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Medical Device Certification in Other Countries

Product Groups for in vitro diagnostic medical devices

   Source��   outao

List A
List A of Annex II contains the products with the highest potential risk. These include reagents, calibrators and controls for the determination of
blood groups (ABO system, rhesus, and anti-Kell)
HIV-1/-2 infections, HTLV-I/-II infections, and hepatitis B, C, and D.

List B
List B of Annex II contains high risk products (reagents, calibrators and controls unless otherwise stated):
for the determination of blood groups(anti-Duffy and anti-Kidd)
for determination of irregular anti-erythrocyte antibodies
for the detection of rubella and toxoplasmosis
for the diagnosis of phenylketonuria
for the detection of infections withcytomegalo virus or Chlamydia
for the determination of the tumour marker PSA
for the determination of HLA tissue types DR, A, B
for the evaluation of the risk of trisomy21, including softwareproducts
for self-testing of blood sugar levels Including instruments

Devices for Self-Testing:
These are subject to special requirements, which are described in Annex I, Section 7 of the Directive.

The product must be easy to use for laypersons, and the enclosed instructions must be easy to understand.
The risk of errors in use or in the interpretation of results must be kept as low as possible.
Where possible, such devices must include a user control which allows verifcation of correct performance at the time of use.

Other IVD Medical Devices:
Products that are neither listed in Annex II nor intended for self-testing.