Monday, 11, August, 2025
/ Published in China, Medical Devices, News
Medical Device Clinical Evaluation Exemption 2025 Catalogue Released by NMPA for Overseas Manufacturers
The Catalogue of Medical Devices Exempt from Clinical Evaluation (2025), newly issued by China’s NMPA, came into effect immediately upon its release on May 13, 2025. The update introduces new exemptions and revisions that directly affect clinical evaluation requirements for international manufacturers seeking product registration in China.
Key Updates of the 2025 Catalogue
The “Catalogue of Medical Devices Exempt from Clinical Evaluation (2025)” includes 28 new items, 30 revisions of product descriptions, and 3 revisions of product management categories and classification codes. The newly added products cover a wide range of medical fields, from diagnostic equipment to therapeutic devices, providing clearer guidance for the registration management of different categories of medical devices. More precise definitions have also been made for the descriptions and classification codes of some products, which helps to enhance the scientific and accurate management of medical device classification, facilitating better understanding and implementation of relevant requirements by regulatory authorities, enterprises, and medical institutions. Detailed content of the catalogue update: new items are listed in Appendix table 1 at the end of the article; revisions of product descriptions are in Appendix table 2; revisions of product management categories and classification codes are in Appendix table 3.
Impact of the Catalogue Update on Overseas Manufacturers’ Product Registration and Response Strategies
Impact on Product Registration for Overseas Manufacturers
Overseas manufacturers need to carefully study the 2025 catalogue to accurately determine whether their products fall within the scope of exemption from clinical evaluation. If the product is included in the catalogue, they can take advantage of this policy to bypass the clinical evaluation process, accelerate the registration process, and seize market opportunities.
Response Strategies for Overseas Manufacturers
Overseas manufacturers can prioritize the layout of mature product lines. Class II devices that have been certified in the European and American markets, if matching the catalogue, can bypass the clinical evaluation process and speed up registration.
Due to the implicit limitations on product technical pathways in the exemption catalogue, products with innovative designs may be excluded from the exemption list. Companies can refer to the technical pathways in the exemption catalogue at the early stage of research and development to avoid increased registration costs due to innovation.
Further Information
To read the original announcement about the Catalogue of Medical Devices Exempt from Clinical Evaluation (2025) released by China’s NMPA, please click here.
If you are a medical device manufacturer with questions about whether your product qualifies for clinical evaluation exemption under the 2025 NMPA catalogue, please contact Cisema.
Appendix
Table 1: Newly-added products
| Classification Code | Product Name | Product Description | Category | Remark |
|---|---|---|---|---|
| 02-15-00 | Personalized 3D printed surgical models | It is made of polymer materials (such as: photosensitive resin, polylactic acid, etc.). According to the patient’s medical image data, through data conversion and three-dimensional reconstruction design, the reconstructed three-dimensional map is printed as a solid map by using a 3D printer to display the simulated human model of the anatomical structure of the bone lesion… | Ⅱ | New |
| 03-13-06 | Delivery intracranial balloon dilation catheter | Used for balloon dilation of narrowed sites of intracranial arteriovenous vessels. Not for use with thrombectomy stents. Consists of a balloon, catheter, catheter holder, and radiographability marker. Mature design and mechanism. Excludes drug-device combinations and special designs. | Ⅲ | New |
| 07-03-03 | Non-invasive ambulatory blood pressure recorder | Includes a blocking cuff, sensor, inflator, measuring circuit, power supply, and recorder. Measures blood pressure continuously using non-invasive methods. Must meet YY9706.230 and include clinical accuracy data. | Ⅱ | New |
| 03-13-28 | Atrial septal puncture sheath | Includes sheath, dilator, guidewire, and puncture component. Used to insert cardiovascular catheters into the left side of the heart. Composition is mature. Excludes new designs or drug-device combinations. | Ⅲ | New |
| 05-04 | Radiation therapy equipment | 05-04 Class II products under the sub-catalog are exempt from clinical evaluation. | Ⅱ | New, formerly 251-255 merged |
| 06-14-01 | Ear endoscopy | Rigid endoscopes with imaging and illumination systems. Used to observe ear anatomy. Produces and magnifies optical images through a fiber system and camera or eyepiece. | Ⅱ | New |
| 06-14-01 | Spinal endoscopy | Rigid optical endoscopes with objective, image rotation, and eyepiece systems. Used to observe the spine. Light provided via optical fibers. Converts images for visualization. | Ⅱ | New |
| 07-03-06 | Electromyography evoked potential instrument | Includes main unit, stimulator, monitor, and accessories. Collects and amplifies EMG signals. Must comply with YY 9706.240-2021. Excludes automatic diagnosis. | Ⅱ | New |
| 07-08-01 | Telemetry monitoring system | Includes transmitter, receiver, optional central station. Collects and wirelessly transmits physiological data like ECG, SpO2, and NIBP. Must meet GB/YY standards. Requires accuracy data. | Ⅱ | New |
| 07-08-02 | Remote monitoring system | Patient data collected and transmitted to remote servers for analysis, alarms, and storage. Requires accuracy research data. Includes monitoring terminal, router, server. | Ⅱ | New |
| 08-01-00 | High-flow respiratory humidification therapy device | Provides warm, humidified gas to spontaneously breathing patients for therapy. | Ⅱ | New |
| 10-02-03 | Indwelling needles for dialysis | Used for arteriovenous fistula puncture during hemodialysis. Made from polymer/stainless steel. Sterile, single-use. Excludes new materials or new mechanisms. | Ⅲ | New |
| 14-01-06 | Single-use sterile injection needles | Includes needle holder, multi-needle tube, and sheath. Used for dermal sodium hyaluronate injection. Excludes new materials/functions. | Ⅲ | New |
| 14-01-06 | Single-use sterile side-hole blunt needle | Used to inject sodium hyaluronate gel for facial filling. Used only by qualified professionals in clinical settings. Excludes new tech/functions. | Ⅲ | New |
| 14-01-06 | Single-use endoscopic injection needle | Used with endoscopes for GI bleeding treatments. Includes needle, tubes, handle, connectors. Excludes new technologies. | Ⅲ | New |
| 14-01-08 | Liposuction needles | Header and side-hole tube. Used with liposuction machine or syringe to extract subcutaneous fat. | Ⅱ | New |
| 14-05-07 | Eustachian tube balloon catheter | Balloon catheter system for expanding the eustachian lumen during diagnostic/therapeutic procedures. Sterile, single-use. | Ⅱ | New |
| 17-01-05 | Oral digital impression machine | Host, scan head, and software used to scan intraoral structures for orthodontics or restoration. No caries detection. | Ⅱ | New |
| 17-06-03 | Temporary crowns, bridges | Made of approved resin via light-curing, stacking, or CNC turning. Used as transitional restoration before permanent dental restoration. | Ⅱ | New |
| 17-06-03 | Preformed polymer-based crown and bridge materials | Contains TEGDMA, UDMA, BISGMA, glass powder, etc. For CAD/CAM-based dental restorations. Excludes new materials/functions. | Ⅲ | New |
| 20-03-03 | Disposable acupuncture point acupuncture | Includes needle body, handle, and sheath. Semi-beveled tip. Used for loosening or peeling diseased tissues via acupuncture. | Ⅱ | New |
| 22-01-03 | Blood cell morphology analysis instrument | Used for blood/body fluid analysis using impedance, colorimetry, or laser scattering. Excludes AI-based instruments. | Ⅱ | New |
| 22-04-07 | Immunoassay all-in-one machine | Includes multiple analysis modules for detecting analytes in human samples. Supports two or more detection principles. | Ⅱ | New |
| 22-04-08 | Indirect immunofluorescence analysis instrument | Includes fluorescence microscope and software. Captures and interprets digital images from immunofluorescence slides. | Ⅱ | New |
| 22-04-09 | Biochemical immunoassay instrument | Biochemical and immunoassay modules for qualitative/quantitative analysis. Works with adapted reagents. | Ⅱ | New |
| 22-09-03 | Urinalysis system | Includes dry chemistry and morphology modules for qualitative and quantitative analysis of urine/body fluids. | Ⅱ | New |
| 22-09-07 | Other body fluid analysis instruments | Uses reflectance photometry for routine testing of cerebrospinal, thoracic, or joint fluids. Includes detection and computer modules. | Ⅱ | New |
| 22-09-08 | Other instruments for the analysis of body fluid morphology | Includes transfer, suction, microscopy, and image processing modules. Used to analyze sperm, cerebrospinal fluid, or joint effusion morphology. | Ⅱ | New |
Table 2: Product description revisions
| Classification Code | Product Name | Product Description | Category | Remark |
|---|---|---|---|---|
| 01-03-01 | High-frequency surgical equipment | It usually includes the high-frequency generator host and other related accessories (foot switches, surgical electrodes, neutral electrodes, etc.); The use of high-frequency current (frequency range: 200k-5MHz) directly through the human body to produce thermal effect, so as to routinely cut and coagulate human tissues; It is used for routine cutting and coagulation of human tissues in traditional electrosurgery. The frequency range of the high-frequency generator should be limited to 200k-5MHz; The scope of application is limited to conventional tissue cutting and coagulation surgery (general surgery, otolaryngology, neurosurgery, gynecology, laparoscopic surgery, etc.); It does not include special clinical applications or methods of use, such as plasma cutting coagulation, large vessel closure, etc. | Ⅲ | Revise the product description. |
| 01-03-04 | Plasma surgical electrodes | Bipolar attachment for plasma surgical equipment. It usually consists of an electrode tip, an electrode shaft, a handle, a cable, a connector, and a liquid line. It is used in conjunction with the plasma surgical equipment host and perfusion pump, and is suitable for cutting and coagulation of soft tissues in the environment of normal saline or other electrolyte solutions under open surgery or endoscopic surgery. | Ⅱ/ Ⅲ | Revise the product description. |
| 01-03-04 | Single-use cathode plates for high-frequency surgical equipment | The cathode plate for disposable high-frequency surgical equipment is usually composed of isolation paper, conductive adhesive, aluminum foil, base lining (such as polyethylene foam or non-woven acrylic pressure-sensitive adhesive) and electrode wires, which are divided into different models and specifications according to the conductive medium (metal electrode conductive/ionic conductive adhesive conductive), user group (adult/child), number of electrodes (unipolar/bipolar) and shape (square/oval), and whether there is a wire; Connect the human body and high-frequency surgical equipment, provide a high-frequency current loop with low current density, and prevent human burns; The other pole in the bipolar is used for the alarm loop of high-frequency surgical equipment. | Ⅱ | Revise the product description. |
| 01-03-04 | High-frequency surgical attachments | Accessories for high-frequency surgical equipment, usually consisting of surgical handles, cables for surgical accessories, surgical connectors and surgical electrodes, which can include hand switches and can be attached to a cooling water supply system. Accessories can be divided into several categories, models and specifications according to the working principle, additional functions such as cooling, technical parameters, expected functions, etc.; Can be supplied in sterile/non-sterile format; Both unipolar and bipolar forms are available. It is equipped with high-frequency surgical equipment for tissue cutting, separation, electrocoagulation and hemostasis, tissue coagulation, etc. in various clinical open surgical operations. Plasma surgical electrodes and closure instruments for vascular closure are not included. | Ⅱ | Revise the product description. |
| 03-13-22 | Intravascular recovery device | It is used to capture and remove foreign bodies that fall off after the failure of intravascular interventional devices, such as stents, broken catheters and guidewires, or to capture guidewires to establish tracks during auxiliary occluder implantation. It usually consists of a gripping device, a rod, a control device and a sheath tube, which has a foreign object gripping function, can be accessory, and can be coated. It is equivalent to a product that has been approved for domestic registration. The product composition materials are mature, except for new structural design, new mechanism of action, drug-device combination products, and neurovascular applications. | Ⅲ | Revise the product description. |
| 04-16-03 | 3D printed osteotomy guide | Orthopedic surgery kit to match the patient’s anatomy. It is made of polymer polyamide material, metal material or photosensitive resin material, etc., and is made by 3D printing. Supplied non-sterile and sterilized for single use. Intended for use in specific patient orthopedic surgery for positioning, orientation, and protection. | Ⅱ | Revise the product description. |
| 06-14-03 | Electronic laparoscope | The product is composed of an objective lens end, a mirror body, a light guide connector and a video connector. An image sensor at the tip (usually a CCD or CMOS) converts the received optical signal into an electrical signal, which is processed by an image processing device and viewed on a display. The product is used for observational imaging in abdominal surgery. Products can include built-in light sources. | Ⅱ | Revise the product description. |
| 06-14-03 | Electronic nasopharyngeal endoscopy | The flexible electronic endoscope is generally composed of a head end, a bending part, an insertion part, an operating part and a part connected with the electrical and light source, and may contain a working channel. The photoelectric conversion device at the tip converts the received optical signal into an electrical signal and observes it on the display through a camera system. Images are provided through a video monitor for observation, diagnosis, and treatment of the upper respiratory tract such as the nose and throat. Products can include built-in light sources. | Ⅱ | Revise the product description. |
| 06-14-03 | Electronic lower gastrointestinal endoscopy | The flexible electronic endoscope is generally composed of a head end, a bending part, an insertion part, an operation part and an electrical and light source connection part, and generally contains a working channel. The photoelectric conversion device at the tip converts the received optical signal into an electrical signal and observes it on the display through an image processing system. Images are provided through a video monitor for observation, diagnosis, and photography of the lower gastrointestinal tract (excluding the small intestine). Products can include built-in light sources. | Ⅱ | Revise the product description. |
| 06-14-03 | Electronic vesicoureteral pelvis endoscopy | The flexible electronic endoscope is generally composed of a tip end, a bending part, an insertion portion, an operation part and an electrical and light source connection part, which may contain a working channel. The photoelectric conversion device at the tip converts the received optical signal into an electrical signal and observes it on the display through an image processing system. The video monitor provides images for observation, diagnosis, photography, and treatment of the urethra, bladder, ureter, and renal pelvis. Products can include built-in light sources. Can be designed for reuse or single use. | Ⅱ | Revise the product name and product description. |
| 07-03-06 | EEG machine | The EEG machine can be composed of an amplifier input box, a computer, a monitor, special software, electrodes, and can also include a flash lamp, a flash controller, a printer, etc., which can be divided into several models according to the design, type, technical parameters, additional auxiliary functions, etc., for the detection, processing, display and storage of human brain electrophysiological signals, excluding the automatic diagnosis part. The product performance index adopts the applicable part of the following reference standards, such as: GB9706.26-2005 Medical Electrical Equipment Part 2-26: Special requirements for the safety of EEG machines. | Ⅱ | Revise the product description. |
| 07-03-06 | Electromyography machine | The electromyography machine is mainly composed of a host and a stimulating electrode, and can also include a computer, special data management software and a printer, which can be divided into several models according to the design, type, technical parameters, additional auxiliary functions, etc.; It is used for the collection, processing and analysis of human electromyography signals and nerve conduction data, excluding the automatic diagnosis part. The product performance index adopts the applicable part in the following reference standards, such as: YY 9706.240-2021 Medical electrical equipment Part 2-40: special requirements for basic safety and basic performance of electromyography and evoked reaction equipment. | Ⅱ | Revise the product description. |
| 07-09-03 | Sleep apnea monitoring devices | The sleep apnea monitor is usually composed of a recorder, EEG electrodes, eye movement electrodes, electromyography electrodes, chest/abdominal breathing probes, body position sensors, nasal airflow tubes, pulse oximetry and electrocardiogram electrodes, sleep data processing software (excluding automatic analysis and diagnosis functions), etc. Physiological parameters during sleep were recorded for analysis. It is used to record various physiological parameters during sleep, and to analyze and diagnose sleep disorders, sleep-disordered breathing, sleep apnea, and hypopnea syndrome. | Ⅱ | Revise the product description. |
| 08-06-02 | Breathing tubes | Usually a bellows with a “herringbone” or “one” structure, some of the pipes can be axial telescopic, and the herringbone structure of the pipe is composed of suction and exhalation branches, which are generally made of plastic or silicone rubber materials. The heated breathing circuit also includes a heating wire and a power adapter. Single-use or reusable. or bellows or hoses, usually in a zigzag structure, or with a mouthpiece, generally made of plastic or silicone rubber material. | Ⅱ | Revise the product description. |
| 08-06-02 | Breathing lines for anesthesia machines and ventilators | The breathing tubing for anesthesia machine and ventilator is made of polyvinyl chloride and other applicable materials, and is divided into two categories: anesthesia machine tubing and ventilator tubing, anesthesia machine tubing is composed of Y-shaped joints and bellows, and ventilator tubing is composed of Y-shaped joints, bellows and rotary elbows, the two types of pipelines can be combined, and can be equipped with air storage bags and masks, which can be divided into several models and specifications according to different materials, designs, combinations, use objects (adults/children), technical parameters, optional accessories, etc.; It is used for the tubing connection between the interface of anesthesia machine and ventilator and the oxygen supply mask. The product performance index adopts the applicable part of the following reference standards, such as: YY 0461-2003 breathing line for anesthesia machine and ventilator. | Ⅱ | Revise the product description. |
| 13-01-01 | Metal-locked bone plates | It is made of stainless steel, pure titanium and titanium alloy materials in accordance with GB 4234.1, GB/T 13810, ISO 5832-1, ISO 5832-2, ISO 5832-3, ISO 5832-11 and other standards, through conventional machining, heat treatment and surface treatment processes (such as passivation, electrolytic polishing, anodizing, etc.), excluding products with new structural design, excluding innovative processes such as 3D printing. It is suitable for internal fixation of limb fractures and osteotomy and orthopedics. | Ⅲ | Revise the product description. |
| 13-01-01 | Anatomical metal plate (non-locking) | For the structure of this kind of product, see YY 0017, which is made of stainless steel, pure titanium and titanium alloy materials in accordance with GB 4234.1, GB/T 13810, ISO 5832-1, ISO 5832-2 and ISO 5832-3 standards, and is made by conventional machining, heat treatment and surface treatment processes (excluding innovative processes such as 3D printing). It is suitable for internal fixation of limb fractures and osteotomy (including osteotomy and orthopedics). | Ⅲ | Revise the product description. |
| 13-01-01 | Straight metal bone plate (non-locking) | For the structure of this kind of products, see YY 0017, which is made of stainless steel, pure titanium and titanium alloy materials in accordance with GB 4234.1, GB/T 13810, ISO 5832-1, ISO 5832-2 and ISO 5832-3 standards, and is made by conventional machining, heat treatment and surface treatment processes (excluding innovative processes such as 3D printing). It is suitable for internal fixation of fractures of long bones and diaphysis of limbs and osteotomy and orthopedics (including osteotomy and orthopedics). | Ⅲ | Revise the product description. |
| 13-01-01 | Angled metal bone plates | For the structure of this kind of products, see YY 0017, which is made of stainless steel, pure titanium and titanium alloy materials in accordance with GB 4234.1, GB/T 13810, ISO 5832-1, ISO 5832-2 and ISO 5832-3 standards, and is made by conventional machining, heat treatment and surface treatment processes (excluding innovative processes such as 3D printing). It is suitable for internal fixation of fractures of the long bones of the limbs (including osteotomy and orthopedics). | Ⅲ | Revise the product name and product description. |
| 13-01-01 | U-nails | The structure of this type of product refers to ISO 8827, which is made of stainless steel and titanium alloy materials in accordance with GB 4234.1, GB/T 13810, ISO 5832-1 and ISO 5832-3 standards, and is made by conventional machining, heat treatment and surface treatment processes (excluding innovative processes such as 3D printing). It is suitable for internal fixation of limb fractures. | Ⅲ | Revise the product description. |
| 13-06-03 | Craniomaxillofacial plate system | It is made of stainless steel, pure titanium and titanium alloy materials that comply with GB 4234.1, GB/T 13810, ISO 5832-1, ISO 5832-2 and ISO 5832-3 standards, and is made by conventional machining, heat treatment and surface treatment processes (excluding innovative processes such as 3D printing), and does not include new structural design. It is suitable for internal fixation of craniomaxillofacial fractures (including osteotomy and orthopedics). Except for repairing, covering, or filling bone defects or holes. | Ⅲ | Revise the product description. |
| 14-05-06 | Single-use chest drain and puncture kit | The product is made of medical silicone rubber/polyurethane and other raw materials, which are used to drain patients’ fluids, exudates or gases into the body. The puncture kit can be composed of a dilator, a puncture needle, a guidewire, a catheter sheath and accessories, etc., to establish a subcutaneous artificial channel and assist in the placement of the drainage tube. The exemption does not include products that use new materials, new mechanisms of action, and new functions. | Ⅱ | Revision of classification codes and product descriptions. |
| 14-10-08 | Liquid, paste dressings | It is usually a solution or ointment (excluding gels) and contains ingredients that do not have pharmacological effects and cannot be absorbed by the body. Supplied sterilely. By forming a protective layer on the surface of the wound, it acts as a physical barrier. It is used to cover non-chronic wounds such as small wounds, abrasions, and cutting wounds. The exemption does not include: (1) products with indications that can promote epithelialization, guide tissue regeneration, promote wound healing, reduce pain, be antibacterial, anti-infective, antiviral, stop bleeding, dissolve necrotic tissue, reduce scarring, etc.; (2) Products that claim to be used for internal wounds, third-degree burns, infected wounds, wounds with a lot of necrotic tissue, and patients with wound sepsis; (3) Products containing active ingredients: such as medicines/medicinal active ingredients, biological products/bioactive ingredients, silver, disinfectants, etc.; (4) Other new products, such as new materials, new mechanisms of action, and new functions. | Ⅱ | Revise the product description. |
| 17-07-07 | Orthodontic retainers | Products are made of medical-grade PVC material, polyethylene terephthalate (PET), thermoplastic polyurethane or medical silicone, or from resin material and stainless steel wire. It is used to consolidate the efficacy of orthodontic treatment of dental deformity. The exemption does not include products that are different from the materials, technologies, design or mechanism of action, functions and other products that are already on the market. | Ⅱ | Revise the product description. |
| 18-07-04 | Granule cell removal solution | Generally, it is a solution composed of hyaluronidase, inorganic salts, acid-base buffer components, antibiotics, human serum albumin, water and other components. It is used to remove egg granule cells in assisted reproductive technology. The product is equivalent to the product that has been approved for domestic registration. Novel mechanisms of action are excluded. | Ⅲ | Revise the product description. |
| 22-04-04 | Immunochromatographic analysis instruments | It is usually composed of photoelectric detection module, mechanical scanning control module, control motherboard module, information acquisition module, etc. The principle is generally to convert the reflectance signal of the detection reagent card into a photoelectric signal through the sensor, and convert the photoelectric signal into the corresponding concentration value or threshold through the calibration information, and analyze the analyte. Used in conjunction with adapted reagents for the qualitative and/or quantitative analysis of analytes in human samples. | Ⅱ | Revise the product name. |
| 22-04-06 | Immunoscatter turbidity analysis instrument | It is usually composed of an optical module, an inspection module, a computer system, etc. The principle is generally immunoturbidimetry. Used in conjunction with adapted reagents for the qualitative and/or quantitative analysis of analytes in human samples. | Ⅱ | Revise the product name. |
| 22-06-08 | Helicobacter pylori breath analysis instrument | It usually consists of a sampling module, an air purification and drying module, an optical module, a measurement module, an electrical control module and a gas collection module. The principle is generally a breath test. It is used for clinical diagnosis of diseases caused by Helicobacter pylori infection. | Ⅱ | Revise the product name. |
| 22-11-04 | Single-use vacuum blood collection containers | The disposable vacuum blood collection container is usually composed of a tube and a head cap, The EEG machine can be composed of an amplifier input box, a computer, a monitor, special software, electrodes, and can also include a flash lamp, a flash controller, a printer, etc., which can be divided into several models according to the design, type, technical parameters, additional auxiliary functions, etc., for the detection, processing, display and storage of human brain electrophysiological signals, excluding the automatic diagnosis part. The product performance index adopts the applicable part of the following reference standards, such as: GB9706.26-2005 Medical Electrical Equipment Part 2-26: Special requirements for the safety of EEG machines.ith or without additives or additives attached to the inner wall of the tube, and is used in conjunction with a disposable blood collection needle for the collection, transportation and storage of human venous blood. The product performance index adopts the applicable part of the following reference standards, such as: YY/T 0314 “Disposable Venous Blood Sample Collection Container”. | Ⅱ | Revise the product description. |
Table 3: Revisions to product management categories and classification codes
| Classification Code | Product Name | Product Description | Category | Remark |
|---|---|---|---|---|
| 03-14-02 | Head nails | The product is usually composed of a body, a base, an O-ring, and a rubber cap assembly, in which only the main body is in contact with the human body. The main body should be made of stainless steel according to GB 4234.1, ISO 5832-1, ASTM F899 or Ti6Al4V, Ti6Al4VELLI titanium alloy materials according to ISO 5832-3, GB/T 13810 standard, and the product should be used in conjunction with a skull fixator to fix the patient’s head and neck in a specific position during surgical procedures requiring severe repair of the skull. The product is non-implantable, is only used intraoperatively, has short-term contact with the human body, and is removed immediately after surgery. | Ⅱ | Revision of the classification code. |
| 03-13-00 | Transjugular intrahepatic puncture instrument | It usually consists of a core-filled needle, a catheter, a rigid cannula, a dilator, a catheter sheath, a dilator, and a guidewire. It is used for transjugular intrahepatic portal vein puncture to perform intrahepatic shunt surgery of the portal vein to reduce portal venous pressure. The composition of the product is mature, the mechanism of action is clear, and it is equivalent to the products that have been approved for domestic registration. Except for the design of new structures and mechanisms of action; Except for drug-device combination products. | Ⅱ | Revision of management categories and classification codes. |
| 14-05-06 | Single-use chest drain and puncture kit | The product is made of medical silicone rubber/polyurethane and other raw materials, which are used to drain patients’ fluids, exudates or gases into the body. The puncture kit can be composed of a dilator, a puncture needle, a guidewire, a catheter sheath and accessories, etc., to establish a subcutaneous artificial channel and assist in the placement of the drainage tube. The exemption does not include products that use new materials, new mechanisms of action, and new functions. | Ⅱ | Revision of classification codes and product descriptions. |
