PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Monday, 03 August 2020

MCAZ, Medical devices laboratory does regulation and quality conformity assessment of male condoms and medical gloves. Medical gloves and male condoms are regulated prior to distribution as per SI 1 of 2006 and SI 183 of 2005 respectively. The laboratory is ISO 17025 accredited by SADCAS in condom testing methods. Quality conformity assessment tests of male condoms and medical gloves are performed in accordance with international standards and WHO guidelines and specifications.

Male condoms and medical gloves types and brands are initially registered and granted market authorisation prior distribution. Routine compliance checks of subsequent shipments is also done for all the condom and glove batches imported into the country.

 

Quality conformity assessment of male condoms

The Medical Devices Laboratory is equipped with specialized equipment quality conformity assessment of condoms. Condoms are tested for compliance to standards set by the International Standards Organization (ISO) and the World Health Organization (WHO), and the following tests are done;

1. Determination of bursting volume and pressure

2. Freedom from holes and visible defects

3. Package seal integrity test

4. Dimensional testing (Length, Width and Thickness)

5. Determination of total lubricant for condoms in individual containers

 

Quality conformity assessment of medical gloves

The Laboratory is also equipped with specialized equipment for quality conformity assessment of medical gloves. Medical gloves are tested for compliance to standards set by the International Standards Organization (ISO), and the following tests are done;

1. Water tightness test

2. Dimensional testing (Length, Width and Thickness)

 

Download the MCAZ guidelines and regulations for latest gloves.

 

Click Here to view Process flow

 

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