The cost and time required to apply for B-class medical device registration with the Saudi Food and Drug Authority (SFDA) can vary depending on several factors such as the complexity of the device, whether the manufacturer is local or foreign, and the documentation required. Below are the general details regarding the cost and timeline for the registration process:

1. Registration Costs

The costs associated with the registration of a B-class medical device with the SFDA generally consist of several fees. These include the application fee, possible inspection fees, and any other administrative costs. However, specific cost details may not always be publicly available, as the SFDA fees can change over time and vary by device type. That said, here’s a general breakdown of potential costs:

a. Registration Fees

• Application Fees: SFDA charges a fee for submitting the registration application. The fee is typically based on the classification of the device, and B-class devices usually fall into the mid-range category of fees.
  • The fees are generally in the range of SAR 5,000 to SAR 15,000 (approx. USD 1,300 to USD 4,000).
  • The exact amount depends on factors such as whether you are registering multiple devices or submitting for more complex review.

b. Inspection or Audit Fees (if applicable)

• If your device or manufacturing facility requires an on-site inspection or audit, there may be additional charges. These fees depend on the nature of the device and whether an inspection is mandated by SFDA.
  • The inspection fees are typically around SAR 2,000 to SAR 5,000 (approx. USD 530 to USD 1,300).
  • However, not all B-class devices will require an inspection, and SFDA will decide based on the complexity of the device and its manufacturing process.

c. Authorized Representative Fees

• If you need to appoint a local authorized representative in Saudi Arabia, there will be associated fees for their services. These fees vary based on the representative's expertise and services but typically range from SAR 5,000 to SAR 20,000 annually (approx. USD 1,300 to USD 5,300).

d. Additional Fees

• Translation Fees: If your documents need to be translated into Arabic (such as labeling, IFUs, etc.), there could be additional costs for translation services.
• Quality Management System (QMS) Certification Fees: If you don’t already have ISO 13485 certification or similar, you may need to pay for a third-party certification audit, which could cost anywhere from USD 5,000 to USD 10,000 depending on the certifying body and the complexity of your manufacturing processes.

2. Timeframe for Registration

The timeframe to complete the registration process for a B-class medical device can vary depending on several factors, including the completeness of the application, the complexity of the device, and whether any additional information or clarifications are needed by the SFDA. On average, the process involves the following timelines:

a. Initial Submission

• After submitting your application and required documentation through the SFDA MDES portal, the initial review can take between 1 to 3 months. This time allows SFDA to evaluate your device's safety, performance, and compliance with regulatory standards.
  • If your submission is complete and well-organized, the review can be faster. However, if there are missing or unclear documents, SFDA may request additional information, which can delay the process.

b. Inspection (if required)

• If your device requires an inspection of the manufacturing facility or an audit of the QMS, this could add 1 to 2 months to the timeline.
  • Not all B-class devices require such an inspection, and SFDA will determine this based on the risk associated with the device and the manufacturing process.

c. Final Review and Registration

• After the initial evaluation, including any inspections or clarifications, SFDA will issue a registration certificate for approved devices. The final registration process may take an additional 2 to 4 weeks.
  • If your device is approved without needing additional inspections or major clarifications, the entire process can take about 2 to 4 months from the initial submission to receiving the registration certificate.

d. Total Estimated Timeframe

• On average, the total time for registering a B-class medical device with SFDA typically ranges from 3 to 6 months. This includes time for document review, possible inspections, and any necessary follow-up actions.