Your Global Bridge in Medical Device Regulatory Affairs
Connecting western innovation with the Chinese medical market. We navigate NMPA compliance so you can focus on saving lives.
We help you make the right decisions early, so you can reduce risks, avoid rework, rejection, and lose time.
Our Expertise
Where Companies Struggle (and How We Solve It)
Companies rarely seek help for routine submissions. They come to us when timelines slip, requirements are unclear, or risks are underestimated.
Whitney Consulting focuses on identifying and resolving these risks early. Our end-to-end guidance for medical device and IVD registrations ensures seamless entry into the Chinese market with full compliance.
“Serving global medical device companies since 1994, with deep expertise in NMPA regulatory strategy and execution.”
Why Whitney Consulting
Your Trusted Partner Since 1994
We are the bridge between Western medical innovation and the Chinese regulatory landscape — with offices in Boston and Beijing and decades of proven results.
- Deep expertise in NMPA and MOH regulations since 1994
- Bilingual team bridging US and China regulatory requirements
- Full-service from clinical evaluation to post-market surveillance
- Proven track record with Class II and III high-risk devices
- Active member of RAPS, AACC, FIME, MEDICA and CMEF conferences
- Offices in Boston, MA and Chaoyang District, Beijing
“Yes! Great job everyone, this is fantastic news!! 🎉 Big thanks to you and your team, Chang-Hong, for your efforts and support! 2 major approvals in less than a year is such an amazing accomplishment.”
Regulatory Affairs
Capturing the Chinese market begins with NMPA product registration.
All medical products must be registered (i.e. approved) by Chinese regulatory authorities, such as National Medical Products Administration (NMPA). For international companies, entering the Chinese market is not simply a registration process, it is a series of high-risk and high-impact regulatory decisions that determine timeline, cost, and success.
Most delays and failures occur before submission, due to incorrect assumptions about classification, testing requirements, or clinical pathways.
NMPA Product Registration Strategy
A well-structured China NMPA registration strategy is fundamental to achieving efficient and successful market entry, as the process requires careful alignment of product classification, regulatory pathway selection, clinical evaluation approach, and technical documentation tailored to Chinese standards.
Post Market Surveillance
Compliance with NMPA post-market surveillance (PMS) requirements is essential to maintaining market authorization and ensuring the long-term safety and performance of medical devices in China.
Wireless Compliance
As wireless and radio transmission technologies become more common in everyday life, it is increasingly common to see products that can transmit patient data using WIFI, cellular networks, and Bluetooth technologies which requires additional approvals from the Chinese government that governs radio transmission and Network Access.
NMPA Mandatory Type Approval for Medical Measurement Instruments
In addition to medical device registrations, NMPA mandates that certain devices with measurement capabilities must undergo another approval process, called "Type Approval". This approval includes in-China testing to specific test standards and subsequent approval process. Besides the type approval, some of these products are also subject to periodical inspections (annually) by regional laboratories.
Clinical Affairs
Clinical Evaluation or Clinical Trial – that’s the question!
Clinical strategy in China is often misunderstood, and frequently over- or under-estimated, resulting in unnecessary cost or delay.
"Without data, you are just another person with an opinion"
We determine the least burdensome compliant pathway by evaluating:
- predicate device equivalence
- availability of clinical data
- exemption eligibility
When properly researched and justified:
- clinical trials can be avoided
- submission timelines can be significantly reduced
When trials are necessary, the key risk is poor design leading to regulatory rejection.
If a clinical trial is unavoidable, we support:
- protocol development aligned with NMPA expectations
- site selection and study management
- regulatory submission and approval processes
Our focus is ensuring that trials are accepted the first time.
Clinical Study
Professional Trial Management & Execution
Comprehensive trial management from protocol design to execution.
Clinical Evaluation
NMPA Compliance through Clinical Data
Expert evaluation using clinical data and literature for NMPA compliance.
Consulting
Accelerating Approvals. Reducing Risk. Delivering Results
Regulatory has become an important and integral part of any medical business. Inefficient regulatory management can result in not only loss of opportunities in the marketplace, but also potential risks for noncompliance. A well-designed regulatory strategy enables a company to manage its activities effectively and avoid potential pitfalls in the future.
Whitney Consulting has guided many companies over the years to better plan and execute their China regulatory practice by providing critical guidance on regulations, compliance, and post-market supervision and problem solving. Whitney Consulting is a full-service China regulatory consulting firm. We formulate strategies with clients from clinical evaluation and product registration to post-market monitoring and regulatory reporting. These strategies are framed to effect speedy approvals, to avert potential risks through early-decision making process.
Strategy Analysis and Formulation
A well-defined regulatory strategy is critical for successful entry into the Chinese medical device market, where requirements are complex, evolving, and strictly enforced.
China Legal Representative
Appointing a qualified China Legal Representative (also referred to as “the local agent”) is a mandatory and strategically critical requirement for international medical device manufacturers seeking to enter and operate in the Chinese market.
Chinese IFU & Chinese Label Management
Compliance of Chinese Instructions for Use (IFU) and product labeling with NMPA regulations is a critical component of both product registration and post-market compliance, as these materials serve as the primary interface between the manufacturer, healthcare professionals, and patients.
Customized Digital Solutions
China's healthcare ecosystem has moved digital. Your product documentation should too.
Quality Management System (QMS) for Manufacturers
Quality systems in China are not static; they are actively reviewed and enforced. We provide quality management system audits for medical device manufacturers in China.
We provide QMS audits focused on:
- ●identifying compliance gaps
- ●preparing for regulatory inspections
- ●aligning global systems with Chinese requirements
Our audits prioritize risk exposure, not just checklist compliance.
“If you think compliance is expensive, try non-compliance.”
QMS Auditing
Manufacturing, Distribution, Sourcing (material, components, finished products), Clean room and sterilization operations, Active devices, Non-active devices, Sterile single-use devices, Other specialized products.
Audit Principles
Our bilingual auditors can audit in China and the rest of the world, adhering to the principles of auditing: Integrity, Fair Presentation, Due Professional Care, Confidentiality, Independence, Evidence-Based Approach, and Risk-Based Approach.
Audit Criteria
ISO 13485:2016, Chinese Quality System Regulations on Manufacturing, Distribution, Post-market, Gap Analysis, and Surveillance / Maintenance Audits.
Resources
Who We Are
30+ Years History
Whitney Consulting has supported medical device companies entering China since 1994.
We are not a volume-based consulting firm. We are engaged when:
With teams in the U.S. and China, we bridge regulatory expectations with practical execution.
Industry Engagement
We actively contribute to global regulatory discussions, including:
Our insights are grounded in real regulatory experience, not theory.
Regulation Libraries
Regulatory Framework & Official Sources
Video Libraries
Expert Insights on Chinese Medical Device Regulations
Watch our collection of educational videos covering NMPA classifications, registration processes, and more.
Contact Us
Get in touch with our experts to discuss your NMPA regulatory needs.
Whitney Consulting Beijing Office
B602, Shitong International Mansion, Jianguo Road, Beijing 100024
Whitney Consulting US Headquarters
Whitney Consulting Ltd. PO Box 51177 Boston, MA 02205-1177
Get in touch with us directly via email. Our team is ready to discuss your NMPA regulatory needs.
info@whitneyconsulting.net