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Rare Disease Device Guideline: Imported Device Exempt from Clinical Trial If Meeting Certain Requirements


CFDA issued Registration Guideline on Medical Device for Rare Disease on October 18th, 2018 in an effort to address the huge unmet medical needs. The guideline lists three situations when clinical trial can be exempted:

  1. Preclinical research, such as literature review, animal test, modeling and simulation, proves that benefits overweigh risks.
  2. Comparison with equivalent marketed device, which proves safety and efficacy.
  3. Imported devices, with home country approval, meet the requirements for Accepting Overseas Clinical Data.

The guideline also states the Conditional Approvals will be used to accelerate the R&D of rare disease devices and IVDs. Devices and IVDs can be approved without enough clinical data, if manufacturers are committed to do further clinical research.

For CFDA link of the Registration Guideline on Medical Device for Rare Disease, please email

Communication with CFDA is hugely encouraged, says the Guideline. ChinaMedDevice is a CFDA certified legal agent. We can present you without your need to setup an office in China. For more information about legal representation, please email


China has the world’s largest population with rare diseases, numbering between 15M and 20M, according to the Financial Times article published in early 2018.

As China’s medical insurance is far from being mature, the families often have to pay all the cost out of pockets themselves. Huang Xifeng’s parents have paid Rmb 2.5 Million, roughly $360,000 USD for a bone-marrow transplant for their 17 years old son. The son has epidermolysis bullosa, a rare condition causing skin to blister and tear.

Chinese government rare diseases policies have given them hopes. On May 11th, 2018, the 1st Batch of Rare Diseases got published by the central government and 121 conditions have been officially recognized for the very first time.


Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.



About China Med Device, LLC

China Med Device, LLC (, a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.

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