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How to Ensure Your Medical Device Meets China’s Regulatory Standards?
China’s medical device market is one of the largest and fastest-growing in the world, making it an attractive destination for manufacturers. However, navigating the complex regu...
China’s Medical Device Regulatory Framework and NMPA Guidelines
China has emerged as one of the largest and fastest-growing markets for medical devices, making regulatory compliance essential for manufacturers looking to enter this competitive...
How to Ensure Medical Device Safety in China? Quality Control Standards
China’s medical device market is one of the largest and fastest-growing in the world. However, ensuring compliance with the country’s strict quality control standards is essen...
Common Challenges in Medical Device Registration in China & How to Overcome Them
Navigating the medical device registration process in China can be complex due to stringent regulatory requirements, evolving standards, and regional variations. Understanding com...
Step by Step Process in Medical Device Registration China
Registering medical devices in China is a complex and highly regulated process governed by the National Medical Products Administration (NMPA). Manufacturers seeking market entry...
January Newsletter 2025- Korean
Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our January Newsletter 2025. Stay informed about the most recent ad...
January Newsletter 2025- English
Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our January Newsletter 2025. Stay informed about the most recent ad...
Responsibilities of UK Responsible Person (UKRP)
To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person. The UK Re...
US FDA Draft Guidelines to Regulate AI-Enabled Medical Devices
The US Food and Drug Administration (FDA) has taken a significant step forward in addressing the growing integration of artificial intelligence (AI) in medical device development....
India Introduces Reclassification of 1178 Medical Devices
India has announced a significant update to its regulatory framework for medical devices, with the Central Drugs Standard Control Organization (CDSCO) reclassifying 1,178 medical...
SFDA Fees for Medical Devices
Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific...
How to Register Medical Devices in the Saudi Market?
6 Steps for Saudi Arabia Medical Device Registration Saudi Arabia is a growing hub for the medical device market, presenting tremendous opportunities for manufacturers worldwid...
December Newsletter 2024 – Chinese Simplified
We look forward to sharing the latest updates and insights in our December Newsletter 2024 – Chinese Simplified. What’s inside in December Newsletter 2024 – Chinese Simpl...
Medical Device Regulatory Recap 2024 by OMC Medical Limited
In 2024, OMC Medical Limited achieved remarkable milestones while adapting to significant regulatory developments, reinforcing its global presence. Regulatory Recap 2024 Key...
December Newsletter 2024 – Japanese
We look forward to sharing the latest updates and insights in our December Newsletter 2024 – Japanese What’s inside in December Newsletter 2024 – Japanese? The latest...
December Newsletter 2024 – Korean
We look forward to sharing the latest updates and insights in our December Newsletter 2024 - Korean What’s inside in December Newsletter 2024 - Korean? The latest informa...
December Newsletter 2024
We look forward to sharing the latest updates and insights in our December Newsletter 2024 What’s inside in December Newsletter 2024? The latest information on medic...
Regulations updates
Five minute reads
Arab Health Event 2025
OMC Medical Limited invites you to meet our team 𝑬𝒅𝒘𝒂𝒓𝒅 𝑪𝒉𝒆𝒏, 𝑵𝒊𝒌𝒐𝒍𝒐𝒂𝒔 𝑷𝒂𝒓𝒅𝒂𝒍𝒊𝒔 and 𝑪𝒉𝒊𝒅 𝑹𝒂𝒅𝒉𝒂𝒌𝒓𝒊𝒔𝒉𝒏𝒂...
Five Minute Reads
Cosmetic Blogs
The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU. UK Cosmetics Requirements &am
Cosmetic Regulatory Requirements in Finland complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements. Finnish Safety and Chemicals Agency (Tukes) In Finland
Cosmetic Regulatory Requirements in Luxembourg complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements specific to cosmetics. The regulation sets out stringent r
In Sweden, cosmetic products are regulated primarily under the framework of the European Union (EU) legislation, specifically Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safe
In the United Kingdom (UK), cosmetic products are regulated under the UK Cosmetics Regulation 2019, which governs the safety and marketing of cosmetic products. This regulation largely mirrors the European Uni
Cosmetic Regulatory Requirements in Belgium follows the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements for cosmetics. Federal Agency for Medicines and Health Products
Cosmetic Regulatory Requirements in France are regulated under European Union (EU) legislation, specifically Regulation (EC) No 1223/2009 on cosmetic products. The French National Agency for Medicines and Heal
Cosmetic Regulatory Requirements in Norway are regulated under the framework of the European Economic Area (EEA) agreement, which aligns Norwegian regulations closely with those of the European Union (EU). The
Spain follows the European Union (EU) regulations for cosmetics, primarily governed by Regulation (EC) No 1223/2009. This regulation ensures the safety and compliance of cosmetic products marketed within the E
Cosmetic Regulatory requirements in Denmark adheres to the EU regulation (Regulation (EC) No 1223/2009). The Danish Environmental Protection Agency (EPA) is the responsible authority for cosmetic regulations a
Italy adheres to the EU regulation (Regulation (EC) No 1223/2009). The Italian Ministry of Health oversees the regulation of cosmetic products in the country. Italian Ministry of Health In Italy, the ove
Poland regulates cosmetic products under the framework of the European Union (EU) legislation, specifically adhering to Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and
Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share simi
A Guide to Cosmetic Regulations in Saudi Arabia In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marke
eCTD-an overview In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development
The term “animal testing” refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer
Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from
Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and
by OMC Medical | Dec 13, 2023 | Cosmetics, EU Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from au
Pharma Blogs
Pharma Blogs
TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product&nbs
The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and effic
Territory Southeast Asia Official Language Indonesian/English Regulatory Authority
MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Reg
MoH Ministry of Health of Argentina MoH Website https://www.argentina.gob.ar/salud Regu
MoH The Ministry of Health and Social Protection. MoH Website https://shendetesia.gov.al
MoH Ministry of Public Health MoH Website https://moph.gov.af/en Regulatory Authority
A medical device’s intended use and inherent risks must be considered when determining its MDR cl
Technical documentation should contain details of the medical device in a clear, organized, readily
“Professional use” Test Kit – Procedure for registration in UK Novel Corona Virus Di
Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic informat
Ministry of Health Ministry of Health Regulatory Authority National Agen
A medical device’s intended use and inherent risks must be considered when determining its MDR cl
Navigating Medical Device Registration with Iraq’s Regulatory Authority: KIMADIA Guidelines and R
“Professional use” Test Kit – Procedure for Registration in UK Novel Corona Virus Diseas
South Korea has emerged as a significant player in the global medical device market, and its growth
The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products
6 Steps for Saudi Arabia Medical Device Registration Saudi Arabia is a growing hub for the medic
Medical Device and IVD Blogs
Switzerland Authorised Representative
Medical devices are regulated by the Swiss Agency for Therapeutic Product Manufacturer Responsibility 1.Ensuring medical devices are placed on the market is in accordance with the requirement of the
Switzerland Medical Device Regulations
Switzerland Market Situation As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA) No barrier-free access to the EU internal market
Swiss Regulation QA WHITE PAPER
MEDICAL DEVICE REGULATION UPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic) 2.
Switzerland AR Responsibilities
Obligations of the Switzerland AR Responsibilities 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep avail
Swiss Manufacturer Obligations
1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technicaldocumentation for the devices, to comply with the requ
Labelling Requirements – Swiss Authorized Representative
Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices
Nomenclature of Medical Devices
Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating huma
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If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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0044 7719761764
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