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Medical Devices-Asia and ROW Regulatory News-July 2023

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  1. The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and 
  2. There are no significant changes in the design and intended purpose; and
  3. The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.