NMPA Communication and Pre-Submission Consultation

1. Key takeaways

Communication with the technical reviewer is a statutory mechanism, not an informal courtesy, and its value is removing directional disagreement before the file is fixed.

• Communication is a legal system. Article 22 of Order 47 (promulgated 26 August 2021, effective 1 October 2021) requires technical bodies to establish a communication system, and Article 23 provides for expert consultation.
• Pre-acceptance consultation pays off by avoiding a correction round. Directional disagreement that reaches formal review emerges as a deficiency, and deficiencies are notified in full at one time with a one-year window before review terminates.
• The right topics are questions of pathway judgment: choice of clinical evaluation route, technical requirement indicators, applicability of the innovation or priority channel, and registration unit division.
• The wrong topics are questions the text already answers. Submitting matters that can be settled from the statute dilutes the value of the discussion.
• Conclusions do not replace the application file. Feedback is not an approval decision and carries no promise about the outcome.
• Sequence matters against other pre-procedures: classification confirmation (Article 23 of Decree 739, 20 working days), innovative device special review (before the first application), and trial approval (Articles 38 to 40).

2. Legal basis

Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 14: seven categories of registration and filing material, the fourth being clinical evaluation material.
• Article 17(2): application material is passed to the technical review body within three working days of acceptance.
• Article 23(2): a classification confirmation request is decided and notified within 20 working days of acceptance.
• Article 27: a Class III high-risk trial approval is decided within 60 working days of acceptance, with silence treated as consent.

Provisions for the Administration of Medical Device Registration and Filing (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 10: special approval for innovative devices and priority approval for devices in urgent clinical need.
• Article 20: application of the classification rules and catalogue.
• Article 22: technical bodies shall establish a communication system.
• Article 23: the expert consultation system.
• Article 30: testing against the technical requirements before a trial, filing or registration.
• Article 38: listed Class III devices require approval and conduct in qualified Grade 3A hospitals.
• Article 41: deficiencies notified in full at one time, answered within one year, otherwise review is terminated and approval refused.
• Article 79: substantive changes require a variation; other changes are filed within 30 days.

Normative and technical documents

• Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of 2018, published 2 November 2018, effective 1 December 2018), including early intervention and a dedicated reviewer.
• Priority Review Catalogue of High-End Medical Devices (2025 edition), published in 2025.
• Announcement on Measures to Optimise Whole-Life-Cycle Supervision and Support High-End Device Innovation (No. 63 of 2025, issued 27 June 2025).
• Fees: domestic Class III initial registration RMB 153,600, variation RMB 50,400, renewal RMB 40,800.

Practical estimate. No official figure exists for how a request is submitted, the feedback cycle, the topic scope, or provincial Class II fees. Some provinces publish RMB 40,670 per registration unit; practice follows current published requirements.

3. Expert insights

Articles 22 and 23 are two systems with different uses. They sit in separate articles because they do different work.

Companies tend to know only one. Pathway questions move faster through communication, while technical disputes fit expert consultation; the wrong route gets the topic returned or the feedback generalised.

The gain from pre-acceptance consultation is avoiding a correction round, not shortening a deadline. Communication does not enter the review clock, so the benefit is indirect. Comparing the two on one cost table makes the point.

The third and fifth rows carry the weight. In correction the reviewer sets the topics and the file is fixed, so an adjustment often pulls in technical requirements, test reports and even clinical evaluation material. Before acceptance the company sets the topics while the file can move.

Sort the topic list into suitable and unsuitable.

Topic quality determines feedback quality: three to five substantive topics yield more than a list of fifteen, which attracts general answers.

Preparation should be topic-based, written and done in one go. Each topic should be phrased as a question that can be answered, with a preliminary view and its basis attached rather than an open invitation. The submission should be in writing, covering the product overview, the technical solution, the intended compliance route, and the list of statutes and guidance already consulted. Related topics belong in a single session, because splitting them produces inconsistent positions across rounds that formal review can later trace.

Communication interacts with three pre-procedures.

Two sequencing errors are common: asking about a route before the class is confirmed, so the answer lapses; and pushing the file down the routine route before special review, missing the filing point.

Place the legal status of the outcome correctly. Feedback is the technical body opinion based on the material submitted at the time. It is a technical communication opinion, not an approval decision. Two consequences follow: formal review rests on the complete file, and the opinion promises nothing about the result; and if the product plan changes materially after the discussion, the earlier opinion no longer applies. Records should be version-controlled, capturing the date, material version, feedback and later changes.

4. Practical recommendations

• Grade the questions into pathway, technical detail and format, submitting only the first two.
• Focus each session on three to five substantive topics, each with a preliminary view and basis.
• Complete the pre-procedures first, so pathway questions follow classification confirmation and the special review decision.
• Standardise the submission pack with product overview, technical solution, compliance route and a list of guidance consulted.
• Version-control the record, covering date, material version, feedback and later changes.
• Separate the two routes, using Article 22 for technical questions and Article 23 where expert argument is needed.
• Plan corrections from the one-year limit, tracking material, owner, source and days weekly.

5. Verification checklist

• □ The difference between communication (Article 22) and expert consultation (Article 23) is applied.
• □ Questions are graded, with only pathway and technical items submitted.
• □ Each session carries three to five topics, each with a preliminary view.
• □ The submission pack includes overview, technical solution, route and guidance list.
• □ The class is confirmed, or decided within 20 working days (Article 23(2)).
• □ The special review filing point has been assessed against the first application (Announcement No. 83).
• □ Priority catalogue entry has been confirmed before acceptance (Article 10; 2025 catalogue).
• □ Site requirements for catalogue products are confirmed (Article 38, Grade 3A).
• □ The record is version-controlled, and the opinion is not treated as an approval decision.
• □ The response plan follows the one-year limit (Article 41).
• □ Fees follow RMB 153,600 initial, RMB 50,400 variation and RMB 40,800 renewal, with Class II verified provincially.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages NMPA Class II/III registrations and filing procedures, coordinates typetesting, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com