Medical equipment regulations vary significantly from country to country, going from in-depth to completely non-existent. Over time, this disparity prompted a growth in the number of laws governing medical technology.
In 1992, the Global Harmonisation Task Force (GHTF) was founded to push for the standardisation of medical device laws around the world. It was an informal coalition whose original members were the US, the European Union, Japan, Australia and Canada. The Kingdom of Saudi Arabia also joined the GHTF.
Then in 2001, a model regulation was published by the World Health Organisation (WHO) with the goal of avoiding further inconsistencies amongst laws applicable to medical devices. It served as a template for lawmakers to follow when the time came for them to develop their own medical device regulations.
This model drove home the point that the medical device sector is intricate and nuanced, and pointed to problems with the rules and regulations that govern the industry.
The GHTF was then succeeded in 2011 by the International Medical Devices Regulation Forum (IMDRF), formed voluntarily by medical device regulators from around the world. The objective of the IMDRF was to accelerate the regulatory convergence and harmonisation process for medical devices. Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea, the UK and the US are all current members of IMDRF.
Saudi Arabia has since adopted regulations governing medical devices that are grounded in the standards set by the IMDRF and the GHTF.
Manufacturing, importation, marketing, and distribution of medical devices in Saudi Arabia are all regulated by the Saudi Food & Drug Authority (SFDA). SFDA has published several regulations and guidance notes providing clarity on the laws applicable to the medical device industry.
Medical Device Marketing Authorisation in Saudi Arabia
SFDA issued a guideline note on Medical Device Marketing Authorisation. This was in accordance with the Medical Device Law, issued by Royal Decree No. (M-54). The purpose of the guidance note is to provide clarity on the steps involved in procuring Medical Device Marketing Authorisation (MDMA) for the commercial distribution or use of medical devices.
For launching a medical device in the Saudi Arabian market, the guidance note is applicable to both domestic and foreign medical device manufacturers and their authorised representatives.
Definition of a medical device
Based on the definition provided by IMDRF, a medical device is defined as any; machine, instrument, application device, transplant device, laboratory reagents, laboratory calibration materials, software or operating materials for medical devices, or any similar or related device manufactured alone or with other devices.
To be defined as a medical device, the above should serve at least one of the following purposes:
- Diagnose, prevent, control, control, treat, relieve, relieve or compensate for injuries
- Examination, replacement, modification, anatomical support or support influencing the functions of the body’s organs
- Support or enable life to continue
- Regulate or assist pregnancy
- Sterilise medical devices and supplies
- Give information for medical or diagnostic purposes derived from laboratory tests of samples from the human body
Regulatory requirements
Authorisation regarding marketing a medical device in Saudi Arabia can be obtained from SFDA. Upon receipt of such marketing authorisation, the medical device can be marketed, distributed and used.
The applicant is responsible for ensuring that they observe all laws, rules and guidelines relevant to their application. The essential principles for safety and performance must be met, and the medical device must be eligible under the conditions indicated.
— Jean Abboud is the Head of Corporate, KSA at BSA Ahmad Bin Hezeem & Associates LLP.
