KGMP for Medical Device Importer

Establishing a Quality Management System for Medical Device Importers

Medical devices directly impact human life and health. Therefore, the Ministry of Food and Drug Safety (MFDS) legally requires manufacturers and importers to establish a quality management system to ensure the production and importation of safe and effective medical devices that achieve their intended performance.

Our company offers the following services to assist importers in establishing a quality management system that complies with the relevant regulations:

  • 1) Conduct on-site training by technical experts on building a QMS for importers.
  • 2) Provide guidelines, procedures, and record templates necessary for importers to establish a quality management system.
  • 3) Guide the development of a quality management system process tailored to the characteristics of the company and imported devices.

 

Quality Management System (QMS)

A quality management system is a set of procedures established to ensure consistent quality from product design and development through manufacturing, inspection, storage, sales, installation, and service. It also includes activities such as complaint handling, corrective actions, communication with regulatory authorities, and product recalls to ensure continuous product improvement even after market release.

 

Necessity of Establishing a Quality Management System for Importers

Requirements for a quality management system are not limited to medical device manufacturers. Importers of medical devices are also required to establish and operate a QMS in accordance with relevant procedures, as specified in the following regulations:

  • 1) Article 13, Paragraph 1 of the Medical Device Act (Obligation of Importers to Maintain a Quality Management System)
    • Importers must maintain facilities and a quality management system as required for import licensing and comply with additional requirements, such as self-testing, for imported products as prescribed by Presidential Decree.
  • 2) Article 33 of the Medical Device Act Enforcement Regulations (Presidential Decree No. 1841)
      • Article 33 outlines the compliance requirements for importers and specifies the procedures and record templates necessary for quality management of medical devices. Importers must manage and document these in accordance with an established QMS.
  • 3) Annex 4 of the Medical Device Act Enforcement Regulations (Standards for Facilities and Quality Management Systems for Importers)
      • According to Item B of Annex 4, importers must document and implement detailed procedures and methods for their QMS. They are subject to a regular inspection every three years to verify compliance.

 

Administrative Penalties for Non-compliance with the Quality Management System

Failure to comply may result in administrative penalties as outlined in Annex 8 of the Medical Device Act Enforcement Regulations. Examples include:

  • Failure to create and maintain documents related to storage, inbound/outbound, and quality control of imported medical devices and accessories, or failure to create and maintain product specifications and import management guidelines per Article 33, Paragraph 1, Items 2, 7, and 8.

    • Penalties include:

  • 1st violation: Suspension of all import activities or suspension of the import of the relevant item for three months.
  • 2nd violation: Suspension of all import activities or suspension of the import of the relevant item for six months.
  • 3rd violation: Revocation of import license or prohibition of import.

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    Please CONTACT US for any inquiry regarding MDR.