Preamble

The purpose of this guideline is to guide the registration applicant to standardize the development process of Imaging system of positron emission and magnetic resonance imaging (hereinafter referred to as PET/MR) (hereinafter referred to as PET/MR) and to prepare the relevant medical device registration notification information. This guideline is a reference for the technical review department of PET/MR.

This guideline is a general requirement for PET/MR system, the registration applicant should determine whether the content is applicable according to the specific characteristics of the product. If not applicable, need to specify the reasons and the corresponding scientific basis, and based on the specific characteristics of the product to enrich and refine the content of the registration information.

This guideline is for registration applicants and technical reviewers to use the guiding documents, but does not include the administrative matters involved in the review and approval, and not as a mandatory implementation of regulations, should be used under the premise of complying with the relevant laws and regulations of this guideline. If there are other methods that can meet the requirements of the relevant regulations, they can also be used, but need to provide detailed research information and validation information.

This guideline is formulated under the current regulations and standards and the current level of knowledge, with the continuous improvement of regulations and standards, as well as the continuous development of science and technology, the relevant content will be adjusted in due course.

Scope of application

This guideline is applicable to PET/MR system, which can be divided into split type, PET insert type and fully integrated type according to the different forms of product structure, the PET/MR system referred to in this guideline is the fully integrated/one-piece PET/MR, and the split type and insert type PET/MR system can refer to this guideline.

KeyPoints for Registration Review

Regulatory Information

1. Classification code and management category

Referring to the current Classification Catalog of Medical Devices, the classification code of this type of product is 06-17-03, and the management category is Class III.

2.Registration unit division

If the declared product exists multiple model specifications or configurations, it is recommended to divide the registration unit based on the product scope of application, technical principles, structural composition, performance indicators and other key elements.

2.1 Systems with different scope of application are divided into different registration units.

For example, head-specific PET/MR and whole-body application PET/MR should be divided into different registration units.

2.2 PET part

The main components, design and structure of the equipment with large differences should be divided into different registration units.

For example, devices with different crystal materials and different detector structures/combinations shall be divided into different registration units.

Devices with different number of detector rings should be divided into different registered units.

Hardware with large differences that have a large impact on system performance should be divided into different registration units.

In principle, when PET is divided into different registration units, PET/MR should also be divided into different registration units.

2.3 MR Part

Referring to the MR guideline, in principle, when MR is divided into different registration units, PET/MR should also be divided into different registration units.

Product risk management information

Product risk management information should be in accordance with GB/T 42062 "Application of Medical Device Risk Management to Medical Devices". The applicant is required to identify and determine the hazards (sources) related to the product, estimate and evaluate the related risks, control the risks and monitor the safety and effectiveness of risk control. This guidance provides a non-exhaustive list of examples of possible hazards (sources) for PET/MR systems (Annex 2) to assist applicants in determining the hazards (sources) associated with the product. The applicant can identify other possible hazards (sources) based on product characteristics and take appropriate control measures to ensure that the product risk is reduced to an acceptable level.

2. List of basic principles of medical device safety and performance

The applicant is required to provide "List of basic principles of medical device safety and performance", and explain the product in order to comply with the applicable requirements of the methods used, as well as documents to prove its compliance. For the inapplicable requirements, should explain the reasons.

3. Product technical requirements and inspection reports

Clinical evaluation

PET/MR products are not exempted from clinical evaluation of medical devices, clinical evaluation information can refer to the "Technical Guidelines for the Clinical Evaluation of Medical Devices" "Quality Management Standards for Clinical Trials of Medical Devices" "Guidelines for the Design of Clinical Trials of Medical Devices" "Acceptance of Medical Devices Overseas Clinical Trial Data Technical Guidelines" "Positron Emission/X-Ray Computed Tomography System Clinical Evaluation Guidelines for the Same Species" and "Guidelines for Registration Review of Clinical Evaluations of Medical Devices". Positron Emission/X-Ray Computed Tomography System Clinical Evaluation of the Same Species" and "Guidelines for Technical Review of Clinical Evaluation of Medical Magnetic Resonance Imaging Systems of the Same Species (2020 Revision)" and other documents to submit relevant information.

Product specification and labeling samples
Product specifications and labels should comply with the "Regulations for the Administration of Medical Device Specifications and Labels" and the requirements of relevant national standards and industry standards (e.g., GB 9706 series of safety standards, YY 9706.102, etc. on the instructions and labeling requirements). Among the instructions should pay special attention to the following places:
Product instructions need to clarify the product's daily maintenance and quality control methods. Clearly defined equipment maintenance cycle, schedule quality control procedures, quality control testing methods and judgment standards.
If there is a combination of equipment used in conjunction with the declared product (such as respiratory gating equipment), the manufacturer of the combination of equipment needs to be clear in the instructions, model and connection with the declared product and the use of methods.
Product specifications recommended to provide the main product technical parameters in line with the relevant standards, including the main performance indicators specified in the product technical requirements.