The China Food and Drug Administration (CFDA, chin.: 国家食品药品监督管理总局) has announced numerous new standards for CFDA certification of medical devices. According to the official announcement number 36 from October 21, 2013 (Chinese version), respectively November 26, 2013 (English version), 104 new standards were published. All of them will become effective October 1, 2014.
Industry standards (norms) are abbreviated with “YY” and define the scope, parameters and prescriptive limits for product testing required for registration of medical products and devices by the CFDA. YY Standards apply when there is no Chinese GB Standard (GB stands for Guobiao, Chinese for “National Standard”) for the product. Therefore, GB Standards supersede YY Standards. Medical devices and products may also require other certifications, e.g.
CCC (China Compulsory Certification) and CEL (China Energy Label).
Of the 104 new standards 31 are mandatory. Some of the mandatory Standards refer to ECG diagnostics systems and others to devices that are used in maternity rooms. If there is a mandatory YY standard, the product must fully comply with the standard to be approved by the CFDA for the Chinese market.
There have also been 73 recommended standards that have been released, including medical devices used in the area of anesthetics und ophthalmology. These are not mandatory at this moment, but typically will be mandatory in the future, sometimes with very short notice.
There is also mention that there are changes to two existing YY Standards, however the YY Standards and the changes have not been specified as of yet.
As soon as the CFDA publishes official announcements and more information regarding these changes, we will inform you in our “News” section on our website. Please check our website regularly for up to the date and breaking announcements and planned announcements.
Regulations and Standards that are needed for approval and registration of medical products at the CFDA are similar to the International EC (European Commission) Standards. An example would be GB 9706.1:2007 (Medical Electrical Equipment) which directly corresponds with EC 60601-1:1995. Requirements and demands of CFDA may differ from those that European or U.S. authorities would require. The decision on whether product testing can be performed in test laboratories in the manufacturing country or need to be done at an accredited test lab in China is at the discretion of the CFDA. Close, careful communications are extremely important at all phases of the certification, but most crucial during the testing phase, when communications between the applicant and the testing laboratory is time sensitive.
If you want to learn more about CFDA certification of medical devices and products, please visit the CFDA section on our website. We also provide more detailed knowledge regarding CFDA in our free brochure “CFDA China – The Booklet” that can be downloaded here.
Please do not hesitate to call or email with any questions you may have.