Medical Device GMP(Good Manufacturing Practice)

🔵 Electrical Safety Test

🔹GMP

It is a quality management system specialized for the medical device industry designed to ensure, to a high degree, that medical devices produced by manufacturers are consistently manufactured with quality that is safe, effective, and suitable for their intended use.

🔹 By Major Countries GMP

  • International Standards:: ISO 13485
  • KOREA: KGMP(ISO 13485 based)
  • EUROPE: EN ISO 13485
  • USA: As the existing QSR (21 CFR 820) has been reorganized into QMSR, direct reference to ISO 13485:2016
  • JAPAN: JGMP(ISO 13485 based)

🔹 Applicable to

  • Medical device manufacturer
  • Medical device importer
  • Manufacturer of medical devices for clinical trials

🔹 Screening classification

  1. Initial screening
    • The initial review received to recognize that a manufactured or imported medical device conforms to GMP standards.
    • Verification of GMP system establishment and facility equipment procurement
  2. Additional review
    • Examination required when intending to manufacture or import medical devices from other product groups in addition, pursuant to Annex 3 of the GMP Notification
    • Equipping facilities and equipment for the relevant product group, appropriate modifications to the GMP system, etc.
  3. Change review
    • Inspection required when the manufacturer’s location changes (relocates). However, changes to storage areas or testing laboratories that are not significantly related to product quality are excluded.
    • Installation of facilities and equipment due to relocation, appropriate changes to the GMP system, etc.
  4. Regular review
    • Periodic inspection of GMP application performance required once every three years in accordance with the Enforcement Rule of the Medical Devices Act and the GMP Notification
    • Application submitted 90 days prior to the expiration of the Certificate of Conformity

🔹 Reviewing Authority and Scope

🔹 Evaluation method criteria

🔹 Scope of review

  • Review of medical device manufacturing facilities by product group
  • Audit of all activities and quality management systems related to medical device manufacturing
  • In the case where a manufacturing facility manufactures by entrusting and receiving manufacturing processes (hereinafter referred to as the “Client-Manufacturer”), both the Client-Manufacturer are subject to review.

🔹 Review process

  1. Application
  2. Receipt
  3. Preliminary Review
  4. Request for supplementation
  5. Preliminary Screening
  6. Main Review
  7. Final Approval

🔹 GMP Requirements

  • Quality Management Manual
    • Includes documented descriptions of the quality policy and quality objectives, and defines the basic policy regarding the quality management system in accordance with the Medical Device Manufacturing and Quality Control Standards.

  • Quality Procedures
    • Establishment of a document that corresponds to the documented procedures and record forms required by the Medical Device Manufacturing and Quality Control Standards, and describes, maintains, and manages the procedures and methods for performing the responsibilities of each department mentioned in the Quality Management Manual.

  • Records, work instructions, and other Documents
    • Work Guidelines
      • Establishing a document that supplements quality procedures to describe, maintain, and manage the procedures and methods for performing the responsibilities of each department.
    • Technical Documents
      • Establishment of documents derived from product development and design, used for licensing purposes, in which details regarding product-related design drawings, manufacturing methods, product configuration diagrams, intermediate assembly drawings, and product usage are attached or referenced.
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