Hainan Achieves Rapid Growth in Class III Medical Devices with 28 Approvals, Doubling Yearly Over the Past Three Years

　　【Pharmaceutical Network Product InformationRecently, a Class III medical device "Absorbable Surgical Suture" independently developed by Hainan Baimaike Medical Technology Co., Ltd. has been approved for marketing by the National Medical Products Administration. The product is a sterile absorbable monofilament suture with barbs made from a copolymer material consisting of 75% glycolide and 25% caprolactone, mainly used for soft tissue suturing where absorbable sutures are suitable. This is the seventh Class III medical device product approved in the province this year, representing a year-on-year increase of 75%.
 

Hainan Provincial Drug Administration Attaches Great Importance to Supporting and Cultivating the R&D and Registration of Class III Medical Device Products, Implementing Multiple Measures for Continuous and Precise Guidance and Assistance. Currently, 28 Class III medical device products in the province have been approved for marketing, with the number of approvals doubling on average each year over the past three years.
 

In addition to absorbable surgical sutures, Hainan has seen the approval and market launch of multiple Class III medical device products this year, showing a thriving development trend.
 

For example, in February this year, Susheng Biotech (Hainan Susheng Biotechnology Co., Ltd.) announced good news: its "Polyester Collagen Bone Repair Material," introduced from Switzerland, obtained the Class III Medical Device Registration Certificate issued by the National Medical Products Administration. This product became the first medical device approved for domestic marketing under the collaborative model of "R&D and application in Lecheng + production in Haikou." The product is a novel composite bioactive bone substitute, composed of bovine cancellous bone (98.5±0.5%), poly-L-lactide-co-ε-caprolactone (1.0±0.2%), and gelatin (from porcine origin, 0.5±0.1%). Its microstructure is very similar to that of human bones. It is specifically developed for bone regeneration in reconstructive surgery and is suitable for traumatology, oncology, and spinal surgery in orthopedics, as well as for filling and repairing bone defects.
 

In January, Carl Zeiss's femtosecond laser corneal refractive treatment machine was approved for marketing in China with the assistance of real-world data evaluation from Letong. The new generation of ZeissRobotVISUMAX 800, a laser vision correction device based on the concept of intelligent robotics, ultra-fast treatment time, and full-process digital connectivity, is equipped with the new SMILE pro surgical technology, completing single-eye scanning within 10 seconds. Since its introduction at the Boao Super Hospital in November 2022, it has successfully completed over 270 treatment surgeries, with 62 cases participating in real-world research. The product’s launch further meets the demand in the Chinese market for safer and more effective laser vision correction solutions while enhancing the treatment experience for patients.
 

In addition to the aforementioned products, Hainan Baimaike Medical Technology Co., Ltd.'s gelatin sponge embolic microspheres were approved in January this year. Gelatin sponge embolic microspheres, as an important interventional treatment material, play a key role in the treatment of various diseases. They can block blood vessels and cut off the blood supply to the affected area, thereby achieving the therapeutic purpose. For example, in cancer treatment, they can be used to embolize tumor blood vessels and inhibit tumor growth.
 

The rapid growth in the number of medical device products approved in Hainan is inseparable from the high attention and strong support of the Hainan Provincial Medical Products Administration. The provincial administration actively seeks to maintain regular and smooth communication with the Center for Medical Device Evaluation under the National Medical Products Administration, providing professional consultation and guidance for innovative medical devices and key products before their registration applications are submitted, enabling companies to have a clear direction and avoid unnecessary detours. For key R&D projects of Class III medical devices, "one-on-one" precise guidance and assistance are provided, starting from the product design and development stage, helping enterprises clarify technical pathways, formulate reasonable R&D plans, and assist in perfecting registration application materials. At the same time, efforts are made to implement the pilot program of pre-evaluation, giving close attention and full-process tracking services to products included in the pre-evaluation pilot scope by the National Medical Products Administration. Currently, a total of 5 products in 2 batches in Hainan have been selected as key products for pre-evaluation.
 

In the future, with the continuous support of policies and the advancement of corporate innovation and R&D, Hainan is expected to promote the approval and market entry of more high-quality, high-tech Class III medical device products. This will inject strong momentum into the high-quality development of Hainan Free Trade Port's biopharmaceutical industry and also bring more advanced medical solutions to patients in China and even globally.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.