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Medical Devices

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Medical Devices

It means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article   intended by the manufacturer to be used, alone or in combination, for humans or animals.

It can be used for a combination of activities;

  1. Diagnosis, prevention, monitoring, treatment or alleviation of disease.
  2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
  3. Investigation, replacement, modification or support of the anatomy or of a    physiological process.
  4. Supporting or sustaining life
  5. Control of conception
  6. Disinfection of medical devices
  7. Providing information for medical or diagnostic purpose by means of in vitro  examination of specimens derived from the human body

Applicants are strongly encouraged to familiarize themselves with the criteria and requirements for review processes outlined in this guidance and the other relevant guidance documents before submitting their applications.

Clinical Evaluation of Medical Devices

Once the scope has been defined, there are three discrete stages in performing a clinical evaluation:

Identification

Identification of pertinent standards and clinical data

Appraisal

Appraisal of each individual data set, in terms of its relevance, applicability, quality and clinical significance.

Analysis

Analysis of the individual data sets, evaluation of the performance, safety, and presentational aspects of the medical device are reached.

Evaluation

At the end of the clinical evaluation a report is prepared and combined with the relevant clinical data to form the clinical evidence for the medical device.

Guidelines and Important Downloads

Guidelines and Important Downloads