The National Health Surveillance Agency of Brazil (ANVISA) published a resolution RDC no. 657 on March 30, 2022, regulating Software as a Medical Device (SaMD). The resolution has been effective since July 1, 2022.
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.
Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.
The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practitioners in decision-making for better patient care. South Korea’s Ministry of Food and Drug Safety (MFDS) has guidelines to regulate and monitor the use of AI and Big Data based medical devices.
The FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022. This list of guidance documents conveys a degree of transparency (in terms of where the regulator plans to commit resources and potentially increase scrutiny over the coming year and how manufacturers may be impacted in terms of compliance) for the medical device applicants and registrants who are willing to enter the USA market.
The FDA CDRH has divided its list of guidance documents into three (03) sections:
Over the past few decades, the use of software has drastically advanced and brought about rapid changes in the medical device industry. The increasing importance of software in medical devices and the patient’s experience is crucial for further developments. However, SaMD has challenges for both regulators and the medical device industries alongside the new opportunities.
Software and Artificial Intelligence (AI) play an important role in the medical device sector, with a fast-developing and wide set of applications in the health care system. Most of the applications will be regulated as medical devices and can range from screening to diagnosis to treatment and management of chronic conditions. However, alongside the rapid developments, Regulatory Agencies update the measures to further protect patient safety and ensure device efficiency.
With the evolution of technology, the healthcare industry has become keen on integrating software with medical devices to incorporate automation and accuracy in the prediction, diagnosis, prevention, treatment, and management of health conditions. The US FDA had long recognized the role software can play to benefit the functioning of medical devices but was yet to come up with any concrete guidance or rules that could have facilitated the industry researchers in making advancements towards digital health.
The application of software technologies in varied healthcare management, including diagnosis or treatment of a disease condition, is accelerating at an unprecedented rate. The global medical device Authorities are revamping their regulations and guidelines to address these booming device technologies. In Australia, Therapeutic Goods Administration (TGA) is the Regulatory Authority responsible for the oversight of medical devices, including software and mobile applications.
It is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition. This new regulation requires manufacturers to demonstrate appropriate levels of clinical evidence to gather the right clinical data based on the class of the IVD, intended purpose, the software involved and whether the software is independent or combined or an accessory?
