Technical Documents for Chinese Registration
Submission Dossiers, all in Chinese!
In General
The document submitted to authority NMPA is prepared in term of submission dossier. Since Nov. 2019 the documents for class II and III in all types of registration must be submitted through eRPS. The structure of submission dossier bases on the table of content at international medical device regulators forum (IMDRF).
The manufacturer has to adjust the contents mainly from the original
technical documentation into Chinese templates fulfilling the Chinese regulatory requirements.
We just outline the basic documents for an overview below. All
original certificates and
English documents have to be
signed. The most original statements and certificates as (Declaration of Conformity and EC certificate in EU/ certificate to foreign government
(CFG) in US and ISO 13485 certificate)
in CH 1 as well as label and instruction for use in CH 5 (s. eRPS structure) must be additonally
legalized. The legalization is not needed for preclinical test report as 60601 series. All
statement letters and declaration of conformity must be
signed and stamped by legal manufacturers.
Document menu
1. Class I Medical device
-
Initial RegistrationListenelement 1
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
-
Change RegistrationListenelement 2
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.
2. Class II and III medical device
-
Initial RegistrationListenelement 1
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
-
Change RegistrationListenelement 2
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
-
Extension RegistrationListenelement 3
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)
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