Introduce FDA or CE approved ophthalmic medical devices into Hainan pilot zone , register and expand in China.
Background
In 2018, the China National Medical Products Administration issued the Interim Provisions on the Management of Clinically Needed Imported Medical Devices in Hainan Boao Lecheng International Tourism Pioneer Area. It is clear that medical devices that have not been approved in China but have been listed abroad can be sold and used in Hainan Boao Lecheng International Tourism Pioneer District Hospitals through special approval procedures.
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Hainan (Boao) International Ophthalmology and Optometry Hospital is such a hospital. The hospital is preparing to introduce a number of the most advanced ophthalmology and optometry products. First three major areas include:
1. Artificial cornea.
2. Advanced intraocular lens.
3. Scleral lens.
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