China market access -- SFDA application services
The State Food and Drug Association (SFDA) is China's national regulatory body responsible for medical device regulation. With over 1.4 billion residents and an emerging health care system, China is ripe for the technologies of modern medical devices that the EU, Japan and the US have been valuing for decades. With UL SFDA application services, medical device companies can provide their technical file submissions in English first to make sure it meets the Chinese regulatory requirements prior to translation into Chinese. Helping our customers get their devices into emerging markets is just another way UL sets the standard for global regulatory certification services
Like many other international markets, China has a medical device classification system which is based on risk of the device. All devices must complete the registration process. However, in general, Class I devices do not need to have sample testing.
What is the process?
- Prepare the device design dossier in Chinese. The customer or application company can complete this.
- If Class II or III, it must be submitted for in-country testing by a SFDA-approved laboratory. Testing outside of China is not allowed at this time.
- If clinical trials are needed, then it must undergo in-country clinical trials.
- When all necessary testing is complete, submit to the SFDA. The SFDA evaluation center will review within 90 working days. If the device is approved, the SFDA final approval will be complete within an additional 35 days.
What documents do I need to prepare to apply?
- Legal registration requirements
- Certificate of quality management system (your UL ISO 13485 certificate is acceptable)
- Marketing approval certificate
- Authorization letters to registration agent in China
- Quality guarantee letter
- Truthful and accuracy self-guarantee letter
- Other documents as requested
Note: Some of these documents must be notarized copies.
Advantages to UL's SFDA application services
- Time savings -- Up to 33% quicker than other application service providers, so your product can get to market quicker and you can start selling your device in China sooner.
- Experience -- Over 200 completed SFDA applications so we can guide you through the process and anticipate revisions prior to waiting in the SFDA line.
- Global accreditation services -- UL is a leader at getting our customers access to existing and emerging markets so you only need to work with one regulatory and certification provider to meet your global sales and distribution needs.
- English review -- UL experts will review your technical files in English first before translation, to determine that requirements are met.
