We position our clients to make their business growth smooth and advancing their agenda, Business Growth, Security, High Quality Team, Performance With our consultants holding 10+ years of experience and extensive knowledge of KSA medical devices market and regulations, MUHM has designed its infrastructure which works best for our customers in the process of medical devices with the SFDA, covering medical devices of all classifications and various jurisdictions.
Muhm is a consultancy companies that provide Medical Device Distributors &
Manufacturers with the Regulatory support needed to ensure a high level of
accessibility in Kingdom of Saudi Arabia
Working closely with various Regulatory Authorities all over MENA region like:
Saudi Food and Drug Authority (SFDA),
Muhm is always pleased to be part of your success by assisting your business
process in a high-level of Commitment through guiding and advising manufacturers
on all the requirements pertaining to PRE and post-marketing requirements
regarding all issues concerning medical devices, in-vitro diagnostic devices,
contact lenses, laser surgical equipment and healthcare all over K.S.A.
Muhm is specialized in providing the compliance for ISO 13485 and engaged until
the successful of your certificate completion.
To ensure that an establishment is able to: Undertake all necessary customs procedures. Undertake all activities required to ensure appropriate management of the medical devices it import or distribute.
For the manufacturers located outside the Kingdom of Saudi Arabia (KSA) that wish to register their products with the Saudi Food and Drug Authority (SFDA), they must assign an AR ‘’Authorized Representative’’ to work on their behalf when dealing with SFDA for anything related to the medical devices, IVD products registration and post-marketing services, beside communication with SFDA for any questions or inquiries.
The Saudi Food and Drug Authority (SFDA) is an independent body corporate that directly reports to The President of Council of Ministers, and its main objectives are to ensure safety of food, drug for human and animal, medical devices, and the safety of biological and chemical substance as well as electronic devices that are related to human health. The main purpose of the SFDA establishment is to regulate, oversee, and monitor food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether the products are imported to the country or locally manufactured. The authority is responsible for monitoring.
Medical Device manufacturers who wish to place
their medical devices and IVD products in the Saudi market must first
get the Medical Device Marketing Authorization (MDMA) approval from the
Saudi Food & Drug Authority ‘’SFDA’’ through their Saudi ‘’Authorized
Representative’’ to be able to ship, sell or distribute those
products.
It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose for Manufacturers & Distributors
To ensure that an establishment is able to: Undertake all necessary customs procedures. Undertake all activities required to ensure appropriate management of the medical devices it import or distribute. .
For the manufacturers located outside the Kingdom of Saudi Arabia (KSA) that wish to register their products with the Saudi Food and Drug Authority (SFDA), they must assign an AR ‘’Authorized Representative’’ to work on their behalf when dealing with SFDA for anything related to the medical devices, IVD products registration and post-marketing services, beside communication with SFDA for any questions or inquiries.
The Saudi Food and Drug Authority (SFDA) is an independent body corporate that directly reports to The President of Council of Ministers, and its main objectives are to ensure safety of food, drug for human and animal, medical devices, and the safety of biological and chemical substance as well as electronic devices that are related to human health. The main purpose of the SFDA establishment is to regulate, oversee, and monitor food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether the products are imported to the country or locally manufactured. The authority is responsible for monitoring and/or testing activities in the SFDA or other agency’s laboratories. Moreover, the Saudi FDA oversees consumer’s awareness on all matters related to food, drug and medical devices and all other products and supplies.
Medical Device manufacturers who wish to place
their medical devices and IVD products in the Saudi market must first
get the Medical Device Marketing Authorization (MDMA) approval from the
Saudi Food & Drug Authority ‘’SFDA’’ through their Saudi ‘’Authorized
Representative’’ to be able to ship, sell or distribute those
products.
It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose for Manufacturers & Distributors
Strategically placed, we are able to provide services all around Saudi Arabia and beyond.
