Three Medical Device Registration Review Guidelines Released

Registration Review Focus Areas

The review framework for these three device categories is essentially the same, covering six major parts: regulatory information, overview materials, non-clinical materials, clinical evaluation materials, instructions for use and label samples, and quality management system documents.

Regulatory Information

For meniscus suture systems and orthodontic anchorage screws, applicants need to clearly explain:

●Product name

●Classification code

●Registration unit division

Artificial cervical intervertebral disc prostheses require one additional layer of detail: model specifications, structure, and composition must also be described.

Overview Materials

For all three device categories, applicants should clearly explain:

●Product description

●Model specifications

●Packaging information

●Reference and comparison with similar and/or previous-generation products

●Scope of application and contraindications

●Marketing history of the submitted product

Meniscus suture systems and orthodontic anchorage screws also specifically emphasize operating principles and development history. Meniscus suture systems additionally include instruments used together with the product.

The logic is straightforward: it is not enough to describe the product itself. Applicants also need to explain how the product is used.

Non-clinical Materials

This section becomes more technical. All three device categories require:

●Product risk management materials

●Essential principles checklist for medical device safety and performance

●Product technical requirements

●Product testing

●Research materials

In general, this part is used to demonstrate device safety.

Clinical Evaluation Materials

This is where the three device categories differ the most. Meniscus suture systems and orthodontic anchorage screws are relatively conventional: substantial equivalence comparison and clinical trials.

Artificial cervical intervertebral disc prostheses are different. The requirements are more detailed, including:

●Clinical trial design type

●Inclusion and exclusion criteria

●Subject withdrawal criteria and handling of withdrawn subjects

●Clinical trial duration and visit windows

●Clinical trial endpoints and evaluation criteria

●Selection of control products

●Sample size estimation

●Demographic and baseline characteristics

●Statistical analysis methods

In other words, the question is no longer simply whether a clinical trial is needed. The framework for how to conduct the clinical trial has already been laid out.

The Other Two Major Sections

Instructions for use and label samples: all three guidelines clarify the role of the Provisions on the Administration of Medical Device Instructions and Labels and standards such as YY/T 0466.1. Quality management system documents should be prepared with reference to the announcement on medical device registration submission requirements and approval document formats.

Conclusion

The three newly released medical device guidelines share the same broad framework, while the artificial cervical intervertebral disc prosthesis has more specific requirements in the clinical evaluation section. The consultation notice also includes a feedback form, giving relevant companies and professionals a channel to participate in improving the guidelines and supporting smoother review work for these devices.