Essential Medical Device Registration Application Templates and Checklists

To help companies efficiently complete medical device registration applications, we have compiled comprehensive template files and checklists covering all key aspects of the application process.

Application Document Templates

Comprehensive Document Templates

Medical Device Registration Application Form Template

Applicable Scope: All types of medical device registration applications

Template Key Points:

• Standardized applicant basic information completion
• Product basic information description requirements
• Application item selection guidance
• Commitment letter signature requirements

Completion Notes:

1. Ensure all information matches business license
2. Product name should comply with naming rules
3. Application item selection must be accurate and complete
4. Legal representative signature must be authentic and valid

Applicant Qualification Certificate Document Checklist

• Business license copy
• Organization code certificate copy (if applicable)
• Legal representative identification
• Power of attorney (if applicable)
• Legal sales certificate for overseas enterprises (imported products)

Product Technical Requirements Template

Basic Format Requirements

Product Name: [Specific product name]
Model Specifications: [List all model specifications]
Performance Indicators: [Develop according to product characteristics]
Test Methods: [Reference relevant standards or self-established methods]

Performance Indicator Development Principles

1. Safety Indicators

   • Electrical safety requirements
   • Mechanical safety requirements
   • Biocompatibility requirements
   • Environmental adaptability requirements

2. Effectiveness Indicators

   • Functional performance parameters
   • Accuracy and precision requirements
   • Stability and reliability indicators
   • Service life specifications

3. Quality Control Indicators

   • Appearance and structure requirements
   • Identification and packaging requirements
   • Software function requirements (if applicable)

Risk Management Document Templates

Risk Management Report Structure

1. Risk Management Overview

   • Risk management process description
   • Risk management organizational structure
   • Risk acceptability criteria

2. Risk Analysis

   • Intended use and reasonably foreseeable misuse
   • Hazard identification
   • Risk estimation

3. Risk Control

   • Risk control measures
   • Residual risk assessment
   • Risk-benefit analysis

Risk Identification Checklist

Design Risks:

• Inappropriate material selection risk
• Structural design defect risk
• Human factors engineering risk
• Software defect risk

Manufacturing Risks:

• Production process control risk
• Raw material quality risk
• Environmental contamination risk
• Operational error risk

Usage Risks:

• Misuse and abuse risk
• Improper maintenance risk
• Environmental condition impact risk
• Insufficient user capability risk

Quality Management System Inspection Checklist

Management Responsibility Inspection Points

Quality Policy and Objectives

• Is quality policy clear and appropriate
• Are quality objectives measurable and achievable
• Are policies and objectives effectively communicated
• Is regular review and update mechanism established

Organizational Structure and Responsibilities

• Is organizational structure clear and reasonable
• Are responsibilities and authorities clearly defined
• Is management representative appointed and performing duties
• Is quality management system operating effectively

Resource Management Inspection Points

Human Resources

• Do personnel qualifications meet requirements
• Are training plans developed and implemented
• Is training effectiveness verified
• Are key positions adequately staffed

Infrastructure

• Do production facilities meet requirements
• Are production equipment appropriate and well-maintained
• Are inspection equipment calibrated and valid
• Does work environment meet product requirements

Work Environment

• Are cleanliness requirements met
• Is temperature and humidity control effective
• Are contamination prevention measures sufficient
• Are special environment requirements achieved

Product Realization Inspection Points

Design and Development

• Is design planning adequate
• Are design inputs complete and accurate
• Is design process controlled
• Do design outputs meet input requirements
• Are design reviews conducted as planned
• Are design verification and validation adequate
• Are design changes controlled

Procurement Process

• Is supplier evaluation and selection procedure established
• Is procurement information adequate and clear
• Is procurement product verification effective
• Is supplier performance monitoring implemented

Production and Service Provision

• Are production processes planned and controlled
• Are work instructions complete and effective
• Is production process monitoring adequate
• Are product identification and traceability established
• Is customer property properly protected
• Is product preservation appropriate

Clinical Evaluation Document Checklist

Clinical Evaluation Path Selection

Clinical Trial Exemption Condition Check

• Does product belong to exemption catalog
• Do similar medical devices exist
• Is the declared product substantially equivalent to similar products
• Is similar product clinical application safe and effective

Clinical Trial Necessity Assessment

• Product risk level assessment
• Existing clinical data adequacy assessment
• Domestic and international clinical application investigation
• Regulatory authority communication and exchange records

Clinical Trial Protocol Key Points

Trial Design

• Are research objectives clear
• Is trial design scientific and reasonable
• Are primary endpoint indicators appropriate
• Is sample size calculation adequate

Subject Protection

• Are inclusion and exclusion criteria reasonable
• Is informed consent form complete
• Is risk-benefit ratio acceptable
• Are adverse event handling procedures comprehensive

Registration Testing Preparation Checklist

Pre-testing Preparation

Testing Institution Selection

• Testing institution qualification confirmation
• Testing capability scope verification
• Testing timeline understanding
• Testing cost budgeting

Sample Preparation

• Are sample quantities sufficient
• Are sample specifications complete
• Are sample conditions good
• Are accompanying documents complete

Technical Document Preparation

• Product technical requirements
• Testing reference standards (if needed)
• Product instructions
• Related technical materials

Testing Process Cooperation

Testing Communication

• Testing plan confirmation
• Testing progress tracking
• Timely problem communication
• Supplementary material provision

Quality Control

• Testing process witnessing
• Abnormal situation recording
• Testing result confirmation
• Testing report review

Review Response Preparation Checklist

Review Opinion Response Preparation

Technical Issue Preparation

• Product technical principle explanation
• Key technical material supplementation
• Comparative study data preparation
• Expert opinion supporting materials

Clinical Issue Preparation

• Clinical data supplementary analysis
• Literature research result organization
• Clinical expert opinion consultation
• International clinical application evidence

Quality Management Issue Preparation

• Quality management system document updates
• Production site rectification plans
• Key control point strengthening measures
• Quality management personnel training

Communication and Exchange Preparation

Pre-meeting Preparation

• Meeting agenda organization
• Technical material preparation
• Expert team formation
• Meeting material production

Meeting Cooperation

• Accurate problem understanding
• Detailed technical question responses
• Clear regulatory requirement confirmation
• Follow-up work plan development

Usage Instructions

Template Usage Guidelines

Recommendations for using these templates and checklists:

1. Customize Based on Product Characteristics: Different product types require appropriate template adjustments
2. Combine with Latest Regulatory Requirements: Timely update template content to ensure compliance with latest regulatory requirements
3. Establish Internal Standards: Build enterprise internal standard templates based on general templates
4. Regular Review and Improvement: Continuously improve template quality based on usage experience and feedback

Professional Service Support

For more detailed guidance and customized services:

• Provide personalized template customization services
• Assist in establishing enterprise internal standard systems
• Provide professional training and guidance
• Track services to ensure application success

These templates and checklists are compiled based on extensive practical experience and can help companies significantly improve application efficiency and success rates while ensuring the standardization and completeness of application materials.