Waqas Ali Khan

Article on SMDR by Waqas Ali Khan Date:- Day: Saturday Page |1 “ SAUDI MEDICAL DEVICES REGULATION ” The term “medical devices” inncludes everything from highly sophisticated computerized medical equipment down to sim mple wooden tongue depressors. Like medici cines and other health technologies, they are ess ssential for patient care – at the bedside, at thhe rural health clinic or at the large, specializedd hospital. Medical devices include a wide rang nge of products varying in complexity and app pplication. Examples include: tongue depresssors, medical thermometers, blood sugar met meters, total artificial hearts, fibrin scaffolds, ste tents and X-ray machines. Yet many countries lack access ss to high-quality devices and equipment that arre appropriate for their specific epidemiologiical needs. Surprisingly, regulatory controlss for medical devices are scarce in the develop oping world, even though implementation of nat ational medical device regulations will often adddress the very issues raised in countries as major m concerns for patient safety. The Kingdom of Saudi Arabia is one of the largest markets for medical devices and associated products in the Middle East region. region. As part of the Gulf Cooperation Council (GCC, also known as the economic union of the six Arab states), Saudi Arabia has experienced extraordinary growth, rowth, primarily due to its hydrocarbon hydrocarbon-based economy. The results of this rapid progress can be seen not only in the increasing number of the Saudi population but also in healthcare expenditure. The national regulatory authority agencies responsible for healthcare ealthcare in Saudi Arabia are the Ministry of Health (MoH) & Saudi Food & Drug Authority (SFDA). highest-level level supervisory board that oversees all aspects The Ministry of Health (MoH) is the highest of the Kingdom’s healthcare services, and is responsible for buil building ding hospitals & health care centres, as well as issuing and enforcing regulations for the practice of medicine and pharmacology. The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. The Medical Device Sector has three responsibilities: legislative, executive, and surveillance. As to the first, the sub sub-agency agency sets mandatory specifications for medical devices, IVDs, and radiation radiation-emitting emitting electronic devices; set good manufacture practices; issues policies and procedures for medical device testing; set requirements for medical devices marketing and distribution, and provides advertising regulations. The Authority objective is to ensure the safety of food and drug for man and animal, and safety y of biological and chemical substance as well as electronic products. The main purpose of the Saudi Food and Drug Authority establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing Regulatory Affairs & Quality Operations Professional Pro (Pharmaceuticals) | RA Freelancer & Consultant Email:-&--Signature: Article on SMDR by Waqas Ali Khan Date:- Day: Saturday Page |2 “ SAUDI MEDICAL DEVICES REGULATION ” activities can be conducted in the SFDA or other agency’s laboratories. Moreover, the SFDA is in charge of consumers’ awareness on all matters related to food, drug and medical devices and all other products and supplies. Saudi Food and Drug Authority has issued a number of guidelines to assist an organization operating in the field of medical devices to understand its obligations under the Interim Regulation and the Implementing lementing Rules. The Saudi Food and Drug Authority (SFDA) regulates medical devices and IVDs sold and distributed in Saudi Arabia. For most devices, Medical Device Marketing Authorization (MDMA) approval from the SFDA is required before placing a product on o the market. MDMA is an electronic system aims to authorize medical devices after they comply with the Medical Devices Interim Regulation (MDIR) and in particular to the implementing rule MDS-IR6 IR6 for Medical Device Marketing Authorization (MDMA). The system syst allows local manufacturers and overseas manufacturers authorized representatives to apply electronically for medical devices marketing authorization which permits relevant medical devices to be placed on the market of the Kingdom of Saudi Arabia when sa satisfied tisfied that the applicant has provided all the required information for market authorization. The SFDA meticulously reviews MDMA applications, so prepare your submission carefully to ensure timely approval. Registration to regulate in Saudi Arabia require requiress prior 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. You must also appoint a Saudi Arabia Authorized Representative if you do not have an office or entity in Saudi Arabia. Your Authorized Representative must obtain an Authorized Representative License, which is renewable on an annual basis, to legally represent you in the KSA(Kingdom ngdom of Saudi Arabia). Your KSA Authorized Representative is also responsible for submitting all application documents to the SFDA to register your device. Medical device manufacturers without a legal entity in the Kingdom of Saudi Arabia (KSA) must appoi appoint a Saudi Arabia Authorized Representative who serves as a liaison between you and the Saudi Food & Drug Authority (SFDA), They actually protect your intellectual property and allow you to control your distribution options. Manufacturers wishing to place goods in the Saudi market must now provide the Saudi Food & Drug Authority (SFDA) with documentation that demonstrates that the device is authorized to be placed on the market. The SFDA already introduced the Medical Devices Interim Regulatory Affairs & Quality Operations Professional Pro (Pharmaceuticals) | RA Freelancer & Consultant Email:-&--Signature: Article on SMDR by Waqas Ali Khan Date:- Day: Saturday Page |3 “ SAUDI MEDICAL DEVICES REGULATION ” Regulation (MDIR), part of which is the Medical Device Marketing Authorization (MDMA) system which mandates the granting of a Market Authorization License for all Medical Devices imported into the Kingdom. The SFDA’s online system contains the regulations, ulations, guidance documents and more recently an additional guidance document (for version 1 of the MDMA database) that has been specifically developed by the SFDA in conjunction with the SFDA Designated Conformity Assessment Bodies of which there are currently five (BSI, COSMOS, TUV SUD, SUD TUV Rheinland, SGS). The guidance documents have been developed in the light of the experience already gained following the introduction of this legislation into the Kingdom as the SFDA seek to enforce and achieve the obj objective of ensuring a regulated market for medical devices in the Kingdom of Saudi Arabia. Furthermore, The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for con conducting clinical investigations in the country. According to the guidance, all clinical investigations planned to take place in the KSA must obtain SFDA approval; all investigational medical devices involved in such studies must also be approved by the SFDA before legal entry into the KSA. The he guidance includes an application manufacturer and/or sponsors must fill out and submit to the SFDA in order to obtain approval to conduct clinical investigations in the KSA. Information to be included in the application ation include technical and regulatory data regarding the investigational medical device; proposed clinical investigation design and sites in the KSA; and contact details for the device manufacturer and/or clinical investigator. Manufacturers and investigators tors must also submit labeling information for their investigational devices, as well as plans for reporting progress on their studies once underway. underway Below are the Saudi Medical Devices Regulation in summarized form for better understanding / further clarification fication; AGENCY: All medical devices are regulated by the Medical Device Sector as part of the Saudi Food & Drug Authority (SFDA). CLASSIFICATION OF MEDICAL DICAL DEVICES: DEVICE Risk Classification Examples Class Low Risk Medium Risk High RIsk Stethoscope, breath breath-alcohol test system Protein test systems, syringes External/internal pacemakers, plasma warming device Class I Class II, IIa, IIb Class III,IV Regulatory Affairs & Quality Operations Professional Pro (Pharmaceuticals) | RA Freelancer & Consultant Email:-&--Signature: Article on SMDR by Waqas Ali Khan Date:- Day: Saturday Page |4 “ SAUDI MEDICAL DEVICES REGULATION ” PREMARKET APPROVAL P PROCESS: Before selling in Saudi Arabia, device must be authorized in reference country (Australia, Canada, Europe, Japan, or USA) Appoint representative in Saudi Arabia. Representative must fill out an Authorized Representative (AR) contract, which will be reviewed by the SFDA. Submit Medical Device Marketing Authorization (MDMA) application through AR. This application will include: device labeling, IFU, and promotional materials in both English and Arabic. It also needs to include documentation of approval in reference markets and certification in English. Fo Forr application fees and Review times, you can visit https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/fees.aspx SFDA reviews application and then Conformity Assess Assessment ment Body (COB) performs a rigorous technical review of application. Often time’s applications go through multiple rounds of this and questioning. CAB will make recommendation to SFDA who will make the final decision. If approved SFDA will issue an MDMA certificate. ce POST MARKET: Validity : Class I (Valid Valid for three years years) Other Classes: Valid for the remaining validity period of referential country registration or three years, whichever comes sooner. sooner Regulatory Affairs & Quality Operations Professional Pro (Pharmaceuticals) | RA Freelancer & Consultant Email:-&--Signature: Article on SMDR by Waqas Ali Khan Date:- Day: Saturday Page |5 “ SAUDI MEDICAL DEVICES REGULATION ” CONCLUSION The significant medical devices market size in Saudi Arabia, information regarding policies and regulations for medical devices market access is highly workable able and should be more effective time to time.. The aim of this article from Bio-standards.com service as solution for manufacturers, importers and distributors distributors, is to provide a systematic review on market access policies and regulations in Saudi Arabia, to allow safe and timely access to medical technology. The market access schemes of SFDA are relatively structured. However, some expert review, recommendations, collaboration with different countries regulatory bodies to make more comprehensive policy framework in Saudi Arabia for better and secure access to medical technology. Regulatory Affairs & Quality Operations Professional Pro (Pharmaceuticals) | RA Freelancer & Consultant Email:-&--Signature: