Chapter 2: Product Summary (综述资料)

NMPA Reference: Notice 2021-121, Attachment 5, Chapter 2
Document Code: NMPA-CH2
Responsible Party: Manufacturer (CRO assists)

Requirements Checklist

2.1 Table of Contents

• [ ] All headings and sub-headings with page numbers

2.2 Product Overview (概述)

• [ ] Generic name (通用名称) and basis for name selection
• [ ] Management classification: sub-category name, primary product category, secondary product category, management class (I/II/III), classification code
• [ ] Intended use summary
• [ ] Background information and development history (if applicable)
• [ ] Relationship to previously approved products (if applicable)

2.3 Product Description (产品描述)

2.3.1 Device and Operating Principle Description

For passive (non-active) devices:

• [ ] Working principle and mechanism of action (if applicable)
• [ ] Structure and composition
• [ ] Raw materials (all materials in direct/indirect contact with user or patient)
  • [ ] For biological materials: source, raw material, intended purpose, primary mode of action
  • [ ] For drug-device combinations: drug name, purpose, mode of action, source
• [ ] Delivery state and sterilisation method (if applicable): steriliser, method, shelf-life
• [ ] Structural diagrams and/or product illustrations
• [ ] Instructions for use with illustrations (if applicable)
• [ ] Distinguishing features from similar products

For active (powered) devices:

• [ ] Working principle and mechanism of action (if applicable)
• [ ] Structure and composition
• [ ] Main functions and component functions (key components, software, etc.)
• [ ] Product illustrations (labels, interfaces, control panels, applied parts)
• [ ] Distinguishing features from similar products
• [ ] For multi-component devices: connection/assembly relationships

2.3.2 Models and Specifications

• [ ] Comparison table or annotated illustrations for all variants
• [ ] Differences in structure/composition (or configuration)
• [ ] Differences in functions, features, operating modes
• [ ] Differences in technical parameters

2.3.3 Packaging Information

• [ ] Packaging information for all product components
• [ ] For sterile devices: sterile barrier system details
• [ ] For devices with microbial limits: packaging maintaining microbial limits
• [ ] How end-user can verify package integrity
• [ ] User-side packaging requirements before sterilisation (if applicable): materials, composition, dimensions

2.3.4 Development History

• [ ] R&D background and objectives
• [ ] Reference to similar/predicate products and rationale for selection

2.3.5 Comparison with Similar and/or Previous-Generation Products

• [ ] Comparison table covering:
  • Working principle
  • Structure and composition
  • Manufacturing materials
  • Performance indicators
  • Mode of action (implant, intervention, etc.)
  • Intended use
• [ ] Highlight similarities and differences

2.4 Intended Use and Contraindications

Intended Use

• [ ] Therapeutic or diagnostic function description
• [ ] Medical process description (in vitro/in vivo diagnosis, rehabilitation, monitoring, contraception, disinfection, etc.)
• [ ] Diseases, conditions to be diagnosed/treated/prevented/alleviated/cured
• [ ] Parameters to be monitored
• [ ] Intended use stage (post-treatment monitoring, rehabilitation, etc.)
• [ ] Target users and required skills/knowledge/training
• [ ] Single-use or reusable declaration
• [ ] Combination-use products required for intended purpose

Intended Use Environment

• [ ] Use location: hospital, laboratory, ambulance, home, etc.
• [ ] Environmental conditions: temperature, humidity, pressure, movement, vibration, altitude

Target Patient Population

• [ ] Patient population: adults, neonates, infants, children, or general declaration
• [ ] Patient selection criteria and monitoring parameters
• [ ] For paediatric devices: specific paediatric population description

Contraindications

• [ ] Risk/benefit-based contraindication list
• [ ] Specific populations: children, elderly, pregnant/lactating women, hepatic/renal impairment

2.5 Market History (申报产品上市历史)

• [ ] Market approval dates and sales status by country/region
• [ ] Differences between markets (design, labels, technical parameters)
• [ ] Adverse event summary table: date, description, actions taken, reporting status
• [ ] Recall summary table: date, description, actions taken
• [ ] Analysis and evaluation of adverse events/recalls with impact on safety/efficacy
• [ ] 5-year sales volume by country/region
• [ ] Adverse event rate = adverse events / sales volume x 100%
• [ ] Recall rate = recalls / sales volume x 100%
• [ ] Calculation methodology explanation

2.6 Other Information

• [ ] Detailed information on combination-use products
• [ ] For approved components/accessories: registration certificate numbers and NMPA website links

Comparison with EU MDR

Aspect	NMPA Ch.2	EU MDR Annex II Section 1
Device description depth	Distinguishes passive/active with specific requirements	Unified description approach
Market history	Mandatory adverse event/recall rates	Not required in TD
Classification	Chinese classification system (3-class, 22 categories)	Rule-based (Annex VIII)
Comparison with similar	Detailed tabular comparison required	Equivalence assessment in CER
Contraindications	Explicit section required	Covered in IFU/labelling

Key Standards & References

• Notice 2021-121, Attachment 5, Chapter 2
• Medical Device Classification Catalogue (2017 Edition, as amended)
• GB/T 16886 series: Biological evaluation (ISO 10993 adoption)
• Product naming rules per NMPA regulations