엠디웍스코리아

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Quality Management

Import Quality Management

Background and legal basis

Background

With the Good Importing Practice (GIP) system abolished on April 8, 2012, and replaced by GMP (Good Manufacturing Practice) audits of foreign manufacturers, importers must maintain import quality management in accordance with importer obligations under the Medical Devices Act.

Legal basis

• Medical Devices Act

Medical Devices Act Enforcement Rules, Article 33

Essential import quality management documents

Documents required for import quality management

Standards, procedures, and record forms needed to manage imported product quality in a consistent manner are prepared in a structured way.

Master documents

Import management standard

Procedure documents

Work instructions, product specifications

Records

Record forms

Import quality management document structure

Documents may be organized in the following system.

Quality document Document name Form name
Import management standard N/A
Work instructions Document control procedure Log of externally sourced documents
Product control procedure List of foreign manufacturing sites
Facility control procedure Office and warehouse inspection checklist
Sterilization control procedure Sterilization control log
Testing and inspection procedure Receiving/shipping inspection reports
Nonconforming product control and corrective action procedure Nonconforming product report
Nonconforming product identification labels
Receiving, storage, and shipping procedure Receiving/shipping/disposal records
Medical device import performance report
Training procedure Training plan
Training completion report
Safety information management procedure Adverse event and safety information report
Product specifications N/A