Companies, representatives of international pharmaceutical companies, pharmaceutical factories, private hospitals and medical centers can submit an application for registration of a medical device to the Department of Pharmacy and Drug Control of the Ministry of Health (MOPH). The market of the State of Qatar is quite small compared to other GCC markets, which are actually saturated with most types of products, such as the market leader of the “KSA” region and the business sector of the Gulf region “UAE”, which means that there is a great opportunity waiting for us to dominate the market and have a fairly large market share. Especially in the case of medical devices, due to the continuous innovation of medical devices, and do not forget the tenders, they are fundamental market players in all markets of the GCC countries. Managing medical registration regulatory activities in Qatar Mastering medical device registration in one of the most interesting parts of the GCC countries, a relatively small market mainly driven by the market, full of opportunities, let`s seize the opportunity and place our medical devices in the market of the State of Qatar. Earlier this year, the KFDA made some changes to its Medical Device Law. – All Class IV devices require summary technical documentation (STED) – All medical device registrants must comply with IEC 60601-1 3rd edition. – Changes to classification and grade rules. Qatar relies on pharmaceutical imports to promote free competition in the market and offers good opportunities for pharmaceutical and medical device manufacturers. To enter the region, manufacturers must obtain permits from the Ministry of Public Health, Pharmaceuticals and Drug Control. However, entry into the region challenges manufacturers with Qatar`s complex regulatory system.
The Ministry of Health of the United Arab Emirates (the Ministry) regulates medical devices in the United Arab Emirates. Medical devices are regulated in the UAE and require pre-market approval before being sold. Foreign manufacturers must register through an authorized representative to register devices. The Department follows the U.S. FDA or the EU Medical Devices Directive 93/42/EEC for the classification and evaluation of products. The foreign manufacturer must have an existing approval from at least one of the GHTF member countries. The devices are classified as Class I, IIa, IIb, III and active implantable devices. Regulator: Medical devices in Qatar are managed by the Ministry of Economy and Trade (MEC). Currently, medical devices do not require registration, but they do require an import permit, which must be obtained from a local authorized representative.
Class I medical devices do not require compliance with the requirements of the quality system. However, all Class II, III and IV devices require a quality system certificate (ISO 13485:2003). Health Canada only accepts quality system certificates issued by the Canadian Medical Devices Conformity Assessment System (CMDCAS). If you are a major exporter of medical devices, you need to be aware of global medical device regulations. The 2017-2021 Gulf Trench between Qatar and Saudi Arabia, the United Arab Emirates, Bahrain and Egypt severely affected the medical device trade. During this time, all transactions were suspended and, as a result, the industry slowed down significantly, opening market entry to new entrants. The Qatari government is offering a series of incentives to encourage more local businesses to enter this expanding market. In this course, I will take you on such an interesting journey with the Ministry of Health of Qatar to master our registration of medical devices there, practice regulatory issues, registration, renewal, variations with all their types, classification, on a case-by-case basis using concrete examples of practice. As I always keep my subject at the Pharmaceutical Academy that “It comes from practice” Currently, medical devices are not subject to registration in Kuwait. Only an import permit is required, which can only be obtained through a local representative.
The European Commission is the governing body responsible for developing legislation and directives on medical devices for the whole of the European Union. Although it is a competent authority, a government agency oversees the approval of medical devices in each EU country.