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Grace Fu Palma
Principal @China Med Device
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WORK HISTORY
Principal @China Med Device
Boston, MA, US
25+ years at MedTech industry with multinational corporations, start-ups and finally founding China Med Device with offices in Boston, Beijing and Hainan. We offer overseas manufacturers both a local point of contact and China-based technical expertise to accelerate overseas MedTech companies entry and growth into China. ChinaMed Device, LLC provides regulatory, clinical and commercial turnkey solutions for medical device, IVD, CDx and combination product. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation report, full service CRO, QMS, post-market compliance and overseas inspection. Our commercialization services include: market research, reimbursement, partnership, and distribution qualification. We are a NMPA (CFDA) qualified legal agent and will be able to represent you without your needing to set up office in China. In addition, we are a designated Hainan China market access advisory firm for China UNAPPROVED devices to launch and conduct real world data study. Being the founder of Chinese American Heart Association a non-profit 500 member society with clinicians of Chinese origin in cardiovascular care and research in 2005, I have established deeper knowledge and network of cardiovascular field.
EDUCATION
Peking University
BA, International Relations
Yale School of Management
MBA, business
SKILLS
ABOUT GRACE FU PALMA
China Med Device, LLC as part of the Accel Groups global platform, offers manufacturers both a local point of contact and China-based technical and clinical expertise to accelerate MedTech companies entry and growth into China and out of China to other key geographic regions. With offices in Beijing, Hainan and Boston, we provide one-stop services for in regulatory, clinical evaluations/trials and commercial areas for medical device, IVD, CDx and combination product. Our regulatory services include: regulatory strategy, RA, clinical evaluation report, full service CRO, QMS, post-market compliance and on-site audits. Our commercialization services include: market research, reimbursement, partnership, and distribution qualification. We provide key country manufacturer representative services so that you do not need to set up directly local offices. In China, we are the pioneer advisory firm for Hainan Boao and Great Bay Area (GBA) special approval policies for UNAPPROVED devices to launch in months and conduct real world data study.
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