China Stand-Alone Medical Software

Specific Regulatory Requirements for SaMD

Stand-alone medical software is considered a medical device in China and can be classified as either Class II or Class III depending on the indications for use. For stand-alone medical software, AI has become a very popular trend. There are several Chinese domestic Al-based stand-alone software that got NMPA approval, but for import Al products, there are still some regulatory obstacles. It is difficult for foreign manufactures to collect patient information and establish the appropriate local database(s) in China. Manufacturers should work with the relevant authorities to establish a compliant database. Lastly, if the software uses Cloud storage, the Cloud service provider must be Chinese company.

Labeling Requirements for Non-Physical SaMD

Labeling requirements are the same as other medical devices. The special requirements for stand-alone medical software is that the label should clarify the technical characteristics and usage restrictions of key software interfaces. The label can be an electronic label available online.

On August 5, 2015, the NMPA (known as CFDA at that time) issued the Medical Software NMPA Registration Guidance (No.50, 2015). Stand-alone medical software and component medical software is collectively called medical software, so this guidance is applicable for stand-alone medical software.

On June 5, 2020, NMPA published the second draft for revision of Medical Software NMPA Registration Guidance. The final revision is not published yet and currently, we still refer to Medical Software NMPA Registration Guidance (No.50, 2015).

Please contact Asia Actual for insight on any special regulatory requirements. 

Special Licenses for Invoicing

To invoice hospitals, the distributor must have Medical Device Distribution Business License ( 医疗器械经营许可证).

Artificial Intelligence (AI) Medical Devices

Al software has special requirements, which are stated in “Technical Guideline on AI-Aided Software”, issued on June 28, 2019.

Patient Data Protections

Currently, there are no related regulations in China.

Cybersecurity

Medical Device Cybersecurity Guidance applies to SaMD, which was issued by NMPA on January 20, 2017.