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Eyebright Medical receives Class III Certificate from National Medical Products Administration in China for its phakic intraocular lens
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Key Takeaways
- Eyebright Medical's Loong Crystal PR IOL received Class III certification from China's NMPA, indicating high regulatory approval for medical devices.
- The NMPA, part of the State Administration of Market Regulation, manages drug and medical device oversight, including registration and inspections.
The Loong Crystal PR IOL is designed for the treatment of myopia in adults ranging from -3.25D to -18.00D.
(Image Credit: AdobeStock/Mohammed)
Eyebright Medical Technology has announced that its phakic intraocular lens (IOL), the Loong Crystal PR, has received Class III Medical Devices Certificate from the National Medical Products Administration (NMPA).1
The NMPA oversees drug and medical devices in China and reports to the State Administration of Market Regulation (SAMR). The NMPA is responsible for conducting drug registration and approvals, providing guidance to provincial authorities, and working with provincial-level investigators to assign inspections of clinical trial facilities and international inspections.2
The Loong Crystal PR IOL is designed for the treatment of myopia in adults ranging from -3.25D to -18.00D.
According to the company, the Loong Crystal PR IOL is constructed from an “advanced balanced acrylic material” and incorporates a “zero spherical aberration design with a large optical zone and a double concave stable arch height structure.” Furthermore, the company states that this design “not only boosts optical performance but also elevates the overall visual experience, meeting the high expectations of patients for visual clarity.”
Eyebright Medical is an ophthalmic medical device manufacturer for cataract surgery, myopia management, and consumer vision care located in Beijing, China.
References:
Eyebright Medical receives NMPA class III certificate for its phakic intraocular lens. January 7, 2025. Accessed January 7, 2025. https://www.prnewswire.com/news-releases/eyebright-medical-receives-nmpa-class-iii-certificate-for-its-phakic-intraocular-lens-302344343.html
China Office, US Food and Drug Administration. Accessed January 7, 2025. https://www.fda.gov/about-fda/office-global-operations/china-office
