The new article provides additional details regarding the regulatory requirements to be applied concerning labeling for certain types of medical devices, including the in vitro diagnostic (IVD) and sterile products, as well as active and implantable medical devices.
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The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the labeling requirements for medical devices. The document describes in detail the regulatory requirements the labeling should meet and also provides recommendations to be followed by medical device manufacturers and other parties involved in placing medical devices on the Ethiopian market. However, the document is non-binding, and the authority reserves the right to make changes thereto, should it be reasonably necessary to reflect the respective amendments and modifications to the underlying legislation.
Additional Requirements: Key Points
According to the guidance, certain medical devices are subject to special labeling requirements. The additional information to be provided in the labeling could include, inter alia, the details regarding:
- Special storage and/or handling conditions the product is subject to (such details should be provided on the external packaging);
- The approach to be applied to ensure the device is properly installed, as well as regarding the maintenance the product should undergo;
- Additional procedures to be performed before using the device;
- The type of the device (e.g., single-use, reusable, or intended for research use only);
- Compatibility and connection with other medical devices and equipment intended to be used together or in the same user environment;
- Risks associated with the implantation of the device;
- Risks associated with the potential interference;
- Radiation emitted by the device (if applicable).
Apart from that, the authority mentions that in case the product is a refurbished medical device, this should be clearly stated in its labeling.
Labeling Requirements for IVD Devices
As described by the EFDA, in the case of in vitro diagnostic medical devices, the labeling should additionally contain the following information:
- The label should contain a clear initiation that the product is an IVD device;
- The instructions for use (IFU) should outline
- The intended purpose of the device, including the details related to the analyte, test type (qualitative or quantitative), the way the test impacts the processes, indications for use, specimens to be analyzed, intended users (e.g., healthcare professionals or patients themselves), type of assay, as well as the details rearing the instruments necessary;
- The main principle the test conducted by the virtue of the device is based on;
- Details regarding the specimen, including the way it should be collected and prepared;
- Information about reagents and the way they should be used;
- Methods for calculation and interpretation of the results the device provides;
- Details regarding substances that could potentially cause interference and impact the accuracy of test results;
- Analytical performance characteristics, such as sensitivity, specificity, accuracy (trueness and precision);
- Additional factors to be considered to ensure the accuracy of the results;
- Aspects related to the use of calibrators and control materials;
- General information about the design of a study and the device is intended to be used.
Sterile Medical Devices
The document also describes the requirements to be taken into consideration concerning medical devices that are intended to be supplied sterile. Apart from the general labeling requirements, the following ones should be applied:
- The labeling should contain a clear indication that the product is sterile. Moreover, it is important to provide instructions regarding the actions to be taken to ensure sterility in case the packaging is damaged, together with the methods of re-sterilization, if applicable.
- Should sterility be required only for one or several components of the device, such components should be indicated.
- If the device should be sterilized before use, it is necessary to describe at least one method to be used.
- If the product in question is a single-use medical device, it should be clearly stated that it cannot be disinfected and reused.
- If the packaging contains several devices, some of which are not sterile, it should be clearly described in the labeling to avoid creating an impression that all the products in the packaging are sterile.
- If necessary, the labeling should also contain instructions regarding the proper way to open the packaging to ensure the sterility of the device itself.
Requirements for Active Medical Devices
Special labeling requirements should be also considered concerning active medical devices. According to the guidance, additional information to be provided includes, inter alia, the following details:
- Electrical needs of the device (voltage);
- If the product requires connection to other devices to be used for its intended purpose, it is also necessary to describe the way the proper devices should be identified to ensure compatibility and safety.
- In the case of the radiation-emitting product, it is also necessary to provide the details regarding the radiation emitted including its nature, type, and intensity; and also the information regarding calibration and inspection of the product to be conducted by a qualified expert.
- If the product is a light-emitting device, the information should contain:
- For laser devices – the indications of the type, class, wavelength, and power output of the laser;
- For sunlamp devices and ultraviolet lamps the labeling should contain a warning “DANGER – Ultraviolet radiation, Avoid overexposure”.
Labeling Requirements for Implantable Medical Devices
Special requirements should be also applied in the case of implantable medical devices due to the specific nature of risks associated thereto. As described in the guidance, the labeling for such products should contain such details as:
- An indication of its biocompatibility with the human body;
- Duration of implantation;
- Any side effects or contraindications;
- Material property, the origin of the material;
- Method of implantation.
According to the guidance, if the product is a refurbished medical device, this should be indicated in its labeling, which should also contain the details regarding the entity responsible for refurbishing, the date when it was conducted, the validity date, and also the details regarding the changes in comparison to the initial medical device in terms of parameters and limitations.
The document also outlines specific exemptions related to the labeling requirements. The exemptions set forth under the applicable legislation are the following ones:
- A product in the laboratory research phase is not represented as a medical device that is prominently labeled: “For Research Use Only. Not for use in diagnostic procedures”; and
- A product that is being shipped or delivered for product testing before full commercial marketing that is prominently labeled: “For Investigational Use Only”.
In summary, the present EFDA guidance describes in detail the labeling requirements to be followed concerning the medical devices intended to be marketed and used in Ethiopia. The document pays special attention to the device-specific requirements to be considered in the case of different types of medical devices.
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