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Common Challenges in Medical Device Registration in China and How to Overcome Them
18Feb 2025
China, Trending Now admin Comments: 0

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 common challenges and how to overcome them is crucial for a successful market entry. This blog highlights key obstacles and provides actionable solutions to streamline the process. ...
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18Feb 2025
China, Blogs, Trending Now admin Comments: 0

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 must comply with stringent regulatory requirements to ensure safety, efficacy, and compliance.   The Centre for Medical Device Evaluation of NMPA (CMDE) shall be responsible for the application for clinical trials of medical devices requiring clinical trial approval, and the technical evaluation of the registr...
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UAE Medical Device Registration Process
16Jan 2025
Blogs, Medical Device, Registrations, Trending Now admin Comments: 0

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 the UAE have laid down strict guidelines for registering medical devices. This process helps ensure that medical devices sold in the UAE are safe, effective, and high-quality. Whether you are a manufacturer or an importer, understanding the UAE medical device registr...
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SFDA Fees for Medical Devices 
15Jan 2025
Blogs, Medical Device, SFDA, Trending Now admin Comments: 0

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 fee structures and timelines based on device classifications, application updates, and authorized representative requirements.   Timelines, and Requirements for SFDA Fees for Medical Devices 1. Device Classification and Fees  SFDA fees for medical device marketing authorization (MDMA) vary by risk classif...
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sfda classification
14Jan 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

Complete Guide to SFDA Classification in Medical Device & MDMA in Saudi Arabia  Bringing a medical device to market in Saudi Arabia involves more than just innovation; it requires a clear understanding of the Saudi Food and Drug Authority (SFDA) regulations. In this blog, we will cover the SFDA classification system, the process of obtaining Medical Device Marketing Authorization (MDMA), ensuring compliance with Saudi Arabia medical device regulations and how the Medical Device Establis...
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Saudi Authorized Representative
13Jan 2025
Medical Device, Blogs, SFDA admin Comments: 0

Saudi Authorized Representative

Saudi Authorized Representative for Medical Devices  Medical device manufacturers aiming to enter the Saudi market must comply with the Saudi Food and Drug Authority (SFDA) regulations. For companies without a legal entity in the Kingdom of Saudi Arabia (KSA), appointing a Saudi Authorized Representative (Saudi AR) is a mandatory requirement. This post explores the responsibilities of a Saudi AR and the advantages of working with medical device regulatory consultants in Saudi Arabia.  Why...
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Medicinal Products for Human
30Sep 2024
Blogs, General Information admin Comments: 0

Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers. The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Reg...
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Global Labelling Requirements
05Feb 2024
EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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FSCA
05Feb 2024
Regulations, Blogs, Swiss admin Comments: 0

Field Safety Corrective Action (FSCA) – Swiss

What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action (FSCA). The manufacturer is required to take action to remove or limit the risk of the recognised dangers. If a medical device malfunctions in Switzerland, the manufacturer is required to undertake an FSCA and Swissmedic keeps track of all FSCAs regarding medical equipment sold in...
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05Feb 2024
EU, Blogs, Regulations Cubicdesignz Comments: 0

EU Requirements for Translations

Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn’t strictly followed up until MDR was brought in place. The European Union’s language requirements information can be found in Article 41 and Annex 1 (Chapter 3) of the EU MDR. Language requirements: EU Requirements for Translations As per MDR 2017/745, the information provided with medical devices needs to be tr...
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