BradyKnows Medical
Your Go-To Partner in China

BradyKnows Medical is a medical device consulting firm that provides CRO services and facilitates the entire medical device lifecycle from, pre-market through post-market phases. With a focus on medical devices and in-vitro diagnostic products, the company serves as a major gateway to the Chinese market for global medical device manufacturers. Foreign firms often struggle to establish themselves in a completely new market. BradyKnows aids such clients by creating a comprehensive go-to-market strategy, guiding their commercial activities and enabling them to obtain regulatory registration with the Chinese authorities. During this process, BradyKnows advises if a clinical trial is required. It creates a clinical evaluation report (CER) based on previously available clinical data and optimizes clients’ resources.

“As a one-stop shop, we take care of all necessities during the entire life cycle of a medical device in China for our clients,” states Tracy Yu, General Manager at BradyKnows Medical. As a consulting firm, BradyKnows assists its clients with quality assurance (QA) and post-market surveillance (PMS). During the pre-market phase, the company ensures that its clients’ quality management systems (QMS) comply with the requirements declared by the Chinese authorities. A manufacturer outside China may abide by the FDA or the EU requirements, so BradyKnows performs a gap analysis to accurately determine the documents the client should provide to the National Medical Products Administration (NMPA) and verifies that their QMS complies. During the post-market phase, BradyKnows further helps its clients to stay compliant with those requirements by performing adverse events reporting or annual safety reporting called the periodic risk evaluation report (PRER).

Over the years, BradyKnows has gained significant expertise handling overseas manufacturers and stays a cut above the local Chinese CRO firms. The company has established offices in the US and employs bilingual project managers and consultants who bring differentiation to its service through better communication with overseas clients. It assigns a separate manager for each project and aids the clients from beginning to the end with RA/QA, CRO, and legal representation in China.

For instance, a US-based manufacturer aimed to launch a high-risk, class three cochlear implant in China. The Chinese government had published guidelines to inform manufacturers if a specific product needed to undergo a clinical trial or evaluation. The recommended clinical pathway was to perform a clinical trial in China, however, BradyKnows helped the client to obtain market approval by writing a CER, saving them a lot of time and money.

In the Hainan province in China, a special policy allowed import of unapproved products. Because this advanced cutting-edge product was intended for emergency clinical use, BradyKnows’ team enabled the client to apply for the urgent use program and shipped those implants to the pilot tourism zone in the Hainan province. Locals and many Chinese nationals traveled to Hainan province for treatment, and BradyKnows collected real-world data from those patients, primarily children, and submitted the report to the authorities to obtain final market approval. If a patient traveled to the US for the same treatment, the expenses would have been seven times higher.

BradyKnows has solidified its position as a specialist in medical device consulting by bringing a myriad of innovative products to China in minimal timeframes while formulating smart strategies for clients which include regulatory, clinical, and commercial goals.