New Zealand Legislation: Regulations

11 Medical device risk classifications in general

• (1) Medical devices have the following risk classifications:

  • (a) Class I:

  • (b) Class IIa:

  • (c) Class IIb:

  • (d) Class III:

  • (e) Class AIMD (Active Implantable Medical Device).

  (2) Class I is the lowest level of risk classification; Class IIa and Class IIb are successively higher levels of risk classification; and Class III and Class AIMD (Active Implantable Medical Device) are the highest levels of risk classification.