An Overview of the Draft Guidelines for Writing IFUs of Medical Devices in China

The Centre for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA), China has recently issued a set of draft guidelines for Medical Device Instructions for Use (IFU). This initiative reflects NMPA’s dedication to improving the technical evaluation of IFUs for medical devices and offering extensive guidance to applicants on China medical device regulations.

Crafted after extensive industry surveys and internal discussions, the updated guidelines seek to standardize the technical assessment of medical device IFUs, supporting applicants in their documentation endeavors.

The guidelines outline the necessary information that should be included in the manual, such as the basic information, product specifications, instructions and use, safety precautions, troubleshooting steps, period of use date, and cleaning instructions to comply with China medical device regulations. The guidelines provide general information on all medical devices and do not include specific requirements for individual products.

Why are Standardized Medical Device IFUs Important?

In China, creating medical device instructions for use guidelines requires strict adherence to the “Regulations on the Management of Medical Device Instructions and Labels”. It is the registrant’s responsibility to provide accurate, reliable, and standardized information, supported by detailed research data. Compliance requirements include meeting special criteria under the product standards or guidelines.

Key Components of Medical Device IFUs

IFUs Medical Device Template

Product Names must comply with the naming rules for common names of medical devices, the guiding principles for naming common names of medical devices, and the naming rules for various professional disciplines. They must also be consistent with the authorized registration certificate.

Model Specifications of the product should be clearly indicated in the instruction manual. If an instruction manual contains various models and specifications, the differences between them should be clearly indicated (diagrams and/or tables are advised). For independent software and products, including software, the software release version number should be explicitly disclosed.

The Registrant or Filing Company's Basic Details and Contact Information should be provided, which include:

• Registrant/Filing Company Information:
  • Company name, address, and contact information.
  • After-sales service unit’s name.
  • For imported devices: agency name, address, and contact information.
• Production Enterprise Information:
  • Company name, address, and production address.
  • Contact information.
• If Production is Entrusted:
  • Entrusted enterprise’s name, domicile, and production address.
  • Production license details.
• Certificate Number, which is the medical device registration/filing certificate number and product technical requirements number must be provided.
• Product Information includes performance indicators, technical parameters, and technical features based on predicted user needs.
• Ensure Consistency with the product’s actual situation and study/R&D information.
• Pre-market Clinical Trial Information:
  • Provide direct evidence of clinical performance, efficacy, and safety.
  • Cover trial goals, design, subject population, sample size, assessment indicators, outcomes, and conclusions.
• In Vitro Diagnostic (IVD) Equipment Instructions:
  • Specify instrument parameters and intrinsic performance indicators.
  • Include calibration details, if required, with explanations for limitations of use.
• The Structural Content or Constituents of the Product should be disclosed, Where necessary, include the internal structure and component information essential for the intended user to correctly install, use, maintain, and care for the product along with pictorial representations.
• Contraindications for the product should be clearly indicated (if applicable), that is, if it is not recommended or permitted to be used for certain diseases, conditions, or certain groups of people (such as children, the elderly, pregnant and lactating women, and those with liver and renal failure).
  • Article 11 of the “Regulations on the Administration of IFU and Labels for Medical Devices” requires that the medical device IFU include the “dangers, warnings, and educational information required by the”
  • To strengthen the reminder effect of precautions, it is advisable to employ emphatic logos, formats, typefaces, colours, and so forth.
  • The medical device IFU should notify the user of any residual dangers that may exist during use. Risks that remain unacceptable after implementing risk reduction measures should be highlighted.
• The Medical Device IFU Template should include information that allows the user and/or patient to fully comprehend the medical device’s warnings, precautions, actions to be done, and restrictions, and may include (if applicable):
  • Device Failure or Changes: Warnings and precautions for device failure or functional changes affecting device safety.
  • External Influences and Conditions: Warnings, precautions, and actions with respect to exposure to external influences or environmental conditions.
  • Interference Risks: Detail warnings and measures for foreseeable interference risks during specific diagnostic, research, or treatment activities.
  • Material-related Precautions: Precautions regarding materials, including carcinogenic, mutagenic, toxic, or allergenic properties.
  • Infectious Substances: Precautions related to potentially infectious substances present in the medical device.

An In-depth Look into Medical Device IFUs

• Specialized aspects of product use, such as equipment installation or calibration, requiring professional assistance should be clearly stated.
• Preparatory operations, including sterilization, identification of additional equipment, final assembly, and calibration, must be detailed.
• For devices with diagnostic functions, instructions should elaborate on the roles of indicators and controllers.
• Treatment products with varying parameters should provide instructions on dose-effect relationships and related precautions. IVD device instructions must cover test procedures, required software, and reference databases.
• Software instructions should detail functions, restrictions, data types, hardware requirements, and any other relevant information.

For devices using Artificial Intelligence (AI), instructions must clarify algorithm evaluation, clinical summaries, and indicator definitions.

• Labeling, if applicable, should include recommended quality control procedures with usage details and interpretations.
• Guidance on interpreting quality control results and actions to take, if control measures are ineffective, should be provided.
• Instructions for devices used with other devices/ drugs should outline usage methods, precautions, and interoperability details.
• Where relevant, medical device IFUs should provide information that can be used to verify that the device was correctly installed and can perform safely for its intended application. Such information would include:
  • Detailed information and the frequency of preventive and scheduled maintenance.
  • Cleaning and disinfection methods.
  • Component identification and replacement methods.
  • Necessary calibration information.
  • Methods for mitigating risks encountered during cleaning, installation, calibration, or repair.

If the medical device needs to be sterilized prior to use, the instructions should include cleaning, disinfection, packaging, and sterilization processes, as well as the number of reuses or other limitations.

• Storage and transportation instructions should specify the permissible environmental conditions for storage and transit (such as upper and lower temperature limits, light, and humidity) as well as any additional precautions (such as early unpacking if environmental requirements are not fulfilled, and so on).
• To avoid variations in storage conditions due to geographical changes, vague condition recommendations (such as room temperature, normal temperature, cold and dry) should be avoided.
• If the shipping and storage conditions of various product compositions differ, they should be specified separately.
• Separate storage conditions should be provided before and after opening the box.
• The period of use date must express the duration of use in terms of time, number of uses, or converted time, depending on clinical utilization:
• Include service life as well as environmental and other affecting elements (if applicable).
• Describe repairs and maintenance.
• Include ways for replacing replaceable parts.
• For displaying production and expiration dates, use the “see label” approach.
• Include the shelf life of single-use items.
• Provide a distinct shelf life, if stability varies before and after opening.
• A list of accessories, with replacement intervals and replacement instructions, should be provided.
• The label explanation includes explanations for graphics, symbols, abbreviations, etc., which are used in medical device labels.
• The date of preparation or revision of the instructions should be clearly stated.
• The following additional information can be included:
• Bibliography or reference literature.
• Content not suitable for other columns, based on product characteristics and risk analysis.
• Functional principles, if required.
• Relevant medical laws, regulations, and standards.
• In Vitro Diagnostic IVD equipment should describe detection principles, such as biological, chemical, microbiological, and immunochemical principles. Ensure sufficient information for users to understand device functions without disclosing proprietary information.

Overall, understanding the Regulatory requirements for medical device IFUs is crucial for creating high-quality, standardized instructions that are safe and effective for users. To ensure compliance with China medical device regulations for IFUs and labels, contact Freyr. We will provide you with expert support in navigating Regulatory requirements and ensuring accuracy and safety.