Jul 16, 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

Regulatory requirements of Medical Devices in MENA countries

As healthcare spending continues to rise in the Middle East and North Africa (MENA), this region is becoming a key growth target for medical device manufacturers. One of the main challenges companies face in the region is navigating the non-harmonised regulatory landscape which contains different systems, requirements and procedures. Having a solid regulatory strategy in the region will require an in depth knowledge of the regulations and can open up a growing market.

Medical Devices - SIPS MENA

Azerbaijan, Timor-Leste, and Tonga have regulations for pharmaceutical drugs. There may be certain drug regulations that may apply to your medical device. For Botswana, Burkina Faso, Chad, Comoros, Grenada, Marshall Islands and the Central African Republic, there is insufficient data to determine if any medical device regulations exist. Many of the countries may either require an import permit and/or notification to the local Ministry of Health.

Overview of Regulatory Guidelines for Medical Devices

In some countries medical devices are regulated as drugs and in other countries there are special regulations for medical devices. Medical devices can in turn be regulated as one group or regulated separately, usually as one of the subgroups. In Europe general medical devices are divided into non invasive devices, invasive devices and active devices. An active medical device is a device that requires a

Medical devices | European Medicines Agency

Conformity Assessment bodies must fulfill requirements of EN45000 series and ISO/IEC 17025. Medical Device Registration Guideline, 4.1, p. 17. Pre-marketing / procedure: Medical device companies must undertake conformity assessment according to essential principles. In some cases, depending on the class of the device, technical documentation and approval of the foreign notified body may be ...

An introductory guide to the medical device regulation ...

The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope of EMA’s activities and should be read in alignment with the new Regulations (EU) 2017/745 on medical devices ...

ASEAN Medical Device & Pharmaceutical Regulations - CSDT, ACTD

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

South Africa Medical devices regulatory systems at country ...

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 ...

Medical devices and the Middle East: market, regulation ...

There is an article discussing countries with minimal medical device requirements at regdesk. It is titled "List of Countries with NO Formal Regulatory Approval Process" Last edited by a moderator: Mar 3, 2017. Likes: Ronen E. Ronen E Problem Solver. Staff member. Moderator. Mar 3, 2017 #9. Mar 3, 2017 #9. MMBer said: There is an article discussing countries with minimal medical device ...

New Medical Technology Regulations - MedTech Europe

Our internal and external experts possess extensive experience in Middle East & North Africa (MENA) countries regulatory requirements for best result achievement. - Pharmaceuticals - Biologics and biotechnology - Medical devices - Nutraceutical products - Cosmetics - Veterinary products - API products. We are proud our clients. Clients Feedback. Wafa Al-Kalouti . Regulatory & Business ...

Guide to the regulation of medical devices

Classification of medical devices from regulatory view point: Medical devices may be classified as per their medical utility or technical design and manufacturing aspects. However, regulatory authorities around the world have classified them based on their safety requirements and standards of quality to be set. Several criteria are considered ...

PMDA Medical Device Registration and Approval in Japan

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 example all those little island nations or hunger/war ...

Medical Device Regulatory Intelligence, IVD ...

Learn your specific medical device compliance requirements in other countries and what their Market Access Readiness Index (MARI%™) scores are for each market. Match. Match your existing compliance data with local registration requirements in your country of interest. Find out when your medical or IVD device approval, renewal, transfer or amendment will be completed. Update. Update your ...

Overview of Regulatory Requirements: Medical Devices ...

However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in ...

List of countries considered as Stringent Regulatory ...

country seeking to develop its regulatory capacity. Acknowledgements Regulation of medical devices: a step-by-step guide was prepared by Alan Kent, WHO Consultant. Technical review was carried out by Adham Ismail, WHO Regional Office for the Eastern Mediterranean, with contributions from the following WHO headquarters staff: Lembit Rago, David Wood, Irena Prat, Claudia Alfonso, Mike Ward ...

Medical Device Single Audit Program [MDSAP] | U.S., Canada ...

Based on the Council of Ministers resolution no. (181) issued on 18/6/2007, that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of director’s decision no. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law ...

Medical devices: how to comply with the legal requirements ...

Do overseas countries have regulation on medical devices? Many regions and countries like Australia, Canada, European Union, Japan and the United States of America already have their own systems for the control of medical devices. Asia-Pacific countries such as China, Indonesia, Malaysia, Philippines, Singapore, South Korea and Thailand also operate their own systems to regulate medical ...

Medical devices and the Middle East: Market, regulation ...

Medical Devices Regulations. SOR/98-282. FOOD AND DRUGS ACT. Registration 1998-05-07. Medical Devices Regulations. P.C. 1998-783 1998-05-07. His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3(3), 30(1) and 37(1) Footnote a of the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations.

MEDICAL DEVICES Guidance document Classification of ...

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

New EU Medical Device Regulations - HPRA

In Europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the product’s safety & performance. To maintain patient safety the EU introduced the Medical Device Regulation (MDR) transforming and modernising the older Directives. Whether you are new to regulatory affairs, the MDR or are branching out from other areas of the wider medical device ...

Regulatory Requirements for Medical Equipment

Medical device regulations in Paraguay are set forth by the Direccion de Viglancia Sanitaria del Ministerio de Salud Publica y Bienestar Social (MSPBS). Medical devices in Paraguay are not classified. However, since Paraguay is a member of Mercosur, all medical devices intended to be marketed in Paraguay should be compliant with MSPBS ...

Philippines Medical Device Registration - FDA Approval

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. Improving the safety of medical devices. The regulations will improve the safety of medical devices in two ways:

Medical Device Approvals in Brazil: A Review and Update

Devices, including medicinal and those of biological origin; Kingdom of Saudi Arabia. In the Kingdom of Saudi Arabia (KSA), you can begin the medical device registration process if your company has regulatory approval from one of the founding members of the Global Harmonization Task Force (GHTF). The five founding members are: 1) the USA ...

THE SOUTH AFRICAN MEDICAL DEVICE INDUSTRY - FACTS

Understanding the regulatory requirements for medical devices in India. India represents a compelling market opportunity for global medical device manufacturers, with the majority of medical devices sold in India imported from other countries. Substantial growth for the Indian medical device industry is expected to be driven by the current low per person spending rate for medical devices ...

Do you know the requirements and your responsibilities for ...

This document explains the specific regulatory requirements for clinical investigations of medical devices. Applicants are required to follow this information when wishing to perform an investigation in a centre in Denmark. Pursuant to the Ministry of Interior and Health’s Act no 1046 of 17 December 2002 for medical devices, the Ministry of Health and Prevention’s Executive Order No. 1263 ...


Regulatory Requirements Of Medical Devices In Mena Countries



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Regulatory Requirements Of Medical Devices In Mena Countries