Matrix has been deeply engaged in the legal service field of bio-medicine and medical devices for many years, specializing in creating a legal support system that is both professional and systematic for medical device and pharmaceutical enterprises. The majority of the team’s core members boast professional backgrounds in the biomedical or medical device sectors. Notably, several of our legal practitioners have accrued rich experience serving as in-house counsel for pharmaceutical and medical device enterprises, acting as consultants for regulatory authorities, or collaborating closely with scientific research institutions. Equipped with this unique blend of expertise, they possess an in-depth understanding of the legal pain points and regulatory rationale spanning the entire life cycle of these enterprises—from R&D, manufacturing, and product registration to commercialization.

We focus squarely on the core regulatory demands of medical device and pharmaceutical companies, conducting thorough analyses of the approval rules, inspection protocols, and policy orientations formulated by regulatory authorities including the NMPA and CDE for drugs and medical devices. Our services comprehensively and accurately cover compliance points in every critical link: medical device product design, clinical verification, registration declaration, production system assessment, and post-marketing adverse event handling. By doing so, we help enterprises establish a end-to-end compliance defense system and proactively avoid potential regulatory risks.

Legal services include but are not limited to:

·  Biomedical patent application, layout, invalidation, infringement litigation, and administrative protection

·  Legal services for the protection of technical secrets, trade secrets, and anti-unfair competition

·  Drafting and reviewing cooperative research and development contracts, technology transfer/licensing contracts

·  Legal services for drug/medical device registration and approval, and response to registration inspections

·  Legal services for drug/medical device pricing, bidding, and procurement compliance

·  Litigation involving drug/medical device infringement, arbitration and litigation of contract disputes

·  Full legal services for enterprises' domestic and overseas IPOs (STAR Market, Hong Kong Stock Exchange, US Stock Exchange, etc.)