China Med Device (CMD) provides the regulatory, CRO and market intelligence to help companies access China’s fast-growing $80-billion medtech market. CMD has partnered to create over 1,200 success stories for manufacturers of medical devices, IVDs, combination products and more.
U.S. and European companies can be frustrated by China’s National Medical Products Administration (NMPA), a regulatory system that differs greatly from FDA, EU and other international markets. CMD focuses solely on China, so we can help companies overcome regulatory hurdles as well as significant language and cultural and differences that can impact your business.
Our team has decades of clinical/technical experience, previously working for medtech companies or in auditing roles with regulatory agencies. This deeper understanding of medical device development and how NMPA applies requirements in real life allows CMD to deliver clear guidance and practical solutions.
CMD has offices in both Boston and Beijing to give our clients quick access to a local, bilingual and bicultural team. Count on CMD as your partner throughout the complete product life cycle. Here are our key services and areas of expertise:
Regulatory
• Registration, renewal and modification
• Quality Management System (QMS)
• Postmarket surveillance / Local Agent representation
Clinical Research Organization (CRO)
• Clinical trial management / CER
• Overseas clinical data acceptance
• Real World Data / Evidence (RWD/E)
Business
• China market assessment and due diligence
• Reimbursement analysis
Device Types
• Class I – III, active/passive, implants software/SaMD, combination products
• IVD/Diagnostics: reagents, CDx, systems, test kits, assays
• Clinical indications: orthopedics, ophthalmology, cardiovascular, IVF, oncology, radiology, imaging
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Company Details
- Employees
- 12
- Founded
- -
- Address
- 800 Turnpike St.,
- Phone
- 978-390-4453
- in****@****ice.com
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- chinameddevice.com
- Keywords
- Post Market Surveillance, China Market Assessment, Competitive Intelligence, China NMPA Regulatory Service, Clinical Trial, Clinical Evaluation Report, In-country Representation, Adverse Event Reporting and Monitoring, Quality Management System, On-site Local Testing Support.
- HQ
- North Andover, MA
China Med Device Questions
China Med Device's helpline number is 978-390-4453
China Med Device's website is chinameddevice.com
China Med Device's LinkedIn profile is https://www.linkedin.com/company/china-med-device
China Med Device has
12 employees.
View email and phone details for 12
employees at China Med Device.
China Med Device's industry is
Medical Equipment Manufacturing
China Med Device's top competitors are
Antylia Scientific,
Medtronic,
Momenta Pharmaceuticals,
Owens & Minor,
Zoll Medical Corporation,
Pepgen,
Breegi Scientific, Inc.,
Vantage Medtech,
Abbott,
Nova Biomedical.
China Med Device's support email address is info@chinameddevice.com
China Med Device's categories are Medical Equipment Manufacturing
China Med Device's founding year is 2011
