Huge Market for Ortho-K Lens in China

Monthly NMPA News Roundup (March 2019)
April 10, 2019
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April 19, 2019

Huge Market for Ortho-K Lens in China

The International Congress of Ophthalmology and Optometry China (COOC) 2019 was held on March 22-24, 2019 in Shanghai, China. Myopia Management White Paper (2019) was released as well. COOC was focused on new products and discussed innovative treatments in clinical ophthalmology, optometry and vision science.

A number of Chinese and US KOL’s presented both novel research ideas and product updates. Some of the noteworthy talks included Presbyopia and Glaucoma from Dr. Paul Kauffman and CRT Safety Review from Dr. Mark Bullimore. The overall tone of the meeting was centered on myopia control a disease that the Chinese government is actively seeking to treat. Ministry of Education and other eight ministries of China published the Comprehensive Management Program for Myopia in Children and Teenagers last August. Chinese government is paying close attention to myopia management due to the high prevalence of the disease.

ChinaMedDevice, LLC has proven records in managing clinical trials for many ophthalmic products. We have long-term partnership with some clinical trial sites, including renowned TongRen Hospital in Beijing.

We have completed 23 ophthalmology products registrations from Class III to Class I. Some are first time approvals in their categories in China, such as perfluorodecalin solution and perfluorooctane solution for ophthalmic surgery. For more info, please contact info@ChinaMedDevice.com.

Myopia Management White Paper (2019) includes five sections:

  • Definition of myopia management
  • Establishment of refractive files
  • Myopia screening and prevention
  • Correction of non-progressive myopia with:

a. Glasses

b. Soft contact lens

c. RGP Contact Lenses

d. Refractive surgery

  • Intervention of progressive myopia with:

a. Ortho-K

b. Specially designed frame glasses, such as progressive multi-focal glasses, bifocals etc.)

c. Myopia control spectacle lenses

d. Multi-focal contact lens

e. Atropine

 

Several Ortho-K manufacturers have been on the market in China, such as Paragon, Lucid, Euclid, ProCornea, etc. In addition, there are number of larger lens companies such as Bausch+Lomb and Cooper vision who are focusing on specialty lenses as well as lens care products for the China market.  ChinaMed expects increased growth in segment of the market thru the end of the decade.

Clinical Trial Guideline for Orthokeratology Rigid Gas Permeable Contact Lenses (No. 51, 2018) was published by NMPA (CFDA) last July.

 

For Myopia Management White Paper (2019) and Clinical Trial Guideline for Orthokeratology Rigid Gas Permeable Contact Lenses, please email info@ChinaMedDevice.com.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.