Weike Medical Submits IPO Prospectus Following C-round Financing of Hundreds of Millions of RMB

01

02

Navigantis Reports Clinical Cases of Neurovascular Surgical Robots

Five Fast-Growing Segments in the 2025 Medical Device Market

Recently, GE Healthcare has partnered with RadNet, a well-known third-party independent imaging center, and its subsidiary DeepHealth. The two parties will integrate their advanced technologies in depth, incorporating DeepHealth's mature artificial intelligence system SmartMammo™ into GE Healthcare's leading Pristina series of mammography products. They will also further develop additional AI tools to drive technological innovation and practical application of artificial intelligence in the field of breast imaging. Both parties acknowledged that they will jointly address key challenges in the imaging value chain by applying AI solutions, further accelerating digital-physical integration to foster innovative large-scale breast screening and efficient workflow transformation. Over the next five years, RadNet imaging centers will be the first to fully utilize the Pristina digital mammography systems equipped with the SmartMammo solution, replacing their existing equipment, thereby broadening pathways for women’s breast diagnosis and treatment.

On January 2, Autobio Diagnostics and Shanghai Pharmaceuticals Supply Chain signed a strategic cooperation agreement aimed at optimizing the supply chain, reducing costs, improving efficiency, and providing higher-quality products and services. Focusing on the in vitro diagnostics (IVD) field, Autobio Diagnostics is regarded as a potential stock in China's IVD industry. This collaboration will strengthen the procurement and distribution of IVD product services.

Recently, the Inspection Center of the National Medical Products Administration has formulated the "Basic Requirements for the Quality Management System of Provincial Medical Device Inspection Institutions (Trial)", which stipulates: Inspection institutions should have clear institutional responsibilities, reasonably set up departments and positions, clarify responsibilities, authorities, and interrelationships, and assign staff members commensurate with their functions. In principle, the inspection and evaluation departments should be separately established. The main person in charge of the inspection institution should designate a quality system leader or management representative among the heads of the inspection institution to establish, implement, and maintain the effective operation of the quality management system, report on the operation status of the quality management system and improvement needs, and enhance employees' awareness of conducting inspections legally and in compliance while ensuring that the inspection quality meets customer requirements.

Recently, the Anhui Provincial Drug Administration, in reference to the relevant provisions of the "National Medical Products Administration Announcement on the Registration of Main Documentation for Medical Devices," issued and implemented an announcement regarding the registration of main documentation for Class II medical devices in Anhui Province. Scope of application for main documentation: The main documentation for medical devices is a form of technical documentation. This type of documentation is used to authorize medical device registration applicants to reference it as part of their registration submission when applying for medical device registration. The main documentation for medical devices applies to the issuance and modification of registration certificates for Class II medical devices (including in vitro diagnostic reagents) submitted by medical device registration applicants in Anhui Province.

Recently, Hainan issued the "Management Measures for Zero-Tariff Imported Pharmaceuticals and Medical Devices in the Hainan Free Trade Port," further expanding and clarifying the applicable scope of specially permitted imported pharmaceuticals and medical devices under "zero-tariff." It specifies that "zero-tariff" imported pharmaceuticals and medical devices include those already approved and registered in China, as well as specially permitted pharmaceuticals and medical devices used in Lecheng. It clarifies the qualification recognition for beneficiaries, disposal procedures, and the recognition process and usage standards for "zero-tariff" imported pharmaceuticals and medical devices. The "zero-tariff" imported pharmaceuticals and medical devices are only allowed for self-use by beneficiaries within the Lecheng Pilot Zone or for use by patients of beneficiaries within this zone. If a patient opens the smallest package and performs trial (use), installation, implantation, wearing, or similar actions within the Lecheng Pilot Zone, it is considered as having been used within the zone.

Recently, the U.S. Food and Drug Administration (FDA) released the "Guidance for Premarket Submission of Artificial Intelligence-Enabled Device Software Functions with Predetermined Change Control Plans." This guideline provides relevant recommendations on the information that should be covered in the Predetermined Change Control Plan (PCCP) for artificial intelligence-driven device software functions (AI-DSF) in premarket applications. Its purpose is to support iterative improvements by modifying AI-DSF while consistently ensuring the safety and effectiveness of the device. The FDA reviews the PCCP as part of the AI-enabled device’s premarket submission to ensure the device’s continued safety and effectiveness without requiring additional premarket submissions for each change described in the PCCP.

Recently, the 18th meeting of the 16th Shanghai Municipal People's Congress Standing Committee voted to pass the "Shanghai Pharmaceutical and Medical Device Management Regulations." The Regulations will come into effect on March 1, 2025. The Regulations encourage innovative research and development guided by clinical value, integrate and share resources, and promote the transformation, promotion, and application of new technologies. They clarify clinical trial requirements, encourage multi-center clinical trials conducted in different countries or regions, providing support for product acceleration to market and "going global"; they also specify that the municipal pharmaceutical regulatory department should strengthen pre-registration guidance for drugs and medical devices with significant clinical value and strong innovation. Support relevant entities in collaborating on clinical trials of cell and gene therapy drugs, encourage the development and insurance coverage of products related to clinical trials of cell and gene therapy drugs, and also clarify special requirements for cell and gene therapy drugs in production and business use, offering assistance.

Recently, the National Medical Products Administration (NMPA) Center for Medical Device Evaluation released the "Announcement on Matters Related to the Adjustment of Classification Codes for In Vitro Diagnostic Reagents in the Registration Application Form." The relevant adjustment information is as follows: Starting from January 1, 2025, the classification codes for in vitro diagnostic reagents will be filled in the format "6840-XX (Primary Serial Number)-XXXXX (Secondary Serial Number)." Applicants can select detailed product categories from the drop-down menu in the eRPS system. The specific categories should be filled in according to the primary and secondary serial numbers in the "In Vitro Diagnostic Reagent Classification Catalog." For example, the classification code for the COVID-19 nucleic acid detection kit, based on the catalog, is 6840-01-01152. If the application product is a multi-test combination product, fill in the primary serial number based on the intended use of the product, and the secondary serial number can choose a representative product category or "00000."

Recently, the 2024 Issue 4 Medical Device Quality Announcement released by the Henan Provincial Drug Administration shows that three batches of medical devices failed the sampling inspection. The non-conforming medical devices in this inspection include: Medical Electronic Thermometer, specifications and model: DT008, batch number: 221200899, non-conforming items: display range, resolution, maximum permissible error, measurement completion prompt function, low temperature and over-temperature prompt function, measurement time, memory function, automatic shutdown function. Electric Wheelchair, specifications and model: DYW-459-46A10, batch number: 221115, non-conforming items: external markings of equipment or equipment components, user manual. Custom Fixed Prosthesis, specifications and model: Metal Ceramic Bridge, batch number: 240811211, non-conforming item: surface roughness.

Recently, the Ministry of Finance of China officially released the "Notice on Launching Pilot Work to Address Abnormally Low Prices in Government Procurement in Relevant Free Trade Zones and Free Trade Ports." The Notice states: To promote fair competition in government procurement and advance high-quality and appropriate-price procurement, the Ministry of Finance has decided to carry out pilot work in the Beijing, Tianjin, Shanghai, Fujian, and Guangdong Free Trade Zones, as well as the Hainan Free Trade Port, to address issues related to abnormally low prices in government procurement. The so-called "abnormally low price" issue refers to situations where suppliers quote prices far below those of their peers or even below the cost of the product during government procurement. The Notice encourages purchasers to include in procurement documents a requirement for suppliers to provide quotations for the entire lifecycle costs, including subsequent dedicated consumables and upgrade service fees within the agreed period, as factors to be considered during the review process.