Medical Device Service

Zoe Medical provides the most efficient and responsive regulatory and quality services across the full spectrum of medical device development including every step toward successful market entrance and post-market activities.

Based in Korea, Zoe Medical has been successful in delivering the best quality service for the companies entering the Korean market.  It even expands its full service to the Japanese market with multiple partners to secure the most efficient solution.  With regulatory expertise in Korea and Japan, we bring accuracy and efficiency to your business process.

There are specific regulatory requirements in Korea and Japan, and understanding the rules and pathways is the beginning of your successful move.

 

SCOPE OF SERVICE

From Regulatory Pathway and Gap Assessment Report to License Holding and Distribution, we provide total service.  In Korea, we often call this ONE-STOP service, meaning that clients do not have to ask here and there to get the best, ideal answer. Clients want the excellent final result, and we strive to provide the best solution for clients.

  • REGULATORY PATHWAY AND GAP ASSESSMENT REPORT

With our medical device and IVD (in-vitro diagnostics) consulting approach, you maintain the full control on the entire project.  Our detailed support will save significant time and efforts with our insightful and very practical strategies.

  • KOREA (MFDS) / JAPAN (MHLW) REGISTRATION

We also prepare submissions, plan testing, manage communications with regulatory bodies, and provide all the additional activities required for registration and maintaining of medical device and in-vitro diagnostics (IVD).  With our medical device and IVD registration support, you will achieve the most effective and successful registration.  Thorough preparation does save time and cost.

  • LICENSE HOLDING SERVICE

We represent the client and are responsible for the product liability to the regulatory bodies in Korea and Japan, including quality system management and advertisement on behalf of manufacturer.

Our practical services include, but are not limited to:

(1) Adverse event reporting to MFDS (Korea) and MHLW (Japan)

(2) Import, customs clearance and product release

(3) Quality system management for GMP requirements

(4) Active Communications with the customers to be compliant with local regulations

  • POST-MARKET SUPPORTS

We provide the full post-market support services such as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed.  The details can be discussed depending on the type of the product.

 

EFFICIENCY

Efficiency is our best expertise.

1.  We understand that the approach could be significantly different depending on the products. We will provide the best solution within the agreed timeline with a client.

2.  We will come up with a specific solution.

3.  We will connect the client to the vendor of our best knowledge if we decide that another team of experts can better handle the products.

Please contact us at info@asia-register.com with your inquiries and brief explanation of your product.

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Regulatory Pathway Strategies

Before commercializing a device in Korea and Japan, it is important to determine the proper classification and applicable regulatory requirements to which the device must adhere.

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Key Requirements

Product Code and Regulation Number Determination / Classification Determination / Identification of Applicable Standards and Guidance Documents / Confirmation or Identification of Potential Predicate Devices / List of Applicable Tests / Premarket Pathway Strategy / Quality System Requirements