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Two Invoice Policy Will Reshape China Distribution Landscape (2)


Two Invoice Policy in China Brings Great Opportunities for The Integration of Medical Device Industry

At the end of January 2018, the “Two Invoice Policy” has been implemented in 24 provinces across the country, and the remaining seven provinces are in transition. It is expected that by the end of 2018, 31 provinces will fully implement the “Two Invoice Policy”.

With the full implementation of the “Two Invoice Policy” in the pharmaceutical industry, it is foreseeable that the implementation in the medical device industry will gradually begin. Due to the wide variety of medical devices, the distribution model of different products is more complicated. It is expected that the implementation in the medical device industry may take longer than the pharmaceutical industry. We expect the “Two Invoice Policy” to begin with high-value consumables, followed by in vitro diagnostics (IVD) and then low-value consumables.

Under the “Two Invoice Policy”, large medical device dealers with different business coverage in different regions began to seek acquisition of other agents to expand their regional and hospital customer coverage. The development of smaller circulation companies will be limited. The entire medical device industry will enter the integration phase of mergers and acquisitions. Up to now, more than 10 provinces and municipalities have clearly issued a document indicating that medical consumables and diagnostic reagents (IVD) have clearly implemented a “Two Invoice Policy”, strictly limiting the number of distributors.


China Med Device can help you with distribution qualification and management in China. For any inquiries, please email

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About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling Innovation Approval and Priority Review. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.

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