Medical Device Registration and Certificate

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Medical Device Registration and Certificate

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP is a trusted leader in medical devices consulting, providing expert guidance to navigate market-specific requirements and ensure compliance with local and global regulations, facilitating safe export and distribution.

Medical Device Registration Compliance: Essential Insights for Your Business

Medical device registration, often required by local and international regulatory authorities, is crucial for ensuring patient safety and maintaining compliance. This process establishes a framework for verifying device safety, effectiveness, and regulatory adherence, enabling healthcare providers and patients to make informed decisions.

For markets requiring registration, compliance is essential to avoid complications during importation and distribution, reducing the risk of delays, fines, recalls, or market restrictions due to non-compliance.

Most countries, including the United States, Europe, South Korea, China, and ASEAN members, require registration. KGMP provides comparative insights into these regulatory requirements, helping you navigate your target market's standards.

KGMP Medical Device Registration Service

Classification & Device code	Device approval by authorities	Establishment registration	Medical device notification

Key Stage of Medical Device Registration

We provide comprehensive medical device facility registrations, product listings, and technical document such as STED, 510(k) documents, MDR/IVDR documents in compliance with the regulations of your target market, along with a range of additional services. Our support includes reviewing necessary documentation, managing required laboratory testing, assisting with Responsible Person (or U.S. Agent) requirements, and providing timely updates throughout the registration process.

Our support includes classification and device code analysis, reviewing required documentation, managing necessary laboratory testing, assisting with Responsible Person (or U.S. Agent) requirements, and providing timely updates throughout the registration process.

 

Medical Device Registration Service

While the product registration procedures for each country can be found below, our services are not limited to these processes.

ㆍ      Unite States: U.S. FDA & 510(k) Notification

ㆍ      EU & UK: CE/UKCA Marking & MDR/IVDR Compliance

ㆍ      South Korea: MFDS compliance

ㆍ      Others: We offer customized solutions tailored to your target market's specific needs. (e.g. China, ASEAN, South America)

 

Certificate of Medical Device Registration (or Notification) Service

To strengthen the assurance that your products are successfully registered in the target market, we issue an exclusive KGMP certificate.

Remember that different regulations apply in each country.

Contact us today to discover how our medical device label compliance and UDI services can benefit your business.

KGMP simplifies compliance with complex cosmetic regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.     

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

Global expertise	Quality audit	Scientific expertise	Training	1:1 Consulting

Our professional, dynamic, and pragmatic team is ready to assist you with information and training.

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