(1) Reasons for Proposal

To reflect amendments to the international standard for medical devices (ISO 13485), the Amendment aligns “GMP Compliance Recognition and Other Assessment Criteria for Medical Devices” with international standards; adds documents required to be submitted for assessments involving only a ducment review and streamlines document review criteria, thereby addressing blind spots in quality control; modifies definitions of terms; and improves the issuance and management of GMP certificates, thereby aiming to improve GMP operation.

(2) Major Provisions

A. Harmonize “GMP Compliance Recognition and Other Assessment Criteria for Medical Devices” with international standards (Article 5, attached Table 2, and attached Table 2-2)

Align assessment criteria with international standards by reflecting amendments to international quality control standards (ISO 13485:2016) and newly inserting “[Attached Table 2] GMP Compliance Recognition and Other Assessment Criteria for Medical Devices”, changing the former “[Attached Table 2]” to “[Attached Table 2-2],” and applying these changes to the assessment criteria

B. Improve document review criteria (Article 6, paragraph 2; Article 7, paragraph 2; Article 7, paragraph 6)

Improve provisions to state that even where a legal manufacturer has two or more manufacturers, a manufacturer subject to an initial assessment shall undergo an on-site inspection

C. Clarify the definition of “manufacturing site of risk concern” (Article 6, paragraph 3; attached Table 1-5)

Improve the judgment criteria for manufacturing sites of risk concern by clarifying the definition of “manufacturing site of risk concern”

D. Improve provisions concerning the information examined in document reviews (Article 7)

Enhance the standards of document reviews by prescribing that an assessment involving only a document review shall require the submission of six additional types of information, namely an organizational chart, outline of quality document management, checklist based on [Attached Table 2] or [Attached Table 2-2], compliance declaration, validation data for production and service provision processes, and summary of the management of monitoring and measuring equipment

E. Improve the assessment procedure (Article 8)

Specify the administrative procedure applicable to cases where documents for an assessment application require supplementation by reflecting the Administrative Procedures Act; prescribe procedures for suspending an assessment due to such factors as force majeure during an on-site inspection period or refusal to provide assessment materials, and procedures for resuming the assessment thereafter; and improve the administrative handling procedures for sole assessments of Class 2 medical devices conducted by an assessment agency

F. Modify definitions of terms (attached Table 1)

Delete unused terms; modify terms that are redundant or have unclear meanings; and add new terms resulting from the new insertion of [Attached Table 2-2]

G. Improve the assessment application form and results report form (attached Table 2, attached Form 1)

Improve forms by requesting detailed information on manufacturers and process flow charts, etc., in the assessment application form, and indicating [Attached Table 2] or [Attached Table 2-2] in the results report form

H. Improve the issuance and management of GMP certificates (attached Table 5)

Improve provisions on the issuance of GMP certificates for Class 1 medical devices and medical devices for export, and the method used to assign control numbers to re-issued GMP certificates