Potentially Broader Applications

Although this regulation was drafted by the MII and initially focused on electronic and information products, its impact surely will reach beyond this industry as the regulation gains its popularity and exposure in the open market.  

Medical devices companies, especially those whose products have 60% or more electronic contents in a product, should consider complying with this regulation immediately. To help companies assess their potential compliance needs, the MII issued a reference product list, which includes the following medical device categories:

•    Medical electronic instruments and equipment (monitors and recording devices used for heart,              brain, muscle movement, eye and other vital sign monitors)
•    Medical ultrasound systems
•    Medical laser instruments (diagnostic, measurement and treatment instruments)
•    In-vitro diagnostic instruments and centrifuges
•    High-frequency and ultra-frequency diagnostic and treatment equipment (including X-ray,                         nuclear treatment systems)
•    Chinese medicine instruments (including electromagnetic treatment, light therapy and acupuncture       instruments)
•    Other medical electronic instruments (including medical lighting instruments, dialysis and                       circulation/purification equipment)

Please note that this list is not the mandatory control list but, instead, a guidance document. It is likely that some products on this list would be selected to be on the mandatory list in the future. But by March no medical products are subject to mandatory testing.

Just as with other new regulations, this Chinese RoHS law is not complete (or necessarily thorough) at present. Gray areas and ambiguities surely will be identified and need to be addressed in future regulations. Stay tuned for more developments.