Class I medical device require only file filling in China, similar to listing of class I MD at FDA. However, a bit more documents are needed:

• Declaration of Conformity and EC certificate (EU)/ CFG (US)

• ISO 13485 certificate

• Instruction for use (IFU) and label (EN and CH)

• Risk management file (EN and CH)

• Simplified CER

• Chinese declaration of conformity of standards

The documents are almost same for change registration. Just additional descriptions and supporting documents of new changes are to submit. There is no extension registration due to fact that the certificate of class I MD doesn’t expire.

Please have a check of prerequisite of product registration of medical device at NMPA in China. The documents are mainly made of:

• Declaration of Conformity and EC certificate (EU)/ CFG (US)

• ISO 13485 certificate

• Essential safety and effectiveness requirements (CH)

• Instruction for use (IFU) and label (EN and CH)

• Risk management file (EN and CH)

• Clinical Evaluation (EN and CH)

• Chinese declaration of conformity of standards

• Test report of IEC 60601 series and biocompatibility report if applicable

• Product technical requirement and type testing report

The documents below mentioned refer to change registration in significant modification matter.

Pre-conditional documents

• Copy of NMPA certificate and PTR

• Change notification of former change registration

Basic document

The focus of documents (risk management file, clinical evaluation) is on the product modification (or called change) which triggers this regisration.

• Declaration of Conformity and EC certificate (EU)/ CFG (US)

• ISO 13485 certificate

• Essential safety and effectiveness requirements (CH)

• Statement of product modification and supportive documents with comparison table

• IFU and label (EN and CH)

• Risk management file (EN and CH)

• Clinical Evaluation (EN and CH)

• Chinese declaration of conformity of standards

• Test report of IEC 60601 series and biocompatibility report if applicable

• Product technical requirement and type testing report

The documents for extension registration should be prepared as early as possible, and be submitted to NMPA latest 6 months ahead of expiration time of NMPA certificate which is 5 years valid.

Pre-conditional documents

• Former NMPA certificate and PTR (with stamp)

• Change notification of each change registration

Basic document

•Statement of no-Change of product

•Chinese declaration of conformity of standards

•IFU and label (EN and CH)

•Former type testing report as reference (optional)