Chapter 5: IFU & Labels (产品说明书和标签样稿)

NMPA Reference: Notice 2021-121, Attachment 5, Chapter 5
Document Code: NMPA-CH5
Responsible Party: Manufacturer (CRO reviews for regulatory compliance)

Requirements Checklist

5.1 Table of Contents

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

5.2 Instructions for Use (产品说明书)

• [ ] Content complies with "Regulations on Medical Device Instructions for Use and Labels" (医疗器械说明书和标签管理规定)
• [ ] Content complies with applicable regulations, rules, normative documents, and mandatory standards
• [ ] For imported devices: provide original language IFU

Key IFU content requirements (per Medical Device IFU & Label Regulations):

• [ ] Product name (matching registration certificate)
• [ ] Registrant/filer name, residence, contact information
• [ ] For imported devices: agent name, residence, contact information
• [ ] Production enterprise name, residence, production address, contact information
• [ ] Registration/filing certificate number
• [ ] Product technical requirement number
• [ ] Product description: structure, composition, working principle, intended use
• [ ] Scope of application, indications, contraindications, warnings, precautions
• [ ] Installation and use instructions (with diagrams if necessary)
• [ ] Product performance, main specifications, technical parameters
• [ ] Product maintenance, care information
• [ ] Storage and transport conditions
• [ ] Shelf life or use-by date
• [ ] Accessories list
• [ ] For single-use devices: clear single-use declaration
• [ ] Explanation of label symbols
• [ ] Manufacturer's post-market monitoring contact information

5.3 Label Samples (标签样稿)

• [ ] Minimum sales unit label sample
• [ ] Content complies with IFU & Label Regulations and mandatory standards
• [ ] Product name consistent with IFU and registration certificate
• [ ] UDI barcode/carrier (if applicable)
• [ ] Sterilisation status indication (if applicable)
• [ ] Lot number / serial number location
• [ ] Manufacturing date and expiry date format

5.4 Other Materials

• [ ] Supplementary documents for product information (if applicable)

Comparison with EU MDR

Aspect	NMPA Ch.5	EU MDR Annex II Section 2
IFU regulation	Dedicated IFU & Label regulation	Annex I Chapter III GSPR 23
Language	Chinese mandatory	Official language(s) of Member State
Original language IFU	Required for imported devices	Not specifically required in TD
Label standards	GB/T 15223 series (ISO 15223 adoption)	EN ISO 15223-1
e-IFU	Not yet widely adopted	Regulation (EU) 207/2012
Review depth	IFU is a core review document	IFU reviewed as part of TD

Key Standards & References

• Regulations on Medical Device Instructions for Use and Labels (Order No. 6, 2014)
• Notice 2021-121, Attachment 5, Chapter 5
• GB/T 15223 series: Medical device symbols (ISO 15223 adoption)
• YY/T 0466 series: Information supplied with medical devices (ISO 20417 adoption)
• Applicable mandatory GB/YY standards for specific device categories