Medical Device Manufacturing and Import License Consulting

MISSION-DRIVEN

Manufacturing and Import License

Manufacturing and import licenses are essential procedures that grant the legal authority to officially manufacture or import medical devices. These licenses serve as the foundation to ensure that companies comply with domestic regulatory requirements and can provide safe and reliable products to the market.

Through obtaining licenses, companies can secure credibility and establish themselves as trusted business partners by regulatory authorities and consumers. Additionally, without the necessary licenses, product manufacturing and distribution are not possible, which can lead to business interruptions and legal issues, making it a requirement that must be met.

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Manufacturing License

BCG supports medical device manufacturers in meeting domestic regulatory requirements to successfully obtain a manufacturing license. To achieve this, we thoroughly prepare according to the Medical Device Act, Medical Device Enforcement Rule, Appendix 2 (Standards for Manufacturing and Quality Management Systems), which includes preparing manufacturing facilities, establishing a Quality Management System (QMS), and setting up operational procedures.
We inspect the manufacturing environment and facilities to ensure compliance with regulatory requirements and provide systematic support for all steps, including document preparation, submission, and audit responses required for the manufacturing license application.

Import License

BCG provides consulting services to ensure that medical device importers comply with Article 33 (Importer’s Compliance Requirements) of the Medical Device Act and its Enforcement Rules. Importers must have an appropriate quality management system in place to supply safe and reliable medical devices to the domestic market, and we support all the necessary procedures for this.
BCG manages the entire process, from document preparation, submission, and import registration audit responses, to reviewing the requirements that importers must meet and helping resolve regulatory agency requirements.

PATH TO SUCCCESS

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