Drugdu.com expert's response:

When undertaking medical device registration for the first time, particular attention should be paid to the following aspects to ensure compliance with the process and enhance the approval rate:

I. Clarify Product Classification to Avoid Misclassification

Classification Basis: Accurately determine the management category (Class I, II, or III) based on the "Medical Device Classification Rules," considering dimensions such as product intended use, structural features, and form of use.

Class I: Subject to filing management, with no requirement for clinical trials.

Classes II and III: Require registration application. Class III and certain high-risk Class II products typically necessitate clinical trial support.
Common Pitfalls: Misclassifying Class II products as Class I, leading to non-compliance in subsequent document submissions.
Solutions:

Strengthen scientific analysis of product functions, mechanisms of action, and risk levels.

Seek consultation from professional institutions or regulatory authorities when necessary, utilizing the latest regulations and guidance documents to accurately define the category.

II. Prepare Complete and Standardized Application Materials

Core Material Checklist:

Medical Device Registration Application Form: Detailed information on the product, applicant, and agent.

Product Technical Requirements: Clearly define performance indicators and testing methods, ensuring operability.

Product Instructions and Labels: Follow the specified format, ensuring accurate information and clear, secure labeling.

Product Registration Inspection Report: Issued by a qualified testing institution, covering all performance indicators and within the validity period.

Clinical Evaluation Data: Depending on the risk level, may require submission of clinical trial data or clinical data from similar products.

Quality Management System Certification: Such as ISO 13485 certification, proving the enterprise's capability to produce high-quality medical devices.

Enterprise Business License: Ensure the qualification certificate is valid and the product falls within the scope of the production license.
Other Potentially Required Documents:

Agency agreements, authorization letters, production site proof documents (property certificates or lease agreements), site layout plans, and main production workshop layout diagrams.
Notes:

Ensure materials are authentic, accurate, and comply with regulations such as the "Medical Device Supervision and Administration Regulations" and "Medical Device Registration Management Measures."

Standardize formats, including chapter outlines and page numbering, to facilitate review.

III. Emphasize Technical Evaluation and Clinical Trials

Technical Evaluation: Covers aspects such as product safety, effectiveness, and quality control. Ensure product design, manufacturing processes, and raw materials meet technical requirements and standards.

Clinical Trials: Applicable Scenarios: High-risk or highly innovative products (e.g., Class III medical devices).

Design Requirements: The trial protocol must be reasonable, scientific, with adequate sample size to demonstrate product safety and effectiveness.

Result Requirements: Must be authentic and reliable, providing strong evidence for product safety and effectiveness.

Solutions: Choose an appropriate clinical evaluation pathway based on the product's risk level (e.g., exemption from clinical trials, comparison with similar products). Scientifically design the clinical trial protocol and, if necessary, utilize previous clinical data to supplement the review, reducing unnecessary trials.

IV. Establish and Operate an Effective Quality Management System

Core Requirements: Based on the "Medical Device Production Quality Management Standards," refine system documentation and operational procedures.Ensure the system operates stably and covers all registered products.

Common Issues:Disconnect between system documentation and actual operations, or failure to cover all products. 

Solutions: Conduct regular internal audits to ensure consistency between hardware facilities, documentation records, and application materials. Introduce professional technical transfer and project management personnel to enhance system operational efficiency.

V. Strengthen Communication with Regulatory Authorities

Communication Content: Stay informed about registration progress and existing issues to take timely corrective actions. During expert review sessions, provide comprehensive materials and explanations, engaging effectively with the expert committee.

Communication Methods: Regularly participate in training and policy briefings organized by regulatory authorities. Hire experienced registration agents to assist in accurately understanding and applying regulations.

VI. Monitor Timeliness and Change Management

Timeliness Requirements: Registration certificates are typically valid for 5 years, requiring renewal before expiration. Plan the registration cycle reasonably and closely monitor policy updates and approval progress.

Change Management: If significant changes (e.g., design, raw materials, manufacturing processes) occur after product registration, report to regulatory authorities, which may necessitate re-approval or re-filing.

VII. Protect Intellectual Property and Trade Secrets

Intellectual Property Protection: For innovative medical devices, promptly apply for patent protection to prevent technology infringement and unauthorized use.

Trade Secret Protection: Strengthen confidentiality measures for core technologies and commercial information to prevent leaks.

VIII. Enhance Personnel Competence and Training

Training Content: Regularly train employees on regulations, quality management systems, and product knowledge.

Training Objectives: Improve employees' compliance awareness and capabilities to ensure smooth product registration and management processes.