Revision of Korea's Medical Device GMP Operating Guidance.

The operating guidance for Korea's medical device manufacturing and quality management standards (GMP) has been revised.

The guidance aims to ensure accurate, consistent and transparent implementation of the medical device GMP standards by the personnel responsible.

Particular attention should be paid to the newly added device specification document requirements for representative products.

Manufacturers must maintain a device specification document for the representative model or product to satisfy Annex 2, clause 4.2.3.

Contact BCG if you need help preparing device specification documents or addressing requests for further information or non-conformities under the revised guidance.

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