2023 Ophthalmic Consumables Registration and Market Category Insight

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Ophthalmology registration approval status

  1.1 First registration approval status of imported/domestic Class III medical consumables

In 2023, a total of 266 imported Class III medical consumables were registered for the first time in China, which was basically the same as in 2022. Among them, the number of ophthalmic instruments in 2022 was 29, accounting for 10.98%, and the number in 2023 was 36, accounting for 13.53%. According to the analysis by year, the top three first registered medical consumables products in 2022 included ophthalmic instruments (10.98%), which wa still in the top three in 2023, accounting for 13.53% of the total; From trend analysis, the proportion of first registration of passive implantable devices has increased significantly in 2023, ranking first for two consecutive years, while the proportion of first registration of ophthalmic devices and passive surgical devices has slightly increased.

In 2023, a total of 1598 third class medical consumables were registered for the first time in China, a year-on-year increase of 9.75%. Among them, the number of ophthalmic instruments in 2022 was 49, accounting for 3.37%; The quantity in 2023 was 51, accounting for 3.19%.

1.1  Registration Status of Ophthalmic Instruments (Consumables)

Ophthalmic instruments refer to various types of ophthalmic instruments and related auxiliary equipment used for ophthalmic examination, surgery, treatment, and protection, excluding ophthalmic rehabilitation training equipment.

• Product quantity

According to publicly available data from the National Medical Products Administration, provincial (autonomous region, municipality) drug regulatory bureaus, and market supervision bureaus, as of the end of 2023, there were a total of 4600 registered and filed ophthalmic devices (consumables) products in China, including 3705 domestically produced products and 895 imported products.

From the analysis of the number of initial registrations, the number of initial registrations for ophthalmic instruments (consumables) in China has increased in 2023. In 2023, the total number of first registrations for Class II and III ophthalmic instruments (consumables) in China was 122, including 84 domestic products and 38 imported products.From the trend of changes in the first registration quantity of the second and third categories of products, the first registration quantity of imported third category products for ophthalmic instruments (consumables) has slightly increased, while the first registration quantity of imported second category products has decreased. The first registration quantity of domestically produced second and third category products was relatively stable. From the perspective of management categories, the proportion of first-time registrations for domestically produced Class III products was relatively high

• Product distribution  By the end of 2023, China has imported 895 ophthalmic devices (consumables), including 289, 176 and 81 products from the United States, Taiwan, China, and South Korea, accounting for 61.01% of the total.

• Product localization rate    In 2023, there were a total of 55 secondary categories of effective ophthalmic equipment (consumables) products in China, of which 47 had a localization rate of over 50.0%.

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Category situation of ophthalmic consumables market

As of the end of 2023, according to the data from the National Healthcare Security Information Business Coding Standard Database, a total of 1426 ophthalmic materials in China have entered the healthcare security consumables classification catalog, including 874 imported (including Hong Kong, Macao, and Taiwan) products and 552 domestically produced products. The classification catalog of healthcare security consumables in China – imported ophthalmic materials mainly came from the United States and Germany, with the sum of the two accounting for 58.0% of the total imported products.

China’s domestic ophthalmic materials products cover intraocular lenses, intraocular fillers, intraorbital fillers and glaucoma drainage implants and other high-end, potentially dangerous products to the human body, among which the domestic products entered the healthcare security consumables classification catalogue of other ophthalmic materials for 351, intraoperative materials for 108, intraocular lenses for 62.

The classification catalog of healthcare security consumables in China – Domestic ophthalmic materials products are mainly concentrated in Jiangsu Province, Tianjin City, and Beijing City, with a total of 161, 49, and 48 products respectively, accounting for 46.7% of the total domestic products.

From the province where the registrant was located, a total of 169 ophthalmic material registrants have entered the healthcare security consumables classification directory, of which 37 were located in Jiangsu Province, ranking first in the country; Afterwards, Guangdong Province and Shandong Province ranked second and third with 20 and 19 respectively.

 From the perspective of registrants, there were a total of 386 domestic product registration certificates for ophthalmic materials in the healthcare security consumables classification directory, belonging to 169 registrants. On average, each registrant had about 2 product registration certificates, among which the top registrants with the highest number of certificates were Suzhou Beele Health Science and Technology Co., Ltd., Eyebright Medical ‘, OVCTEK, CENTURE HEALTHCARE, etc; The leading registrants in terms of product quantity were Beele Health Science and Technology, Changchun Yunai, Eyebright Medical, and Hydron. Suzhou Beele Health Science And Technology had the highest number of products and registration certificates, with 61 and 55 respectively.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：Qingbaishijao

Translated & edited：Bradyknow