KLN Medical’s Regulatory Affairs and Quality Assurance (RAQA) team, comprising licensed pharmacists and seasoned quality professionals, provides expert support for medical device and pharmaceutical regulatory compliance across Hong Kong and Macau.
We support clients in navigating complex local regulations, ensuring smooth and timely product registration, lifecycle management, and adherence to evolving compliance requirements.
Our Services Include:
Coordination and facilitation of medical device and pharmaceutical product registrations with relevant government authorities.
Acting as the Marketing Authorization Holder (MAH) for pharmaceutical products and the Local Responsible Person (LRP) for medical devices.
Ongoing oversight of product compliance across its entire commercial lifecycle, from initial registration to post-market surveillance.
Management of complaint investigations, clinical evaluation documentation, and regulatory communications with local authorities.
Close coordination with global and Mainland China partners to ensure cross-border regulatory alignment and efficiency in registration processes.
Bilingual support (Mandarin & English) for document translation and communication, ensuring clarity and accuracy in regulatory submissions.
Commitment to Quality and Compliance
Our RAQA team works closely with clients to prioritize projects, define clear timelines, and tailor compliance strategies that meet their business goals. We strictly adhere to Good Distribution Practice (GDP) and ISO 13485 quality standards, underpinned by robust internal training programs and comprehensive Standard Operating Procedures (SOPs).
At KLN Medical, we are committed to delivering operational excellence in regulatory affairs—ensuring our clients remain confident, compliant, and competitive in the local market.
