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Steps to Register a Medical Device in the USA
Bringing a medical device to market in the United States is a major milestone but it’s also a highly regulated process. The U.S. Food and Drug Administration (FDA) oversees medi...
June 2025 Newsletter (English)
We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition:...
In Vitro Diagnostic (IVD) Device Registration in South Korea
As South Korea continues to be a key player in the Asia-Pacific diagnostics market, manufacturers looking to commercialize their in vitro diagnostic (IVD) devices must navigate th...
Technical Documentation Requirements for MFDS Medical Device Registration
When entering the South Korean medical device market, manufacturers must adhere to the Ministry of Food and Drug Safety (MFDS) guidelines. One of the most critical elements in thi...
How to Appoint a Local Authorized Representative in South Korea?
If you're a foreign manufacturer looking to place your medical device on the South Korean market, one of the first regulatory steps is appointing a South Korea authorized represen...
Post-Market Surveillance for Medical Devices in South Korea
In South Korea, post-market surveillance (PMS) is a critical component of medical device regulation. The Ministry of Food and Drug Safety (MFDS) enforces stringent requirements to...
Why You Need an Authorized Indian Agent for CDSCO Registration
Entering the Indian market with medical devices requires a clear understanding of the CDSCO registration process. One of the key requirements for foreign manufacturers is to appoi...
6 Challenges in CDSCO Registration & How OMC Solves Them
Getting medical devices approved for the Indian market involves more than just paperwork. CDSCO follows strict guidelines, and if you're not familiar with how it works, the proces...
Medical Device Grouping in India
As India improves its rules for medical devices, it’s important to know how products are grouped when they are registered. The Central Drugs Standard Control Organization (CDSCO...
New MIR Form 7.3.1 Accepted by Swissmedic: Key Updates for Medical Device Manufacturers
On May 5, 2025, the European Commission released version 7.3.1 of the Manufacturer Incident Report (MIR) form used for reporting serious incidents involving medical devices. This...
CDSCO Fee & License Fee for Medical Device Registration
Entering the Indian medical device market requires compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. A crucial aspect of this compliance is unde...
CDSCO Releases Addendum Clarifying Key Aspects of Medical Devices Rules
The Central Drugs Standard Control Organization (CDSCO) has issued a new addendum (No. 0152), dated April 3, 2025, This article provides additional clarity on several regulatory r...
Top 7 Challenges in UAE Medical Device Registration(and Solutions)
You’ve got a medical device ready for the UAE market—everything from quality certifications to technical documentation is in place. But just as you start the registration proc...
April 2025 Newsletter (English)
We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition:...
8 Requirements for Post-Market Surveillance of Medical Devices in Saudi Arabia
Post-market surveillance (PMS) plays a critical role in maintaining the safety, quality, and performance of medical devices available in Saudi Arabia. The Saudi Food and Drug Auth...
What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?
In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post...
e-IFU Guidelines for Medical Devices in Saudi Arabia
Imagine you're a healthcare professional in Riyadh, mid-procedure, and you urgently need access to a device's instructions. Instead of flipping through a bulky printed manual, you...
Saudi AR License Renewal Fees & Process for Medical Devices
Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulato...
Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation?
In the medical device industry, the terms clinical study and clinical evaluation are often used interchangeably—yet they serve very different purposes. Understanding the distinc...
What Is Medical Translation and Why Is It Critical?
When it comes to healthcare, there’s no room for miscommunication. Whether it's medical research, pharmaceutical products, clinical trials, or regulatory documentation, informat...
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
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
Pharma Blogs
Medical Device Registration in UAE
UAE Medical Device Registration: A Step-by-Step Guide The UAE's healthcare sector has grown significantly in recent years, leading to an increased demand for medical devices. To ensure patient safety, regulatory authorities in...
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 Au
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
Saudi Arabia is a growing hub for the medical device market, presenting tremendous opportunities fo
Medical Device and IVD Blogs
Saudi AR License Renewal Fees & Process for Medical Devices
Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring ti
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
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Quick Contact
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.
Quick contact
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