Secretaría de Salud).
The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including in-country representation requirements for companies selling their devices in Great Britain.