Cincinnati, Ohio – Guangzhou, China January 16, 2019: In 2018, the Chinese State Council announced their decision to suspend the implementation of the article 11, paragraph 2 of “The Supervision and Administration of Medical Device Regulation” in the special area known as the Hainan Boao Lecheng International Medical Tourism Pilot Zone for those devices with urgent need and without equivalent device within China. Accordingly, it will be up to the local Hainan Government instead of the central CFDA to approve the medical technologies to be used within designated healthcare institutions. This policy is intended to attract western medical device manufacturers, investors, and medical tourists into Hainan an island off of the southern coast of China known as the ‘Hawaii of China’. This will speed up the product approval to make sure patients can receive the most advanced treatment available in the world. The application process only takes seven days.
There are conditions including the requirement to work directly with one of the medical institutions in Hainan where there is an urgent need for these medical technologies, and there is not an equivalent solution in their market and the technologies with certain requirements to be met by an equivalent CFDA agency in the country of origin.
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