Product Compliance and Regulatory Information Resources for Measurement, Control, and Laboratory Devices

Thursday, May 19, 2011

CCC Mark for Mixed Systems Using Products Not Subject to Compulsory Certification

One of the questions that always comes up, and is a frequent topic for discussion when dealing with CCC, is the topic of ITE peripherals as part of a larger "system". How does CCC apply to ITE peripherals imported as part of a non-CCC regulated device, such as a large medical laboratory device?

Well, the answer is - CCC is not applicable - to a degree. The importer will still need to apply for an exemption approval for the ITE devices when clearing the goods in customs. No (external to China) agency can provide exemption approval. This needs to be done by the importer when clearing customs.

This problem is exacerbated by the possible need to later send a replacement ITE device for the larger system. At that time, the device will likely not be allowed to enter since it has no CCC certification. Manufacturers and inporters have resorted to locally sourcing replacement ITE devices to circumvent this problem.

Bottom line, specifiy CCC compliance from your OEM ITE equipment provider. Yes, it may be more expensive, but it will certainly allow for a smoother process going into China.

For more on China the China CCC mark, see earlier post, Guidance on CCC Marking for China.

Thursday, May 12, 2011

UL | IEC UL 61010 International Activities Blog

UL has set up a blog to discuss and provide updates on the activities surrounding the upcomming 3rd edition of the 61010 standard. Follow this link and sign up:

UL IEC UL 61010 International Activities Blog