As technology continues to revolutionize the healthcare industry, software applications play an increasingly critical role in the medical device industry. In Japan, the regulations surrounding Software as a Medical Device (SaMD) are robust and are specifically designed to ensure patient safety and product efficacy.
In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO), is a temporary license that allows a manufacturer to conduct tests on their medical device before they can obtain a permanent license for it. The test license allows the manufacturer to conduct clinical trials and other tests on the device and gather data on its safety and efficacy. The CDSCO requires the manufacturer to obtain this license to ensure that the device is safe and effective for patients’ use.
The European Union's (EU) Medical Device Regulation (MDR) has been making news for a while now. The MDR has replaced the Medical Device Directive (MDD) and Active Implantable Device Directive (AIMDD). Initially, the entire transition was set out to be in complete effect by May 2020; however, due to the emergence of the COVID-19 pandemic, the implementation was pushed further to May 26, 2021. In this timeline, by May 26, 2024, all the MDD certificates will become void, and the device manufacturers will be required to conform with the EU MDR.
ANVISA comes up with a new resolution, RDC 751, effective from March 01, 2023. The Resolution defines the risk classification rules for medical devices, labeling requirements and Instructions For Use (IFU), and the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices. It revokes RDC no. 185/2001, RDC no.15/2014, and RDC no. 40/2015. Here is the gist of the latest Brazilian regulation.
A “predicate device” is a medical device that has been previously approved by the US Food and Drug Administration (US FDA) and is already on the market, which serves as a reference point for new medical devices seeking approval through the FDA’s 510(k) clearance pathway.
As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight. But, for the highest-risk Class III devices, the FDA uses the most stringent Regulatory control – the Premarket Approval Process.
It has been observed for long that innovation drives the life sciences industry, and this would continue perpetually. For the betterment of human health, there have been many innovative drugs/devices released into the market. For good, some of them shaped the humankind well, but alas some had to be taken off the market due to their adverse reactions and manufacturing and Regulatory procedural setbacks.
In a recent notification, the South Korean national health authority - Ministry of Food and Drug Safety (MFDS) announced that the Agency no longer requires the submission of full summary technical documentation (STED) files for the registration of high-risk (class IV) medical devices.
Do you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO). To increase the ambit of Regulatory supervision and ensure efficacy and safety of medical devices, in early 2017, the CDSCO drafted and published the Medical Device Rules – 2017, which were made mandatory from January 1, 2018.
