Jul 06, 2020

Regulatory Requirements Of Medical Devices In Mena Countries

regulatory requirements of medical devices in mena countries

Regulatory requirements of Medical Devices in MENA countries Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels „Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn Vorgelegt von Dr. Fatemeh Samadi aus dem Iran Bonn, Februar 2015

Medical Device Regulations In The MENA Region - Online Academy

5. Clinical Evaluation of Medical Devices 5.1 MEDDEV Guidance for clinical evaluation. 5.2 Clinical investigation of medical devices. 5.3 EN ISO 14155 Parts 1 and 2. 6. Medical Device Regulation in the United States: 6.1 Introduction & Definitions 6.2 US Classification. 6.3 Establishment registration and medical device listing.

Medical Devices - Middle East & North Africa Regulatory ...

Medical Device Regulations in the Middle East and North Africa Training Course: face to face & live webinar . This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

List of Countries without Formal Regulatory Approval Process

The Middle East and North Africa (MENA) is a region encompassing approximately 22 countries and accounting for approximately 10% of the world’s population with an average increase of 3.5% per year. Since the MENA owns around 60% of the world’s oil reserves and 45% of the world’s natural gas reserves, it became an important source of ...

Global Regulatory Requirements for Medical Devices

Under the Ministry of Health, the Medical Device Authority is the government organization tasked with overseeing Malaysia medical device regulations. The legislations that regulate the manufacturing and distribution of medical devices in Malaysia are the Medical Devices Act, the Medical Device Authority Act, and the Medical Device Regulations, all released in 2012.

Oman Medical devices regulatory systems at country level

The International Medical Device Regulators Forum (IMDRF) is a group of medical device regulators from around the world that have voluntarily come together to harmonize the regulatory requirements ...

Challenges and latest regulations about medical devices in ...

Notes: San Marino does not have a regulatory framework. There is a framework law for the transposition o f EU Directives and Regulations. As of now, San Marino asks San Marino companies that export products to register their medical devices in Italy or another EU country. National Regulatory Authority National Regulatory Authority present: No ...

Overview of Regulatory Guidelines for Medical Devices

1 Regulatory requirements of Medical Devices in MENA countries Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn Vorgelegt von Dr. Fatemeh Samadi aus dem Iran Bonn, Februar 2015 I

Overview of Device Regulation | FDA

SFDA regulatory guidelines are based on preexisting approval in one of the five founding member nations of the Global Harmonization Task Force (GHTF; replaced by the International Medical Device Regulators Forum as of February 2011, including Australia, Canada, the United States, the European Union, and Japan), an organization established in ...

Medical Devices Regulations | NEWS

I have recently written three reports on the U.S. Food and Drug Administration's regulation of medical devices that summarize and provide documentation for the views I hold regarding the U.S. regulatory system.(1-3) The following report will present eight conclusions I have reached, in the form of comparisons of the U.S. regulatory system with the corresponding systems in Europe, Canada, and ...

Countries that require minimal Medical Device Registration

This eLearning series of medical devices training courses covers country-specific requirements for Australia, Brazil, Canada, Japan and the United States. These computer-based courses offer highly interactive instruction on each jurisdiction’s legal and regulatory framework, premarket pathways and requirements, and postmarket regulations.

Kuwait Medical Device Registration and Approval | LICENSALE®

Comparative Overview of Medical Device Regulatory Systems. David Jefferys, a medical device expert and senior vice president for global regulatory, health-care policy, and corporate affairs at Eisai Europe, Ltd., provided an overview of European device regulations and discussed some of the key procedures in Japan, China, and India and how they differ from current operations in the United States.

2017 GCC Medical Devices Market Snapshot - Reciprocus

Robert Lee MS, RAC, CQA Country of Origin means the country of origin for the owner of the medical device design. For example, if the medical device owner is based in US and has manufacturing facility in China, the country of origin is US. C I don't have a list of countries that require country of origin per se, but there are many that do.

Medical devices: EU regulations for MDR and IVDR - GOV.UK

Some Asian countries have elaborate medical devices regulatory systems, including a lot of good info available online, but I don't know if that's actually relevant to you. With regards to the countries you listed, I know nothing about their regulatory requirements, and honestly, I think most of them don't have any such system in place (for ...

Medical Devices Regulation - Flowchart - MedTech Europe

<p>One common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards. This article explains the method, starting with standards from the International Organization for Standardization (ISO) adopted and recognized in various regulatory systems. The article uses ISO 13485:2003 and ISO 14971:2007 as illustrations.</p>

Which Countries Require CE Marking of Medical Devices ...

To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.

Medical Device Regulations in Germany | RegDesk | Professional

Can I ask please, Since am new to medical devices. If a medical device will be imported to the US shall the label mention the country of origin. and if so, we are an Australian company, our contract manufacturer is located in Taiwan. so is the statement "product of Taiwan" or "product of...

Medical Device Registration in Saudi Arabia

List of countries considered as Stringent Regulatory Authorities (SRA) from 1st July 2009. The national drug regulatory authorities which are members or observers or assodiates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are considered as Stringent Regulatory ...

Medical devices | European Medicines Agency

Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S ...

Japan Medical Device Registration - Shonin Approval

Medical devices and in vitro diagnostic (IVD) devices are regulated by the South African Health Products Regulatory Authority (SAHPRA), a semi-autonomous body established by the National Department of Health in 2016. In addition to devices, the Authority also regulates medicines (pharmaceutical and supplements), and cosmetics.

Medical Software Regulatory Requirements for South America ...

MEDICAL DEVICE REGISTRATION IN AUSTRALIA. The Therapeutic Goods Administration (TGA) – the regulatory firm for medicines, medical devices, blood, and tissues in Australia – is the segment of the Department of Health and Ageing.. Australia, formally the Commonwealth of Australia, is a sovereign country including the mainland of the Australian continent, the island of Tasmania and many more ...

Placing Medical Devices in Portugal -- MEDICA - World ...

These regulations fall under the Consumer Protection Act 1987 and ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose. The ...

Republic Of Georgia Medical Device Regulations for IVD

Regulation 2017/745, derived from European Directives 90/385 (active implantable devices) and 93/42 (medical devices), was to take effect on 26 May 2020. The public authorities have granted a one-year reprieve because of the COVID-19 health crisis which has disrupted many organizations.

CFDA Releases “Amendments to the Regulations on the ...

Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017 the Medical Device Regulation (MDR) replaced the MDD. Medical devices vary in both their intended use and indications for use.

Restricted Substances under the New Medical Devices Regulation

Regulatory Requirements for Medical Devices in China As the most populous country in the world, China’s medical device market has maintained a double-digit growth for more than 10 years. While there may be some economic challenges and uncertainties in the near future, due to its market size and aging ...


Regulatory Requirements Of Medical Devices In Mena Countries



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Regulatory Requirements Of Medical Devices In Mena Countries