Chinese Medical Device Registration Update

– SFDA introduces 96 new Industrial Standards

In December 2010, China SFDA introduced has introduced 96 new Industrial Standards which will become part of medical device requirements from June 2012. 

All devices supplied in China must comply with product standards equal or more stringent than the respective Chinese National or Industrial Standard.  Manufacturers must compile a Product Standard Dossier  (产品标准)  which is broadly equivalent to a Summary Technical File.  The Dossier must include detailed evidence of standards compliance.  Certification to International standards such as ISO and IEC are not automatically recognised by SFDA.  

Ideally products should meet Chinese National Standards (国家标准), or Industrial Standards (工业标准) although a  manufacturer’s own Enterprise Standard (企业标准) may be used in the absence of an applicable National/Industrial standard.

The 96 standards introduced incorporate 34 Mandatory Standards and 62 “recommended standards”, covering a wide range of products including

• Bioabsorbable sutures ,
• Blood pressure monitoring and electrocardiographs
• Single use injection devices,
• Steam sterilizers
• Chemiluminescence analysis for tumor marker, cancer antigen and carbohydrate antigen
• IVDs and Lab equipment
• Dental equipment
• Biomaterials

Overseas manufacturers need to exercise great care when using existing ISO/IEC certification to support Chinese registrations. Any existing ISO or IEC certification needs to correspond to an identical Chinese National/Industrial Standards to be recognised by SFDA. 

Choosing The Right Standard For Type Testing

The Product Standard Dossier is the foundation for mandatory Type Testing (注册检测).  Inclusion of incorrect standards will not be detedcted until SFDA review – which comes AFTER the type testing has been completed.  Getting this wrong can result in lengthy registration delays and expensive test reruns.

Need help with navigating SFDA registration and understanding the Technical Requirements for SFDA review?

The chief of Brandwood Biomedical Beijing office, Dr. Davey Han, has extensive experience working with SFDA.    Dr Han’s close working relationships at a senior level with the SFDA and deep knowledge of requirements facilitates active dialogue with the agency and a smooth regulatory review.

For specialist professional advice on SFDA registration and service tailored to your specific needs click here to contact us.

Han (Davey) De Hui and Xiao (Lucy) Yan Zhu

Click here to download a more detailed review of the new standards and the implications for your China Registration

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Fresh approach for ISO 14155 – International standard for the Clinical Investigation of Medical Devices

A revised version of  the clinical evaluation standard ISO 14155, the international standard for the clinical investigation of medical devices was released earlier this year, and sees a number of updates and changes to the standard. The new standard combines the previous two standards of ISO14155 (Part 1 and 2) into one and has been reformed to level the playing field for clinical investigations conducted around the world – both economically and ethically.

ISO 14155 is not as well recognised as other ISO standards, with Japan and the U.S FDA failing to accept the old standard.  It has been argued that the standard lacks essential details and content, which are challenging to include in a document that needs to be flexible enough to pertain to clinical evaluations conducted all over the world under different conditions. However, the rewrite has been harmonised with ICH GCPs where possible while still remaining device-specific. The new approach deals with clinical research from a project management perspective, with the inclusion of sufficient narrative to teach a sponsor how to conduct a clinical investigation.