16 Sep Key Steps for Ensuring SFDA Compliance for Medical Device Registration

Manufacturers must comply with the requirements set by Saudi Food and Drug Authority (SFDA) regulations to export into the Saudi market. The SFDA process of registering medical devices is necessary to ensure that the medical devices exported to Saudi Arabia are expected to meet safety and quality standards.

This blog explains how manufacturers can create a step-by-step navigation of the SFDA medical device registration process to ensure compliance and preparation for the market.

Understanding SFDA Compliance for Medical Device Manufacturers

Classify the Medical Device

The first step in SFDA compliance is classifying the medical device according to its risk level. Similar to the other regulatory agencies involved in medical devices worldwide, the SFDA classifies medical devices into four classes: Class I, which categorizes the lowest risk; Class II, which represents the majority of low- to moderate-risk devices; Class III, which represents a high to critical risk; and Class IV, with extremely high risk. Importantly, classification determines the degree of complexity in its regulatory requirements.

For instance, a simple device like a thermometer would fall under Class I; however, the pacemaker would fall under Class III due to the dangers exposed to patients. The manufacturer has to know well the use and risks associated with their device, which enables him or her to come up with its classification. This requires accuracy since misclassification may cause ample delay or even denial of application for registration.

Appoint a Local Authorized Representative

Manufacturers outside Saudi Arabia should appoint an SFDA authorized representative. This authorized representative serves as the contact point for the manufacturer and the SFDA. This allows for safeguarding the manufacturer’s interests when implementing these operations in accordance with the regulatory requirements of the locality. In this regard, the authorized representative must be found in Saudi Arabia and aware of the local laws so that all requirements from the SFDA can be responded to in due time.

In practice, this role will involve more than the facilitation of communication, as it will include post-market surveillance, collaboration with compliance audits, and ensuring that there is a renewal of registration of devices at appropriate times. The authorized representative thus would be the single most critical player ensuring continued compliance for the manufacturer’s products beyond the initial period of registration.

Prepare and Submit Technical Documentation

This is perhaps one of the most important registration requirements to the process at the SFDA, involving preparing and submitting all technical required documentation. This includes:

Product Specifications: All specifications in relation to the design, contents, and functionality.

Risk Management File: Evidence of identification, evaluation, and control of the risks associated with the medical device; this conformity shall be obtained in conformity to international standards like ISO 14971.

Clinical Evaluation Report: Clinical evidence that the device is safe and performs as intended based on clinical data. High-risk devices may have to add clinical studies.

Instructions for Use (IFU): Simple and easy-to-understand instructions on proper usage of the device safely and efficaciously.

These documents are not only required for registration, but they also come under the scanner for the lifetime of that product. Hence, manufacturers have to be precise and be in accordance with SFDA rules all the time.

Ensure Compliance with Saudi Labeling Regulation

Medical device labeling is, in itself, a component of SFDA. A manufacturer should ensure that its devices are supplied with Arabic and English labeling and that the labels contain:

• Name and intended use of the device
• Manufacturer’s name and address
• Batch or serial number for traceability purposes
• Any warning or precaution
• Instructions on how to use the device

For high-grade devices, there may be additional labeling conditions, particularly those related to sterility or the presence of harmful substances. Failure to meet some of these labeling conditions may bar the device from entry into the Saudi market even with a favorable safety and performance profile.

Periodic Renewal of Registration

Registration of medical devices with SFDA is not a one-off activity. It must renew the registration every five years. Renewal involves resubmission of updated technical documentation, demonstrating continued conformity to SFDA standards, and demonstrating that the device is still safe and efficient for use in the market.

The renewal process is time-consuming, especially for manufacturers who have so many product lines, but it is an essential procedure for keeping devices legal in Saudi Arabia. Late renewal of registration may lead to a product recall and suspension from the market.

Final Words

The SFDA medical device registration process is multi-phased requiring extreme care in details needed during classification, documentation, and continuous compliance efforts. For manufacturers, preparation will be the way to success, as well as the proper appointment of a reliable SFDA-authorized representative, ensuring ongoing post-market surveillance, as well as quality management.

If this process is followed, the manufacturers will have confidence in offering SFDA-compliant products while having that compliance as a kind of enabler to access the massive Saudi Arabian market and potentially be on a par basis in competing for dominance there.

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Last Updated on September 16, 2024 by Marie Benz MD FAAD