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A Strategic Guide to Pharmaceutical Product Registration in Angola by OMC Medical
As one of the largest economies in Central Africa, Angola is a strategic market for pharmaceutical companies. Gaining INABEC Drug Approval is the critical gateway to this opportun...
A Strategic Guide to Pharmaceutical Product Registration in Senegal by OMC Medical
Senegal represents a pivotal pharmaceutical market in West Africa. For pharmaceutical companies looking to introduce their medicines, understanding and complying with the regulati...
The 2024 NMPA Fee Catalogue: A Clear Cost Guide for Drug and Device Registration in China
Budgeting for your market entry into China's pharmaceutical and medical device industry requires precise financial planning. The National Medical Products Administration (NMPA) ad...
Demystifying China’s Medical Device Registration Fees: A Guide for Class III and Imported Products
Navigating the financial aspects of your medical device registration in China is as critical as the technical dossier. Understanding the NMPA's fee structure for Class III medical...
Navigating the NMPA Registration Fee: A Critical Step to Market Approval in China
Securing market approval for your drug or medical device from China's National Medical Products Administration (NMPA) is a detailed process where every step counts. One of the mos...
Registering Medical Devices in Angola: A Guide by OMC Medical
Angola's growing healthcare sector presents a promising frontier for medical device manufacturers. However, market entry is strictly regulated by the National Institute for Health...
Overview of the Medical Device Registration Process in Ghana
Expanding your medical device business into Ghana requires a clear understanding of the country’s regulatory framework governed by the Ghana Food and Drugs Authority (FDA). ...
Registering Medical Devices in Senegal: A Guide by OMC Medical
Navigating ANSSA: Your Roadmap to Senegal Medical Device Registration The Senegalese healthcare market is rapidly expanding, offering significant opportunities for manufacturer...
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...
OMC’S Overview and Key Changes (The “New Pathway”)
South Africa has transitioned from the old Medicine Control Council (MCC) system to a new, risk-based framework under SAHPRA. This new pathway, which became fully effective, is ba...
Comprehensive Guide to MFDS Fee Structure for Medical Device Approval (All Classes)
Publication Date: 12/09/2025 Department: Medical Device Safety Bureau, Ministry of Food and Drug Safety (MFDS) To ensure transparency and facilitate the medical devi...
Understanding Uzbekistan’s Medical Device Classification System
Uzbekistan’s healthcare market is growing, and so is the demand for safe, high-quality medical devices. But before your product can reach hospitals, clinics, or patients, it mus...
Post-Market Obligations After NMPA Approval: Maintaining Compliance in China
Securing NMPA approval for your medical device is a significant achievement, but it’s just the beginning. In China, compliance doesn’t end at approval. Once your product is on...
Clinical Evaluation Report (CER) Requirements for Medical Devices in China
When registering a medical device in China, the Clinical Evaluation Report (CER) is one of the most important parts of your submission to the National Medical Products Administrat...
Global Regulatory Consulting Fee Schedule – Effective Q3 2025
Document Purpose: This Global Regulatory Consulting Fee Schedule provides the standardized hourly rates for OMC Medical’s regulatory affairs consulting services. Rates are ca...
Detailed process on Bolivia registration and timelines
Overview & Key Authority The regulatory process in Bolivia is overseen by the National Authority of Medicines and Health Technologies (Agencia Nacional de Medicamento...
Regulatory Overview: Medical Device Registration Process and Timeline in the Bolivarian Republic of Venezuela
This article provides a comprehensive overview of the mandatory medical device registration process with the National Center for Health Technology and Equipment (Centro Nacional d...
Comprehensive Guide to Medical Device Registration Costs in Paraguay
The regulatory landscape in Paraguay requires a clear understanding of the investment involved. At OMC Medical, we believe in transparency. The following cost breakdown prov...
Medical Device Registration Costs & Timelines in Australia: What to Expect (2025 Update)
If you are planning to supply medical devices in Australia, understanding the Therapeutic Goods Administration (TGA) medical device registration costs and timelines is essential f...
Process to Register Medical Device Registration in Australia
If you’re planning to supply a medical device in Australia, you must comply with the Therapeutic Goods Administration (TGA) requirements and have your product included in the Au...
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 requiring input from au
Pharma Blogs
A Strategic Guide to Pharmaceutical Product Registration in Senegal by OMC Medical
Senegal represents a pivotal pharmaceutical market in West Africa. For pharmaceutical companies looking to introduce their medicines, understanding and complying with the regulations set by the National Agency for Health Safety (...
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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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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