Yes, there are specific labeling and packaging requirements for medical devices in Kenya as per KeMDA regulations. Some of the key requirements include:
1. Labeling Requirements:
- The label should be in English and prominently display the name of the device, its intended purpose, and the manufacturer's details.
- The label should include information on how to use the device safely and effectively, including any warnings, precautions, or contraindications.
- The label should indicate the batch number, expiry date, and storage conditions of the device.
- The label should comply with any specific labeling requirements for the particular type of medical device.
2. Packaging Requirements:
- The packaging should be designed to protect the device during storage, transportation, and use.
- The packaging should include a package insert or instructions for use that provide information on how to use the device safely and effectively.
- The packaging should comply with any specific packaging requirements for the particular type of medical device.
3. Unique Device Identification (UDI):
- Medical devices should have a Unique Device Identification (UDI) marking on the label or packaging, as per international standards.
4. Language Requirement:
- The labeling and packaging should be in English, although additional languages may be included if necessary.
5. Regulatory Markings:
- The packaging should include the KeMDA registration number or other regulatory markings as required by KeMDA.
These requirements help ensure that medical devices are properly labeled and packaged to protect the health and safety of patients and users. It's important for manufacturers and importers to familiarize themselves with these requirements to ensure compliance when registering and marketing medical devices in Kenya.
