The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
Table of content
The recently published guidance document provides an overview of the applicable regulatory requirements the parties involved should comply with, as well as additional clarifications and recommendations to be taken into consideration in order to ensure compliance with the existing legal framework.
General Provisions
This implementation guideline was developed to enhance the review process for innovative medical device applications under the special evaluation pathway. It aims to stimulate medical device research and innovation while promoting high-quality development within the industry. The rules are issued in accordance with the “Special Evaluation Procedure for Innovative Medical Devices” introduced to govern the respective relationship.
The guideline defines the scope of the special evaluation application review as a formal process, wherein expert panels are organized to assess the submitted applications and deliver informed opinions. The review process adopts an expert-review model, with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials being responsible for forming expert groups and conducting assessments.
To streamline and support this process, the National Medical Products Administration (NMPA) has established an Innovation Review Office within the Center for Medical Device Evaluation (CMDE). The office comprises personnel from the CMDE, the NMPA Medical Device Registration Department, and members from the aforementioned societies.
The Secretariat of this office is housed at CMDE and is responsible for the day-to-day operations, including organizing expert reviews, verifying the compliance of the review procedures, publicizing review outcomes, and informing applicants of the results via the CMDE website.
Innovation Application and Formal Review
According to the document, applicants who meet the criteria outlined in Article 2 of the Special Evaluation Procedure may submit a request for special review. Once submitted, the Secretariat of the Innovation Review Office conducts a formal examination of the materials provided.
This initial check ensures that documentation is complete and compliant. The requirements include a fully completed application form, proof of the enterprise’s legal qualifications, and supporting documents on intellectual property.
For intellectual property, applicants must demonstrate they either hold a valid Chinese invention patent granted within the past five years or possess licensed rights, with appropriate documentation to prove legal use. In cases where patents are only published but not yet granted, additional materials such as proof of novelty and inventive step, along with search reports from the patent authority, must be submitted.
Additionally, applicants are required to provide a comprehensive summary of the product’s R&D activities. This includes laboratory research, animal testing, and clinical trial results where applicable.
The summary should detail the product development process, encompassing design input, verification, and output stages.The application must also include technical documentation describing the product’s intended use, operating mechanism, and core performance indicators.
Proof of innovation is critical and may involve published academic papers, comparative analyses with existing products, or a narrative explaining the product’s novelty and significant clinical value. Risk assessments and draft instructions for use are also required.
Applicants should affirm the authenticity of all submitted materials via a signed declaration. Furthermore, the submission must clarify whether the product falls under medical device regulation and include preliminary review comments from provincial authorities.
When reapplying after a prior rejection, applicants must cite all previous acceptance numbers and decisions, along with documentation on how the product and the submission package have been revised. It is mandatory that the innovation application is filed prior to the initial product registration.
Expert Selection
The review process relies on the expert review system, which follows a group-leader responsibility model. Experts are randomly selected through a management system to ensure impartiality.
Eligible experts must meet strict requirements. They must adhere to national laws and ethical standards, be experienced professionals with senior-level technical titles or equivalent qualifications, and possess in-depth knowledge of both domestic and international developments in their respective fields.
Experts should also be well-versed in regulations related to medical devices and innovative products. To maintain procedural integrity, experts must be in good health and under 65 years old, though exceptions apply for high-profile specialists such as academicians.
It is explicitly stated that in order to protect fairness, individuals with conflicts of interest are disqualified. This includes those involved in the development of the product under review, individuals who have received gifts from applicants, and anyone employed by competing medical device firms.
Experts who have leaked confidential information or repeatedly failed to perform their duties are also excluded. Any expert who fails to disclose a conflict or refuses to recuse themselves when required will have their opinions voided.
Expert Review Procedure
After a submission passes formal review, the Innovation Review Office sends a request to the academic societies to convene an expert review meeting. Applications with false, inconsistent, or unclear documentation – or those whose intellectual property documentation is incomplete or unconvincing – are rejected at this stage.
Upon receiving the review request, the societies notify the applicant and request supplementary meeting materials, such as a presentation and video explaining the innovation. These materials must focus on core patented technologies, product maturity, originality, and clinical significance.
The preparation period for these materials does not count toward the review timeline. Applicants may choose to attend the expert meeting virtually. However, they are only allowed to participate in the Q&A session and are excluded from deliberative segments of the meeting.
During the meeting, rules and confidentiality terms are reiterated, and experts sign a pledge to comply. The meeting is chaired by the group leader. Experts review the application based on the Special Procedure and related guidance documents.
Each expert submits a written opinion on whether the application meets the criteria, which is then compiled into a group consensus report indicating approval or rejection. All participants are required to keep information confidential, including the identity of the reviewers and the details of the product under evaluation.
Following the expert meeting, the Innovation Review Office holds an internal administrative meeting to confirm the product name, classification, and procedural compliance. The final decision is then published on the CMDE website. Approved applications are publicly posted for 10 business days.
If the application is rejected, a communication meeting is arranged where the societies explain the review feedback to the applicant, aiming to guide them in refining their R&D direction. If the classification of the product as a medical device is uncertain, the application is denied until the issue is resolved.
Applicants may voluntarily withdraw at any stage by submitting a signed form with reasons for withdrawal.
Objection Handling
As explained in the document, two types of entities may raise objections: third parties who disagree with the approval of a publicly posted product and applicants who disagree with a rejection decision.
Objections from third parties must be submitted within the public comment period, while applicants must file theirs within one month of receiving the decision. Objections must be documented using the official “Objection Form”, signed by the objecting party, and limited to the original application and submission materials.
Upon receiving an objection, the academic societies conduct an internal review and may involve experts if technical issues arise. The Innovation Review Office validates the compliance of the review process and then informs the objecting party of the outcome.
Duplicate objections based on previously resolved matters will not be accepted.
Supplementary Provisions
For approved innovation applications, the CMDE arranges an initial communication meeting to understand product development progress, identify technical challenges, and align registration plans. During this meeting, the applicant must designate a primary contact person, who should be knowledgeable about regulatory requirements.
Any changes in this role must be promptly communicated to the CMDE. Applicants are also encouraged to submit communication requests via the eRPS platform before and during the registration process.
Communication meetings can be organized to address significant technical or safety issues, clinical trial designs, interim results, supplementary documentation, or other major concerns. Before submitting the final registration dossier, applicants are advised to request a concluding communication meeting.
During this meeting, they present the prepared registration documents, summarize previous discussions, and receive CMDE’s feedback. A formal meeting summary is signed by both parties and retained as a key reference for the upcoming technical evaluation.
Issues already addressed in earlier discussions will not be re-evaluated. Finally, the CMDE retains the authority to interpret these rules, which take effect immediately upon publication.
Conclusion
In summary, the present document provides an extensive overview of the applicable regulatory requirements, as well as additional clarifications to be considered by the parties interested in placing their products on the country’s market.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
