The new article describes in detail the way a risk-based approach should be applied with respect to clinical trials involving human subjects, paying special attention to the initial risk assessment to be carried out by the party responsible for a clinical investigation before it will be commenced.
SFDA Guidance on Clinical Trials: Overview
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the application of a risk-based approach to monitoring clinical investigations. The guidance structured as a questions-and-answers document is intended to provide medical device manufacturers and study sponsors with additional clarifications regarding the regulatory requirements set forth under the existing framework, as well as recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.

Final Provisions

The final part of the guidance provides a summary based on the most important aspects to be taken into consideration by the entities conducting operations with medical devices. According to the document, these points could be described as follows: 

  1. All parties conducting operations with medical devices are obliged to ensure strict compliance with any and all applicable laws and regulations including, inter alia, the Medical Devices Law and Executive Regulations associated thereto. Furthermore, the authority reserves the right to take additional actions against entities operating in the sphere of medical devices in case of non-compliances occurred. For instance, the authority may impose fines and penalties. 
  2. The entities involved in operations with medical devices are entitled to object to the decisions taken by the authority, provided such objections are duly justified. Specific procedures to be followed in such cases are prescribed in the applicable legislation. 
  3. Should an establishment decide to cancel the license it currently holds, the appropriate notice should be provided to the authority. Such a request will be processed provided there are no pending obligations to be completed by the license holder. 
  4. In no event, the entities involved in operations with medical devices could use the name or logo of the authority in the course of advertising activities conducted. Nor such elements could be placed on the products marketed in the country or abroad, as this could potentially mislead customers. 
  5. When undertaking their activities, the entities involved in operations with medical devices should follow the principle of independence, impartiality, and integrity, ensure that there is no conflict of interest in the services provided in the case there is more than one activity at the establishment, and guarantee independence.

Terms and Definitions

The guidance also contains annexes providing additional information that could be useful for interested parties in the context of medical device establishment licensing. For instance, in one of the annexes, the authority provides definitions of the most important terms and concepts used, including, inter alia, the following ones:

  • Medical Supply – a medical material or product used in diagnosis, treatment, replacement, or correction/straightening; or in disability cases or other medical uses for humans, including medical gases. 
  • Establishment – a legal entity engaged in an activity related to medical devices and supplies. 
  • Consultation Services Establishments are defined as the ones that provide technical consulting services related to regulatory affairs to the establishments engaged in the field of medical devices in the Kingdom market. 
  • Clinical Trials Verification Establishments – the ones that take charge of follow-up clinical trials and conduct activities related to clinical trial verification. 
  • Quality Management System stands for a system approved by the FDA to verify the quality, effectiveness, and safety of a medical device or supply in accordance with the latest edition of the Technical Standard (ISO 13485) or its equivalent, as provided in the Regulations. 
  • Quality Assurance is a set of technical tests, measurements, and calibrations approved by the SFDA to verify the safety, accuracy, and quality of medical radiological devices in order to ensure the efficacy of diagnosis and treatment. 


License Details

Apart from the aspects described hereabove, the document also provides additional details regarding the existing types of licenses and outlines the key points associated thereto, including the license period and fees. In particular, the existing regulatory framework provides the following license periods:

  • For medical device manufacturers – 5 years;
  • For authorized representatives – from 1 to 10 years;
  • Distributors and importers of medical devices, as well as optics establishments – annual renewal;
  • Medical device warehouses, clinical trials verification establishments, service providers of technical advisory services for medical devices – 5 years;
  • Conformity assessment establishments and quality management system, medical device testing providers – 3 years. 

In summary, the present SFDA guidance describes in detail the requirements the entities involved in operations with medical devices should comply with in order to be allowed to undertake their activities. In accordance with the existing legal framework, the level of regulatory scrutiny depends on the risks associated with the particular activity conducted and the medical devices in question.

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