Clinical trials form a critical phase in the development and approval of medical devices. They provide the necessary evidence to demonstrate the safety and efficacy of a device before it can be marketed. The United States Food and Drug Administration (US FDA) sets stringent requirements for conducting clinical trials to ensure that the data collected are reliable and that patient rights are protected.

Digital therapeutics, also known as software-based therapies, have gained significant attention as an alternative treatment option for various chronic diseases. With improved patient outcomes, real-time monitoring, greater accessibility and flexibility as well as cost-effectiveness, digital therapeutics has revolutionized the healthcare sector, and worldwide health agencies are currently focusing on regulating this class of devices effectively.

China is a major player in the medical device industry, and with its diverse population and expanding healthcare market, companies need to understand the necessary clinical trial requirements for medical device products in this region. The Chinese government has implemented a variety of regulations to ensure the safety and efficacy of medical devices being placed on the market.

You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021. These provisions are designed to offset the negative consequences in the absence of an MRA (Mutual Recognition Agreement) update and to ensure a sufficient supply of medical devices to Switzerland. Let us know more about these amendments.

Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc. But unless the Regulatory constraints are eliminated, the AI will fall short of reaching its full potential in Life Sciences.

National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018. The guidelines will come into effect in 2019 (exact timeline is yet to be declared by NMPA), after which all the new/existing devices applying for registration/renewal will have to comply with them.