Importance of the Standards
A standard is a document that provides rules, principles, products characteristics or the associated production methods and processes, which is not mandatory. Standards may include or be limited to the terms, codes, product packing or labeling requirements and specific production or testing methods.
The purpose of the standard is to facilitate the exchange of goods and commodities, improve safety and health, protect life ,environment, consumer and product, facilitate communication and discussion between the parties involved in industrial or commercial activities, reduce costs and increase product competitiveness in the local & international markets and remove technical obstacles encountered by trade.
To achieve this principle, many countries and international organizations worked on standardization of the basic requirements through developing and issuing of standards for products and methods of their production. Some of these standards are related to medical devices and are issued by international organizations such as:
- International Organization for Standardization - ISO
- International Electrotechnical Commission - IEC
- International Organization of Legal Metrology - OIML
SFDA’S role in the field of medical devices standards
Based on the royal decree No (M/6) dated 25/1/1428H, approving SFDA regulation, providing in Article (3) that: “ The prime purpose of SFDA is to regulate and control food and drug through development of mandatory and non-mandatory standards for food, drug and products falling under SFDA’s mandate and to control and test the same in its laboratories..Etc.”. Also, paragraph 3 of article 5 – “SFDA Regulatory Mandate”, included that:” SFDA shall undertake the development of mandatory Standard for food, health bio-products, cosmetics, plants & herbs of medical alleges,, laboratory & diagnostic indicators, medical devices and electronic devices affecting people’s health and pesticides”.
The tasks of development, issuance and approval of mandatory and non- mandatory standards of food, feed, pesticides, tobacco & tobacco products, cosmetics, medical devices and test methods were transferred from Saudi Standards, Metrology and Quality Organisation (SASO) to SFDA.
In addition, SFDA, represented by medical devices sector, participates in the technical committees meetings related to medical devices, emerging from regional, and international standardization organizations such as GCC Standardization Organization (GSO), IEC and ISO.
Also, the medical devices sector participates in regional and international standards project related to medical devices based on its experience and scientific background in this field.
