Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking.

While the process for self-declaration seems easy compared to other device routes, the intricates, when ignored, can create complications in placing the device in the EU market. Below are some of the key points that manufacturers need to note while placing Class A devices on the market:

The need for continuous improvement in product quality, reliability, and safety arises due to recalls, updates of Regulatory requirements, and the desire to gain a competitive advantage. The newly introduced changes may alter the risk profile of the device, and the device manufacturers must revisit risk evaluations that pinpoint and reduce part or system failures over the product's lifecycle.

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.  

The medical device industry landscape is ever-changing owing to globalization and the advent of newer technologies. Due to these constant changes and developments, medical device organizations need robust change management systems.

A change can be prompted at various stages of the medical device life cycle. Some of the common events that can act as ‘triggers for changes include the following:

Mexico is one of the largest importers and a remarkable manufacturer of medical devices in the world and specifically gripping in Latin America. Mexico, offering an attractive market for foreign companies, is ministered by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), the Regulatory Body of the Mexican Government. In April 2022, COFEPRIS announced new rules for medical device submission.

Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures.

Medical device manufacturers must include required documentation with every product to help consumers understand its use. This documentation, sometimes, can have a few hundred pages, which is daunting for consumers. Quick reference guides are curated to cover all necessary product information, and the consumers may not have to wade through a ton of content to find it.

A quick reference guide provides a set of brief instructions for using a medical device and has its own set of advantages as follows:

The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.

Digital health technologies have become a focus for investors in the healthcare industry in China. The NMPA has set various laws and policies regulating digital health technologies. The NMPA considers digital devices such as healthcare apps, wearables, and Software as a Medical Device (SaMD) as medical devices under the Medical Device Regulation (Order #739). Manufacturers must follow the registration process accordingly.