1. Purpose of the Medical Device GMP System
The Medical Device GMP system is a minimum requirement that ensures the consistent manufacturing and sale of products of safe, effective, and suitable quality for their intended use by securing a quality management system for the entire process, including the design, development, production, and post-market management of medical devices.
Medical devices are products that directly or indirectly affect human life or health, and due to their nature, a high level of quality control is required. Therefore, the following matters must be considered comprehensively.
– Minimize errors, confusion, and other mistakes caused by workers or managers
– Prevention of medical device contamination by bacteria or foreign substances
– Prevention of the use of unverified raw materials and minimization of quality variations caused by process variables
– Maintaining a system capable of guaranteeing quality above a certain level
2. Scope of Application
This Article sets forth detailed matters regarding manufacturing and quality control that must be observed in the manufacture of medical devices, GMP audit procedures and methods, designation procedures for quality control audit bodies and quality manager training institutions, and detailed compliance requirements, and specifically defines the subjects to which it applies.
However, since the reviewing body and method for medical device GMP conformity assessment vary depending on the manufacturing facility, product group, and product grade, you must verify the relevant medical device product group classification and grade before applying for GMP conformity assessment.
1) Persons who obtain a medical device manufacturing or import permit or certification, or who file a manufacturing or import declaration
2) Persons who intend to manufacture or import medical devices for clinical trials
3) Medical device manufacturers or importers who wish to undergo a conformity recognition review
4) Persons who have been designated as or intend to be designated as a quality control auditing body
5) Persons who have been designated or intend to be designated as a quality manager training institution
3. GMP Audit Classification
GMP audits are classified into four types of audits, and applications for GMP audits can be made according to these classifications.
1) Initial screening
– If the manufacturer of the medical device in question has never received recognition of conformity under these standards, or even if they have received such recognition but the information of the commissioner or manufacturer changes due to changes in the manufacturing process outsourcing contract, it is classified as an initial review.
2) Additional review
– GMP inspections are conducted for each product group of the relevant manufacturing facility, and are classified into 64 product groups in accordance with the aforementioned notification.
– If a manufacturing facility accredited for GMP conformity manufactures additional medical devices belonging to a new product group, it must undergo an additional review for that product group.
3) Change Review
– If a manufacturing facility that has received GMP conformity certification changes its location (relocation, expansion, reduction, etc.), it must undergo an additional GMP audit regarding the items specified in Article 5, Paragraph 2, Subparagraph 2 of these Standards. However, changes (relocation, expansion, reduction, etc.) to storage areas and testing laboratories that are less related to product quality are excluded.
– Manufacturing facilities possessing software product groups are excluded from change review when changing their location (relocation, expansion, reduction, etc.), taking into account manufacturing facilities and product characteristics; subsequently, regular review shall verify the adequacy of quality control resulting from the location change.
4) Regular review
– In accordance with [Table 2] Subparagraph 2 (e) and [Table 4] Subparagraph 3 (b) of the Enforcement Rules of the Medical Devices Act, medical device manufacturers or importers are required to undergo periodic inspections every three years as notified by the Minister of Food and Drug Safety regarding compliance with GMP standards. Medical devices for export, Class 1 medical devices, medical devices for clinical trials, and pharmaceuticals or quasi-pharmaceuticals combined with or composed of convergence medical devices are not subject to periodic inspection.
4. Audit Criteria
1) GMP Conformity Certification for Medical Devices for Clinical Trials
– In the case of medical devices for clinical trials, considering that the product is in the development stage and the manufacturing process is not yet fully established, the evaluation of items from item 4 (Quality Management System) to item 5 (Management Responsibility) and item 6 (Resource Management) of the evaluation criteria is excluded, and only items related to the manufacturing and quality control of the product are applied for evaluation.
– However, after obtaining GMP conformity certification for medical devices for clinical trials, if the purpose is for sale or mass production rather than clinical purposes, a new GMP audit (initial audit) must be conducted by applying all evaluation items.
2) GMP compliance recognition due to change of location
– In the event of a change in the manufacturing facility of a medical device, since changes in manufacturing facilities and the working environment may affect product quality, the review is conducted by applying only items related to overall document management, environmental management, and production management.
– Change audits apply only when the manufacturing facility producing the product changes (relocation, expansion, reduction, etc.) on the condition that the same quality management system is maintained.
3) Class 1 Medical Device GMP Conformity Certification
– Class 1 medical devices, which pose virtually no risk to the human body, are not subject to mandatory GMP inspection; however, they must comply with GMP standards in accordance with the compliance requirements for medical device manufacturers (importers) under the Medical Devices Act. Nevertheless, if one wishes to undergo an inspection for GMP conformity recognition, etc. for Class 1 medical devices, the inspection may be conducted with the exclusion of certain evaluation items.
5. Audit method
In principle, medical device GMP audits are conducted through on-site inspections and document reviews for each product group at the manufacturing facility, and the quality management system and all activities related to medical device manufacturing are subject to GMP audit.
– Even in cases where manufacturing processes are outsourced or contracted, document reviews and on-site inspections are conducted for both the client and the manufacturer; furthermore, if the client outsources major processes* to the manufacturer, it is considered a full process outsourcing, and a GMP audit is conducted.
– If the review team determines during the review process that additional on-site inspection is necessary, such as due to the sub-outsourcing of major processes, the relevant manufacturing facility may be included in the review. However, the review entity and method may vary depending on the grade of the items manufactured at the facility and the type of review.
6. Audit process
1) Check the status of materials submitted for GMP review
– When applying for a GMP inspection, the submission of attached materials pursuant to Article 7, Paragraphs 1 through 7 of this Notice is verified within 5 days. Please be aware that if the verification of the submission of attached materials reveals deficiencies such as incompleteness, the application may be rejected or required to be supplemented.
* If submitted materials are incomplete, a supplementary period (5 days) is granted → Application rejected if not submitted within the period *
2) GMP Audit Receipt and Reporting
– Quality control audit agencies that receive GMP audit applications report to and request confirmation from the regional Food and Drug Administration within 7 days regarding the receipt of the application and whether the facility is subject to hazardous manufacturing, etc. Medical device manufacturers and importers need to verify in advance whether the facility is subject to hazardous manufacturing, etc., indicate this in the application, and prepare relevant materials.
7. Audit processing period
- Document Review: Within 30 days from the date of receipt of application
- Field Survey: Within 7 days from the completion date of the field survey
* The period from the date of receipt to the start of the on-site investigation is not included in the processing period *
8. Expiration period
1) In the case of initial/additional/change review
– If the GMP audit results are satisfactory, the quality control audit agency issues a “Certificate of Conformity to Medical Device Manufacturing and Quality Management Standards” in accordance with Form No. 2 attached hereto, and the validity period is stipulated to be 3 years from the date of issuance.
– Since the recognition of medical device GMP conformity is conducted for each product group based on the manufacturing and quality control systems of the facility, Article 5 of these standards stipulates that only some evaluation items shall be applied when a facility that received recognition of conformity in the initial review applies for a GMP review due to the addition of product groups or a change of location.
– Therefore, since additional and modification audits are applied to manufacturing and quality control systems that have already been recognized for GMP conformity, they do not affect the validity period of the existing certificate of conformity.
2) In the case of regular inspections
– If a periodic inspection certificate of conformity is issued before the expiration of the validity period of the existing certificate of conformity, the validity period is granted for three years from the day following the expiration date of the existing certificate of conformity.
– If a periodic inspection certificate of conformity is issued after the expiration of the validity period of an existing certificate of conformity, the validity period is granted for three years from the date of issuance of the new certificate of conformity.
– In the case of a bulk application for regular inspection, a document review is conducted for the remaining manufacturing facilities excluding those subject to on-site inspection, and each certificate of conformity is granted for three years from the date of issuance.
3) In cases where another manufacturer or importer holds a Certificate of Conformity for the relevant manufacturing facility
– It is granted for the same validity period as stated on the Certificate of Conformity held by other manufacturers or importers.
4) In cases where a Certificate of Conformity for In Vitro Diagnostic Medical Devices is held pursuant to the In Vitro Diagnostic Medical Devices Act
– It is granted for the same validity period as the existing Certificate of Conformity of manufacturers and importers of in vitro diagnostic medical devices.