Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Get In Touch:

Youtube Linkedin
Call Us Now:
+44 2080667260 [email protected]

General Information

Home
Blog Standard
General Information
Medical Devices in South Korea
26Jul 2024
General Information admin Comments: 0

Import License Process for Medical Devices in South Korea: A Detailed Overview 

To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations.  Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is esse...
Read More
Medical Devices in South Korea
25Jul 2024
General Information admin Comments: 0

Labelling Requirements for Medical Devices in South Korea 

General Labelling Instructions for Medical Devices in South Korea  1.The label shall be printed in the ink, imprint, or stamp that cannot be easily erased, using Korean language in typefaces that are easy to read, such as the East Asian Gothic typeface.  1.1. Letters on the label shall not overlap with one another and shall also be in a color that is distinct from the background color, such as black letters on a white background.  2. Where a label is affixed on the container...
Read More
south korea
25Jul 2024
Registrations, General Information admin Comments: 0

Why South Korea is a Booming Market for Medical Devices? 

South Korea has emerged as a significant player in the global medical device market, and its growth trajectory is impressive. The convergence of government support, advanced technology, a strong domestic market, and strategic trade positions South Korea as a hub for medical device innovation and investment.  Here’s an in-depth exploration of the factors contributing to this booming market.  1.Government Support and Strategic Policies  1.1. Regulatory Framework and Incentives&nbs...
Read More
12Jul 2024
General Information Cubicdesignz Comments: 0

Product Liability Insurance for Medical devices

Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction for use of a product. These defects can cause risks to patients, who in turn can sue the manufacturer for the damages caused. As medical device manufacturers, it is imperative to choose insurance that best covers themselves as well as their affiliates. Product liability was brought in place to ensure that potentially unsafe products are discouraged from being plac...
Read More
12Jul 2024
General Information Cubicdesignz Comments: 0

Establish a Medical Device Startup Company

Introduction: Medical device startups play an essential role in revolutionizing patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started. Tips to start a Medical Device Startup Company 1. Brainstorm an Engaging Idea: Every successful medical device startup begins with an original idea. Start by researching the healthcare in...
Read More
General Information, EU July 12, 2024 Cubicdesignz Comments: 0

MDCG Position Paper on the Implementation of UDI Requirements for Contact Lenses, Spectacle Frames, Spectacle Lenses & Ready Readers 

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.   The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only...
Read More
12Jul 2024
General Information Cubicdesignz Comments: 0

Definition of a Medical Device around the global market

What is a Medical Device? The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly. An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries....
Read More
12Jul 2024
General Information Cubicdesignz Comments: 0

Navigating Healthcare with Implant ID Cards: What You Need to Know?

Implant ID Cards Introduction Implanted medical devices, from life-saving pacemakers to pain-relieving joint replacements, are transforming how we manage health conditions. However, carrying these technological marvels within our bodies presents a unique challenge: readily accessing critical information about them when seeking medical care. This is where the power of implant ID cards comes into play. Think of these cards as miniature medical passports, discreetly holding a wealth of knowledge ab...
Read More
12Jul 2024
General Information Cubicdesignz Comments: 0

OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

Book time with Gayathri Ganesan: KIMES Exhibition   OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 1...
Read More
12Jul 2024
General Information Cubicdesignz Comments: 0

Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry

In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized globally under different titles, including Responsible Person (RP), Agent for Service of Process, Local Agent, Legal Representative (LR), and Designated Contact Point (DCP), Market Authorization Holder (MAH). Their role carries sig...
Read More
bola gacor https://ecomama.com.vn/storage/pages/ways/ https://portia-bazar.com/import/ https://chatgptitaliano.com/ https://www.studio98.com/ https://acunmedyaakademi.com/ https://trailer.best/ https://klicfon.com/ iblbet iblbet https://www.studio98.com/ https://iniciarbr.com/ https://bntva.ru/css