Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose. Therefore, medical device manufacturers must gain a clear understanding and comply with the updated Health Authorities labeling regulations.
Recently, the Saudi Food and Drug Authority (SFDA) has released a guidance specifying the labeling requirements for medical devices. The guidance aims at providing additional recommendations and clarifications regarding the Regulatory requirements for medical devices labeling. Let us unveil what they are?
Firstly, the guidance defines the most important terms as mentioned below.
1. MDMA – Medical Devices Marketing Authorization, permission necessary to place a medical device on the market.
2. Labeling – A written, printed, or graphic matter (a) affixed to a medical device or any of its containers or wrappers, (b) information accompanying a medical device, related to identification, technical description, (c) information accompanying a medical device, related to its use, but excluding shipping documents.
3. Advertising of Medical Devices – Any form of information, canvassing activity, or inducement intended to promote the supply or use of medical devices.
4. Instructions for Use (IFU) – The information provided by the manufacturer to inform the device user of the medical device`s intended purpose and proper use and any precautions to be taken.
- To obtain MDMA, a medical device shall comply with the applicable Regulatory requirements outlined in Australia, Canada, Japan, the USA and the EU/EFTA, and the applicable requirements in Saudi Arabia.
- Manufacturers must submit the labeling copies which the foreign Regulatory Authority already approved in the format used in Saudi Arabia. The regulating authority will assess the applicable Regulatory requirements for the language used, completeness of the information provided and the suitability for medical device identification and tracking purposes.
- The information provided on the label should be understandable for the intended end-users based on their knowledge and qualifications. To place an intended medical device in the domestic market the labels must be provided in Arabic and/or English. In the case of medical devices intended to be used by only healthcare professionals, labeling in English is sufficient. If the provided space on a medical device that is intended to be used by laypersons is insufficient to accommodate information in both Arabic and English, then the information should be provided in Arabic.
- The information and instructions for handling, storage, transportation, installation, maintenance and disposal of medical devices must be in English and in Arabic where necessary; in the case where medical devices are intended to be used by the health professionals. The wordings should be in a readable and understandable format for the potential users of a medical device.
- If the device is intended to be used by healthcare professionals, all the marketing and advertising information could be provided in English, in other cases Arabic is required.
Additional Labeling Requirements
- The information about the nominal frequency and the voltage is required for a medical device requiring an a/c power supply. Further, information on operating temperature, humidity and the potential impact of electromagnetic disturbances and the ability of a medical device to withstand them should be included.
- The label information should be provided in a human-readable format according to the requirements for language as described above, and it could be accompanied by RFID or bar codes.
- Electronic Instructions for Use (eIFU) are allowed, and they should be accessible for potential users of a medical device. There should be an option to obtain the IFU in paper format and it should be clear for a potential user how the correct version could be found. Further, it is important to mention that eIFU is allowed only for medical devices intended to be used by healthcare professionals and the paper format is mandatory in the case of medical devices intended to be used by laypersons.
- The logo of the regulating authority or the registration number of the manufacturer will not be included in the labeling (the Establishment National Registry Number). It could include the number assigned to the medical device itself – the Medical Device National Listing Number, which is connected to the Medical Device Marketing Authorization granted by the Authority.
In addition, the SFDA guidance on labeling requirements also provides information about the associated risks with the medical devices and contains details about the warnings, limitations, and contradictions. Device manufacturers aiming for Saudi Arabia’s market entry must abide by the SFDA requirements for a compliant market entry. Consult a proven regional Regulatory expert for further assistance. Stay informed. Stay compliant.