Multiple Chinese MedTech Firms, Including WisMed and Maidi Medical, Secure New Medical Device Registrations in June

　　【Pharmaceutical Network Industry Dynamics】The medical device product registration certificate is an important means to ensure public health and safety, and it is crucial for the medical device industry. It is an important credential for medical device manufacturers to gain market access and also the legal basis for consumers to purchase and use medical devices. Medical device products that obtain the registration certificate will be allowed to be sold and used in the market, which helps enhance the market competitiveness of related enterprises. Since June 2024, a group of pharmaceutical companies have announced obtaining medical device registration certificates, which is worth noting.
 

On the evening of June 11, VISHEE announced that the company had recently received one Medical Device Registration Certificate issued by the Jiangsu Provincial Drug Administration. The product involved is an Extracorporeal Shock Wave Treatment System, which is suitable for adjuvant treatment of periarthritis of the shoulder, calcific tendinitis of the shoulder, lateral epicondylitis of the humerus, subacromial pain syndrome, trochanteric pain syndrome of the femur, patellar tip syndrome, osteochondritis of the tibial tuberosity, medial tibial stress syndrome, Achilles tendinitis, plantar fasciitis, myofasciitis, and nonspecific low back pain.
 

The acquisition of the above-mentioned Medical Device Registration Certificate is beneficial for further expanding the company's core product layout in the rehabilitation specialty, enriching the company’s rehabilitation specialty product portfolio, continuously meeting diversified market demands, and enhancing the company's comprehensive competitiveness in areas such as rehabilitation therapy and pain management.
 

On the same day, Lefan Healthcare announced that it had recently successfully completed the application for the modification of the medical device registration certificate for its electronic blood pressure monitor. The main modification was the addition of the product model BT106 to the product model list. This electronic blood pressure monitor, composed of a main unit and a cuff, is suitable for measuring blood pressure and pulse rate in adults with an arm circumference of 22cm-45cm. In addition, Lefan Healthcare has also obtained a new medical device registration certificate for its electronic blood pressure monitor, which is suitable for measuring blood pressure and pulse rate in adults with an arm circumference of 22cm-32cm and 22cm-42cm. This will help Lefan Healthcare further consolidate its quality advantage in medical-grade high-standard products, enhancing the comprehensive competitiveness and market expansion capabilities of the company's products.
 

On June 5, Maide Medical announced that its controlling subsidiary, Zhejiang Maide Shun Contact Lens Co., Ltd., had recently obtained the "People's Republic of China Medical Device Registration Certificate" approved by the National Medical Products Administration. The product name is Soft Hydrophilic Contact Lenses, which are suitable for correcting myopia in patients without contraindications. The acquisition of the above-mentioned medical device registration certificate will help expand the company’s business scope, enrich its product categories, optimize its business layout, promote the gradual implementation of the company’s long-term strategic plan, and further enhance the company’s comprehensive competitiveness, playing a positive role in promoting the company’s sustainable development.
 

June 5th, news revealed that Ruiang Gene recently announced its wholly-owned subsidiary, Suzhou Yuntai Biopharmaceutical Technology Co., Ltd., obtained the "Medical Device Registration Certificate (In Vitro Diagnostic Reagent)" issued by the National Medical Products Administration for its BCR-ABL P210 Fusion Gene Detection Kit (Fluorescent RT-PCR Method). This achievement further enhances Ruiang Gene's product portfolio in the leukemia field, meets the increasing standardization demands of hospital diagnostics, and strengthens the company’s core competitiveness.
 

On the evening of June 4, Sanyou Medical announced that the company had recently received the "Tendon and Ligament Fixation Screw" Medical Device Registration Certificate of the People's Republic of China issued by the National Medical Products Administration. The product name is "Tendon and Ligament Fixation Screw," which is suitable for the connection and fixation of tendons, ligaments, and bones in the shoulder, knee, finger, wrist, ankle, and toe joints.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice for anyone.