MFDS Publishes English Materials on Medical Device GMP Regulations

News and Regulatory Updates

Date: 11 February 2026

The MFDS English regulatory page has published Medical Device GMP Regulations materials, reminding companies exporting to Korea to continue to focus on quality system, manufacturing control and on-site compliance requirements.

Source

Source institution: MFDS

Original date: 11 February 2026

Publication time on this site: 8 July 2026, 09:00

Original link: https://www.mfds.go.kr/eng/brd/m_40/view.do?company_cd=&company_nm=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&page=1&seq=72638&srchFr=&srchTo=&srchTp=&srchWord=

This article is based on the official MFDS public page.

Full Translation of Core Content

The MFDS English regulatory page shows that the Medical Device GMP Regulations materials were published on 11 February 2026. Medical device GMP is an important foundation for market access and ongoing supervision in Korea, covering the quality management system, manufacturing process, supplier management, record control, corrective and preventive actions, product release and continued compliance.

For companies entering the Korean market, product registration dossier and quality management system evidence must be consistent with each other. If the manufacturing address, critical processes, outsourced processes, suppliers, model specifications, quality records and change information are inconsistent with the registration dossier, this may lead to deficiency letters, review delays or subsequent compliance risks.

Even if a company already holds an ISO 13485 certificate, it still needs to conduct a gap assessment against Korean GMP requirements. Korean projects should not focus only on product document submission; they should also prepare evidence for the quality management system, production control and post-market feedback handling in parallel.

Impact on Companies

Medical device companies entering the Korean market should not focus only on product registration documents; they should also confirm whether the manufacturer's quality management system evidence meets Korean requirements. If a company already has ISO 13485 or another quality system certificate, it still needs to assess gaps against Korean GMP requirements, in particular the actual manufacturing address, critical processes, outsourcing controls, change records and post-market feedback handling.

AIMEILI Regulatory Interpretation

AIMEILI Regulatory Department considers that updates related to GMP, supplier control and data integrity point to regulators' continued focus on the “credibility of evidence.” Medical device registration is not simply a matter of submitting test reports, quality management system certificates and technical documents; regulators will increasingly examine the manufacturing process, outsourcing controls, supply chain changes, raw data and record consistency behind these materials.

For companies, third-party testing, sterilization, software outsourcing, key components, clinical data, performance verification and quality management system records all need to be traceable. If supplier changes have not been assessed, test data lack raw records, or the manufacturing address, model specifications, process flow and quality management system scope in the registration dossier are inconsistent, problems may be exposed during review, quality system inspections or post-market investigations, even if individual documents appear complete.

AIMEILI recommends that companies conduct a “document credibility review” before overseas registration: verify the consistency of certificates, test reports, raw records, supplier agreements, change records, quality agreements and technical documents. For companies preparing to enter markets such as Korea, the United States, the European Union and Canada, quality management system evidence should be developed in parallel with the registration dossier, rather than being explained on an ad hoc basis after a regulator raises questions.

Business Impact and Compliance Actions

These developments affect regulatory strategy, dossier preparation, supplier management and post-market compliance for manufacturers, distributors, CROs and regulatory affairs teams. Companies should confirm whether the update affects existing registration pathways, certificate maintenance or post-market obligations; verify the technical file, labels and instructions for use, quality management system and local responsible entity arrangements in the target country; establish change impact assessments and regulatory update tracking records for marketed products; and, where necessary, archive the official original text, translated interpretation and internal action items for subsequent audits and project reviews.

Related Regulatory Updates

• 26 February 2026: IMDRF published a practical handbook on medical device regulatory reliance projects.
• 7 July 2026: FDA announced a public meeting on medical device user fee reauthorization.
• 6 July 2026: PMDA updated the English page for Software as a Medical Device (SaMD).
• 6 July 2026: FDA published recall information for the Abiomed Impella CP with SmartAssist heart pump.
• 6 July 2026: FDA published recall information for the Hologic BioZorb 3D bioabsorbable implant marker.
• 6 July 2026: FDA published recall information for Insulet Omnipod Pods insulin pumps.
• 6 July 2026: FDA published correction information for the North American Rescue first aid kit TRUE METRIX device.

Content Review and Applicability

Content author: AIMEILI Regulatory Editorial Department

Professional review: AIMEILI Medical Device International Registration Project Team

Source principle: Priority is given to official regulatory authorities, international organizations, standards organizations and public regulatory materials; industry media and project experience are used only as supporting judgment.

Applicability: This article is intended for preliminary understanding, document preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal opinions.