• Classify registration products and plan registration pathways;

• Systematically compile, organize, and submit registration documents in compliance with requirements;

• Conduct gap analysis and compliance review of registration dossiers;

• Communicate and coordinate with regulatory authorities, track review progress, and promptly respond to deficiency letters with technical revisions;

• Provide end-to-end follow-up for sample registration testing (if applicable);

• Support system on-site inspections (if applicable);

• Assist clients with filing, variations, transfers, cancellations, and other procedures;

• Post-approval management and supervision.

1. Definition and Background

Definition:

Domestic medical device registration refers to the statutory process where domestically manufactured or imported medical devices must submit technical documentation to the National Medical Products Administration (NMPA) or provincial medical device authorities for review and approval to obtain the Medical Device Registration Certificate before market entry.

Background:

·Regulatory Requirements:

Per the Regulations on the Supervision and Administration of Medical Devices (2021 revision), devices are classified by risk (Class I: filing; Class II/III: registration), with registration being the core process ensuring safety/efficacy.

·Industry Trends:

Emerging innovations (e.g., AI diagnostic software, wearables) drive alignment with international standards (e.g., IMDRF), enhancing lifecycle oversight.

2. Applicable Scope

1）Target Products:

·Device Classes:

·Class II (medium-risk, e.g., thermometers, blood pressure monitors) and Class III (high-risk, e.g., stents, artificial joints);

·IVDs (classified per IVD Catalog).

·Scenarios:

·First-time market entry;

·Major changes to registered devices (e.g., design, intended use, manufacturing process);

·Renewal before expiry (5-year validity).

2）Exclusions:

·Class I devices (low-risk, e.g., cotton swabs) subject to filing;

·R&D/clinical trial samples (require Medical Device Clinical Trial Approval).

3. Basic Requirements

Core Requirements:

1）Technical Documentation:

·Technical files: Product requirements, risk management (YY/T 0316), biological evaluation (GB/T 16886), software studies (algorithm validation).

·Clinical Evaluation:

Equivalent device comparison: Clinical data and gap analysis;

Clinical trials: Multicenter reports compliant with Medical Device GCP.

2）Quality Management System:

·Pass Medical Device GMP on-site audits;

·Submit QMS documents (design controls, production protocols, adverse event monitoring).

3）Product Testing:

·Full-performance testing by national/provincial labs (e.g., electrical safety, EMC);

·Compliance with mandatory standards (e.g., GB 9706.1 for medical electrical equipment safety).

4. Registration Process

1）Preparation:

·Product classification (submit to NMPA/provincial authorities);

·Clinical evaluation pathway (comparison or trials).

2）Document Preparation:

·Compile dossiers (technical requirements, clinical reports, labeling);

·Complete product testing (via accredited labs).

3）Submission:

·Submit electronically via NMPA’s eRPS system;

·Class II: Apply to provincial authorities; Class III: Apply to NMPA.

4）Technical Review & Supplements:

·Timeline: Class II (60 wording days), Class III (90 working days), excluding supplement time;

·Address deficiencies (e.g., insufficient clinical data, missing tests).

5）QMS Audit:

On-site inspections by authorities (if required).

6）Approval:

Issuance of Medical Device Registration Certificate (format: 国械注准2023XXXXXXX).

7）Post-Market:

·Renewal: Apply 6 months pre-expiry;

·Changes: Major changes require re-registration;

·Annual reports & adverse event reporting (via national monitoring system).

5. Regulatory Basis

Regulations on the Supervision and Administration of Medical Devices

Medical Device Registration and Filing Management Measures

IVD Registration and Filing Management Measures

Technical Guidelines for Medical Device Clinical Evaluation

Classification Guidelines for AI Medical Software

Cybersecurity Review Guidelines for Medical Devices

Special Scenarios:

Innovative Devices: Qualifying products under the Expedited Review for Innovative Medical Devices enjoy 30% faster review.

Imported Devices: Additional requirements: foreign marketing approval (e.g., FDA 510(k), CE) and QMS compliance statements.