Combination products, which are innovative therapeutic and diagnostic products that combine drugs, devices, and/or biological products, are becoming increasingly prevalent in the healthcare industry. In China, the registration of these products is governed by specific Regulatory frameworks that help ensure their safety, efficacy, and quality.
The combination product market continues to grow as pharmaceutical, medtech, biotech, and life science companies keep innovating. Combination devices and drug products can provide more targeted treatment, enable better drug delivery, and improve the efficacy of both medical devices and drugs. The definition of combination products and their governing regulations varies between countries.
As we all know, there are continuous updates to the existing technologies alongside the advent of new ones. Incorporating these technologies into the drug-device combination products for tracking and monitoring purposes is increasing day by day. Given the continuous technological developments and wide range of medical devices or device parts that may be used with a medicinal product, it is essential to have appropriate guidelines on what type of information should be provided in a combination product’s Regulatory submission.
