TX Q&A

Textual modifications based solely on original inspection report data are not permissible. It is essential first to consider whether changes in product design parameters and systems are involved. If such changes are involved, samples produced after the changes should be provided for inspection. If there are no such changes, and the original production quality system control meets the new standards, re-inspection is not necessary.

When using overseas clinical trial data for registration in China, applicants must submit the ethics opinions, clinical trial protocols, and clinical trial reports from the overseas institutions. These documents, including their format, content, and signatures, must meet the clinical trial quality management requirements of the country or region where the trials were conducted. Additionally, applicants should provide a detailed analysis of the differences in clinical trial-related factors between domestic and overseas trials, explaining the differences and the measures taken to address them. When necessary, documents related to the laws, regulations, norms, or standards on clinical trial quality management from the country or region of the overseas trial should also be submitted. Applicants must provide complete overseas clinical trial data without selection, and the overseas clinical trial report should include an analysis and conclusions of the complete clinical trial data.

The compatibility between metal powder and printing parameters involves the powder's production process and the key process parameters of the printing equipment. Regarding the production process, it is necessary to submit the fundamental principles and selection criteria (such as electrode induction melting gas atomization, plasma inert gas atomization, vacuum induction melting gas atomization, plasma rotating electrode atomization), the key process parameters (such as gas pressure, flow rate and temperature, the inner diameter and spray angle of the atomization nozzle, pressure and oxygen content in the atomization tower, current and rotation speed of the rotating electrode atomization process), and related research validation materials. As for the compatibility with the key process parameters of the printing equipment, considerations should include laser power, spot diameter, scanning speed, scanning spacing, powder layer thickness, printing direction, atmospheric protection, support structures, and the temperature of the forming chamber, along with submitting related research validation materials.

For tumor companion diagnostic gene mutation detection reagents, if the gene is known to have multiple mutation sites for the same companion diagnostic purpose (such as the same companion drug), then the subsequent product design should fully consider the coverage of mutation sites in combination with the product risk-benefit analysis, and the detection range of the sites should not be arbitrarily reduced for the ease of product evaluation. For example, when KRAS gene mutation is used for tumor companion diagnosis, because it is a negative companion diagnostic gene test and is related to adverse drug reactions, insufficient coverage of mutation sites may increase patient risk.

For active medical devices that have many accessories intended to act on the human body (including direct and indirect contact), in the potential biological risk management process, the biocompatibility evaluation work is suggested to be divided into the following three categories: 1. For those exempt from biocompatibility evaluation, it is recommended to refer to the National Food and Drug Supervision and Administration [2007] No. 345, and issue a descriptive document stating that the conditions specified in Article 4, Paragraph (1) have not occurred. 2. For those undergoing biocompatibility evaluation, it is recommended to follow the systematic approach diagram shown in GB/T 16886.1-2011 for the biological evaluation process during risk management, to select and evaluate the accessories. 3. For those undergoing biocompatibility testing, it is recommended to follow Appendix A of GB/T 16886.1-2011 to identify the data or tests that need to be supplemented for a complete risk assessment data set.

According to the "Guidelines for Compiling Technical Requirements for Medical Device Products" and other relevant requirements, the shelf life of corneal contact lenses does not need to be specified as a performance indicator in the product technical requirements and tested. The shelf life study materials should be submitted during registration application in accordance with relevant standards and requirements.

For active medical devices that come with numerous accessories, it is advisable to submit disinfection and sterilization documentation in a list format following the structure of the application form. This list should include the names of the accessories, disinfection/sterilization methods, whether they are for single use or reusable, and whether sterilization is performed by the manufacturer or the end user. Manufacturers who perform sterilization should clearly specify the sterilization process (methods and parameters) and the Sterility Assurance Level (SAL), and provide a sterilization validation report. For end-user sterilization, it is important to specify the recommended sterilization process (methods and parameters) and the basis for determining the recommended sterilization method. For products that can withstand two or more sterilizations, research data on the tolerance of the recommended sterilization method for the product should be provided. If the sterilization method used is likely to leave residues, it is necessary to clearly define the information about the residues and the methods used to handle them, and provide research data. For end-user disinfection, the recommended disinfection process (methods and parameters) and the basis for determining the recommended disinfection method should be clearly specified.

Procalcitonin test reagents are used for the in vitro quantitative determination of procalcitonin in human serum or plasma samples. These reagents are listed in the "Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials," where the intended use is specified for the detection of procalcitonin (PCT) content in human samples, primarily for the auxiliary diagnosis of bacterial infectious diseases. If an applicant declares the use of procalcitonin test reagents for the auxiliary diagnosis of bacterial infections, including assisting in diagnosing infections of varying degrees, they can apply under the exemption from clinical trials pathway. If the applicant declares other intended uses for the procalcitonin test reagents, these do not fall within the scope of the exemption catalogue, and clinical trials must be conducted to confirm the claimed intended uses.

According to the "Guidance for Technical Review of Medical Device Registration of Animal Origin" (2017 revised edition), the registration application for medical devices of animal origin must include research data that contains descriptions of the processes for inactivating and removing viruses and/or infectious agents during production, as well as data or relevant information validating the effectiveness of these processes. Validation data can be obtained through laboratory verification, from suppliers of animal-derived materials, or by evaluating the effectiveness of virus inactivation through literature or historical data. If the submitted validation data is not based on verification obtained from the product itself, an analysis and argument for applicability must be conducted.

Currently, in addition to fillers primarily composed of sodium hyaluronate or collagen, the following types of injectable fillers have been approved: 1. Fillers composed of sodium hyaluronate and hydroxypropyl methylcellulose: - Medical hydroxypropyl methylcellulose-sodium hyaluronate solution: A sterile gel solution composed of hydroxypropyl methylcellulose, sodium hyaluronate, and balanced salt solution. It is used for deep dermal to superficial subcutaneous injection to correct moderate to severe forehead wrinkles and nasolabial folds. - Medical sodium hyaluronate-hydroxypropyl methylcellulose gel: Mainly composed of cross-linked sodium hyaluronate particles, hydroxypropyl methylcellulose, phosphate sodium chloride buffer solution, and water for injection. It is used for subcutaneous shallow to deep filling to correct moderate to severe forehead wrinkles and nasolabial folds. 2. Fillers made of absorbable polyester materials formed into microspheres and supplemented with excipients: - Poly-l-lactic acid facial filler: This product consists of poly-l-lactic acid microspheres, mannitol, and sodium carboxymethylcellulose in a lyophilized powder, which must be reconstituted with 0.9% sodium chloride injection solution into a suspension before use. It is suitable for deep dermal injection to correct moderate to severe nasolabial folds. - Injectable poly-caprolactone microsphere facial filler: Composed of synthetically produced poly-caprolactone (PCL) microspheres, glycerin, hydroxymethylcellulose, and phosphate buffer solution. It is used for subcutaneous implantation to correct moderate to severe nasolabial folds. 3. Cross-linked sodium hyaluronate gel containing microspheres of L-lactic acid-ethylene glycol copolymer: Mainly composed of cross-linked sodium hyaluronate, L-lactic acid-ethylene glycol copolymer microspheres, lidocaine hydrochloride, and a phosphate buffer system. It is suitable for deep dermal, superficial, and deep subcutaneous injection to correct moderate and severe nasolabial folds. 4. Fillers containing non-degradable components (i.e., permanent fillers): - Collagen and PMMA subcutaneous implant system: This product is a collagen suspension containing polymethylmethacrylate (PMMA) microspheres, with a trace amount of lidocaine. The collagen is sourced from bovine skin in Australia. The 0.1ml size is for allergy testing with a test needle, composed of bovine collagen solution. It is used for deep dermal injections to correct nasolabial folds or for subperiosteal implantation for rhinoplasty (nasal bone section). The PMMA component is non-degradable. - Medical sodium hyaluronate-hydroxypropyl methylcellulose gel containing polyvinyl alcohol microspheres: Mainly composed of sodium hyaluronate, hydroxypropyl methylcellulose, polyvinyl alcohol microspheres, and balanced salt solution. It is used for deep dermal and superficial subcutaneous injection to correct moderate to severe forehead wrinkles and nasolabial folds. The polyvinyl alcohol component is non-degradable.