Medical Device Recalls in China – are you prepared?

Perhaps you are still eyeing the $8 billion medical device market in China or maybe you have already set up your shop there. Either case, you should make sure you are aware of this newly published guideline on medical device recalls, the Provision on Medical Devices Recalls (interim) 医疗器械召回管理办法（试行）

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Proposed Chinese Clinical Trial Exemption for some Class II Medical Devices

Some class II device manufacturers may soon be exempt from providing Chinese clinical trial data for regulatory approval in China - meaning a substantial reduction in regulatory burden for many Class II devices manufacturers.

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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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China and You

The seminar and networking party for our 10th anniversary was a huge success - with a full house in both the Sydney and Melbourne venues.  Thanks to all of our friends and partners who honoured us with their presence.  We were delighted to see you there and even more delighted at the energetic discussions and debates that took place in the seminars.

For those that missed the seminar, the slide set for Davey Han's very thought provoking presentation on the challenges and opportunities in the emerging Chinese market are available for download here.

Some key messages from Davey's presentation:

 

The China Medtech market growth is accelerating



There's an ambitious National Health Care Reform Plan which will see an additional $US 123 Billion of infrastructure and other funding over 3 years, delivering  22 thousand new local hospitals and clinics and about 1600 larger hospitals and that will see 90% of the population have some level of health care insurance by the end of this year...

The procurement program to supply the expanded hospital services is huge

China as a low price country is a myth...  There is a premium on advanced technologies which means that high tech devices particularly attract higher prices in China than in the USA.  Higher volume commodity products tend to be lower price - but of course the sales volumes are very large.

China Regulatory affairs is different for sure - but entirely manageable with the right knowledge and approaches and approval timelines are increasingly in line with major western agencies.  

Good regulatory knowledge is important - strategy is essential and there are ways of doing business that can accelerate your penetration of the China market.  For example did you know it's possible for some devices to deal with a provincial SFDA, and to obtain support from the provincial government for setting up your operations in China? Interested to learn more - contact us for a no obligation discussion about China and You.