Focused on Quality, Driven by Results
MISSION-DRIVEN
1
BCG supports all procedures necessary to meet regulatory requirements and successfully obtain manufacturing and import licenses for medical devices. For manufacturing licenses, we assist with facility requirements and the establishment of a Quality Management System (QMS). For import licenses, we help with reviewing import procedures and regulatory requirements, including document preparation and audit responses. We manage all steps systematically to ensure clients can operate their business smoothly in the domestic market.
2
BCG reviews your manufacturing processes and quality systems according to medical device manufacturing and quality management standards (GMP), offering customized solutions for obtaining certification. We assist manufacturers in meeting domestic and international regulatory requirements by providing support in document preparation, equipment validation, process validation, and more. BCG ensures thorough preparation for GMP audits to help clients meet all required standards. This way, we support our clients in consistently producing high-quality products.
3
We provide systematic support for the approval process of medical devices and in-vitro diagnostic devices, ranging from Class 1 to Class 4. BCG professionally manages the processes of preparing and submitting technical documentation, responding to reviews, and more, offering customized strategies to meet the regulatory requirements for each class. This ensures that your products can compete not only in the domestic market but also in the global market.
4
We support the regular product renewal process to ensure continuous regulatory compliance for already approved medical devices. This includes preparing required documents, reviewing regulatory requirements, submitting materials, and responding to reviews. BCG professionally manages all steps to ensure that your products remain in the market, aligned with the latest regulations and market changes. This helps clients avoid business interruptions due to product license expiration.
5
We provide market analysis, economic evaluation, reimbursement application preparation, and audit responses for the inclusion of medical supplies in health insurance coverage. BCG prepares data to demonstrate the efficacy and cost-effectiveness of medical supplies, supplements the documentation to meet regulatory requirements, and supports re-evaluations and compliance after listing. This helps our clients secure a competitive edge in the market and improve accessibility for healthcare institutions and patients.
6
We provide local authorized representative services to help foreign medical device manufacturers enter the domestic market. BCG acts as a liaison with regulatory authorities, serving as the legal representative to ensure compliance with domestic regulatory requirements. We handle all stages of the process, including the approval procedure, product registration, post-market surveillance, and collaboration with regulatory agencies, helping clients minimize legal risks and operate their business smoothly.
7
We provide specialized translation and interpretation services for regulatory compliance related to medical devices and pharmaceuticals. BCG specializes in translating regulatory documents such as GMP and GLP, as well as interpretation at international meetings, removing language barriers to help clients smoothly manage global business and regulatory responses. This helps resolve communication issues that may arise in international collaboration and market expansion, supporting the successful progress of projects.