SPECIFY · Certification support
Connect SaMD requirements, design, risk management, verification and traceability records. Distinguish Korean MFDS requirements from international standards.
Clarify whether the product is medical device software, its functions and clinical purpose, and where it will be supplied. Korean MFDS authorization, GMP and international development standards address different parts of the preparation.
Prepare requirements, architecture and detailed design, risk controls, verification and validation records, configuration management and traceability. Make sure the product version and evidence agree.
Review medical software, medical GMP, IEC 62304, ISO 14971 and ISO 13485 as applicable. A standard is not automatically a product authorization; the applicable authority determines the required submission.
Korean certification schemes and international standards are different. A translated guide does not extend a Korean certificate to other countries. Confirm the target market, product classification and current requirements with the relevant body.
Medical & healthcare
Plan Korean SaMD and digital medical device approval: intended use, classification, software verification, clinical and safety evidence, GMP and optional regulatory consulting.
Documents to prepare →Medical & healthcare
Prepare for Medical Device GMP and Digital Medical Device GMP. Review applicability, required evidence, assessment steps, institutional fees and optional expert support.
Documents to prepare →Medical & healthcare
Prepare for ISO 13485. Review applicability, required evidence, assessment steps, institutional fees and optional expert support.
Documents to prepare →Medical & healthcare
Prepare IEC 62304 medical software lifecycle evidence: development plans, safety classification, requirements and test traceability, configuration and maintenance records. Review assessment and consulting scope.
Documents to prepare →Medical & healthcare
Prepare for ISO 14971. Review applicability, required evidence, assessment steps, institutional fees and optional expert support.
Documents to prepare →Medical & healthcare
Prepare for IEC 62366-1. Review applicability, required evidence, assessment steps, institutional fees and optional expert support.
Documents to prepare →Medical & healthcare
Prepare for Digital Therapeutics (DTx) Regulatory Approval. Review applicability, required evidence, assessment steps, institutional fees and optional expert support.
Documents to prepare →Medical & healthcare
Prepare for Electronic Medical Record System Certification. Review applicability, required evidence, assessment steps, institutional fees and optional expert support.
Documents to prepare →Document automation and management cost KRW 300,000 per month. Expert services and certification body testing or assessment fees are separate. Specify supports preparation; the relevant authority or certification body makes the final decision.