Operon Strategist

Office 14, 4th Floor, MSR Capital, Morwardi Road, Pimpri Colony, Pimpri, Pune 411018, Sydney, NSW

The Kingdom of Saudi Arabia( KSA) officially introduced a new regulation governing medical devices, which is slated to take effect latterly this year. In affiliated news, the Saudi Food and Drug Authority( SFDA) extended the use of the GHTF expedited market access route and published a guidance document on artificial intelligence in medical software and an updated classification guidance.

The first step in preparing a Riyadh, Saudi Arabia device for marketing in the United States is to determine how the FDA has classified your device. A medical device is defined by law in section 201( h) of the Federal Food, Drug and Cosmetic( FD&C) Act.

Medical devices in the United States are distributed into one of three classes( I, II, or III), based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control, and class III devices subject to the most stringent regulatory control.

Based on the classification and the regulatory strategy, you must determine if a clinical trial is necessary. Clinical development, clinical trial design, protocol development, and choosing the right CRO Services are very important first way for a successful clinicaltrial.However, the data operation won't show you what you need, If the clinical coordinator and site management aren't endured.

Once your device has been classified, as your Riyadh, Saudi Arabia medical device consulting partner, we can act as your US agent and help with your regulatory strategy and prepare the applicable premarket submission, if one is needed for your specific device. For most medical devices, the appropriate submission type is identified within the product classification, which may be attained from the Product Classification database.

Operon Strategist is a Medical device consulting company for Saudi Arabia which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide the clients customized solutions to manufacturers looking to set up a world-class manufacturing unit.

Medical device Registration in Saudi Arabia requires previous approval in one of the following reference markets Australia, Canada, Europe, Japan, or the USA. Generally, your medical device or IVD classification in the reference market will determine how the SFDA classifies your device. Authorized person should be appointed in Saudi Arabia, as he must have authorized representative and must gain representative license, and renew it on annual basis, Submitting all document and application to the needed authority and represent you in Kingdom of Saudi Arabia.

Recently published guidance details evaluation of medical software using artificial intelligence( AI) and big data

The SFDA has published MDS- G53, Guidance on Review and Approval of Artificial Intelligence( AI) and Big Data Based Medical Devices, which outlines the MDMA conditions relevant to AI- based medical devices. Among the requirements listed is to demonstrate the accuracy of AI technology to diagnose or prognosticate conditions or give customized treatment to cases by parsing medical big data and recognizing certain patterns based on machine learning.

The first half of the guide focuses on criteria for determining whether a software product is a medical device along with its potential risk classification, not offering any specific rules for software utilizing AI. The alternate half establishes considerations for review and approval of software applications, with an overview of expectations for AI- based software. Important factors contain the verification of compliance with the Essential conditions, management of changes through version control, and the regulation of cloud computing technology.

This is just a brief overview of how to prepare a Riyadh, Saudi Arabia medical device for marketing in the United States. To learn more about how Operon Strategist can give the necessary medical device consulting to help insure your successful entry into the US market, contact us today.