CE marking is mandatory for all devices that are to be sold in the European Union (EU) countries. Similarly, In Vitro Diagnostic (IVD) devices must also obtain a CE marking and undergo a rigorous approval process to demonstrate their safety and efficacy. They have to abide by the requirements mentioned under the EU In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Each device has a specific set of requirements and procedures that they need to follow. In fact, the Regulatory requirements can be complex and challenging to follow.

With the implementation of the European Union (EU) Medical Device Regulation (MDR) 2017/745, one of the areas that caught the most attention was the new Post-Market Surveillance (PMS) system for devices. Establishing a PMS for a device has become a mandatory task for manufacturers. The objective behind this stringent requirement is to ensure device safety throughout the product’s lifecycle. Post-market Clinical Follow-up (PMCF) is part of the PMS and refers to the evaluation and collection of data for the devices placed in the market.

With the implementation of the European Union (EU) In Vitro Diagnostic Devices Regulations (IVDR) 2017/746, the Performance Evaluation Report (PER) has changed dynamically in terms of its requirements and approach.

The driving factors behind the medical device industry are still evolving, as the Gulf Cooperation Council (GCC)’s healthcare expenditure is rising dramatically. To maintain this trajectory, The GCC has developed a portal called Taawon to facilitate the registration and approval of drugs and medical devices in GCC countries.

The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.

The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).

510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (predicate). Devices with moderate risk are required to submit a 510(k) notification, which includes a minority of Class I and III devices and a majority of Class II devices.

The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.

With the enactment of NMPA’s Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device registration process.

Brazil is the largest economy in Latin America and the most promising medical device market. Medical device market in Brazil is governed by the Brazilian Health Regulatory Agency, ANVISA. The ANVISA came up with a new resolution, RDC 687/2022, for granting or renewing the Brazilian Good Manufacturing Practice (BGMP) certification for medical devices and is in effect from June 01, 2022, annulling RDC 183/2017.