China Medical Device IFU Draft Guidelines have been released by the National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE). This move is part of the NMPA’s commitment to enhancing the technical evaluation of medical device instructions for use (IFU) and providing comprehensive guidance to applicants.
The revised guidelines, shaped through industry surveys and internal consultations, aim to standardize the technical review of medical device instructions for use and assist applicants in their documentation efforts. The consultation period is open until December 1, 2023.
Key Highlights of China Medical Device IFU Draft Guidelines:
Introduction: The guidelines for preparing medical device instructions for use aim to enhance the standardization and scientific rigor of the technical review of medical devices. Aligned with relevant regulations and administrative measures, the guidelines provide a framework for registrants and filing entities to create accurate and standardized instructions for use.
1. Scope of Application: The guidelines are applicable to medical device IFU inserts seeking registration or notification, excluding in vitro diagnostic reagents. While offering general requirements, the guidelines stress the importance of tailoring IFUs based on specific products, leaving room for refinement by relevant authorities.
2. General Requirements: The medical device registrant bears primary responsibility for IFU preparation, ensuring the provision of accurate, truthful, and standardized information. The guidelines emphasize adherence to the Regulations on the Administration of Medical Device Instructions and Labels, specifying requirements from relevant articles. Standardization, clarity, and user-friendliness are highlighted, with product-specific standards considered if available.
3. Main Content of China Medical Device IFU Preparation: The IFU should encompass various content sections, including product name, model, registrant information, product performance, structural composition, scope of application, contraindications, precautions, warnings, and reminders. The inclusion of clinical trial information and specific details for in vitro diagnostic devices is emphasized.
4. Installation and Use: Detailed instructions for installation and use are crucial, covering facility requirements, user qualifications, preparatory steps, and diagnostic or measurement functions. Special emphasis is placed on products for consumer personal use, highlighting the need for clear, understandable instructions for both professional and non-professional users.
5. Maintenance and Upkeep: The guidelines outline the inclusion of information to ensure proper maintenance, including preventive measures, cleaning, disinfection, component identification, calibration, and risk mitigation during these processes. For sterilizable devices, detailed sterilization methods and reuse restrictions are essential.
6. Storage and Transportation: Instructions For Use should provide environmental conditions for storage and transportation, specifying temperature limits and precautions. Different conditions for various product compositions and stability information post-opening are emphasized.
7. Period of Use: Manufacture and expiration dates, service life, and replacement part information should be clearly communicated. For single-use products, shelf life must be indicated, aligning with specific product guidelines.
8. Accessories and Label Interpretation: A comprehensive list of accessories with replacement cycles and instructions for replacement methods is required. Additionally, clear explanations of graphics, symbols, and abbreviations on the medical device label are essential.
9. Instructions for Patients: For devices used by non-professional users, patient instructions should be provided, covering device identification, use instructions, expected performance, adverse events, and necessary precautions. Specific considerations for patient information booklets and patient identification cards are outlined in the case of implant.
10. Instructions for Customized Medical Devices: Instructions for customized medical devices must adhere to regulations, including a unique identification number, patient information, and details about the issuing medical institution and attending physician.
11. Date of Preparation, Revision and Other: The date of manual preparation or revision should be included. The manual may also include additional information based on product characteristics and risk analysis, such as functional principles and legal requirements outside the medical device regulatory system such as laws related to consumer protection, industry-specific regulations, and standards. While these are essential considerations, they may not be the primary focus of medical device supervision.
In conclusion, these guidelines offer a comprehensive framework for the preparation of medical device instructions, emphasizing standardization, clarity, and adherence to regulatory requirements. Registrants and filing entities must consider product-specific standards and guidelines, ensuring that instructions cater to the intended audience, whether professional or non-professional users.
How to submit comments
If you would like to submit any comments, suggestions or feedback on the draft guidelines, please email Xiaoyin Liu at liuxy1@cmde.org.cn before December 1, 2023.
Further information
Read the original NMPA proposed China Medical Device IFU Draft Guidelines in full. Discover our services for medical device registration, renewals and NMPA Legal Agent.
