Technical Document Structure and Its Correspondence with IMDRF STED

1. Key takeaways

The Technical Document is a statutory concept in Korea, not a checklist improvised by the reviewing authority. Article 2, Paragraph 2 of the Medical Device Act defines the Technical Document as quality documentation concerning performance and safety, comprising 7 statutory elements: raw materials, item structure, intended use, instructions for use, principle of operation, precautions for use, and testing specifications. These 7 elements correspond closely to the modular structure of IMDRF STED, so manufacturers that already hold EU MDR technical documentation or compile dossiers in STED structure can map and reuse instead of rewriting from zero.

• Reuse does not mean direct submission. Three localization actions are fixed in GRZAN Korea projects: testing specifications must connect to the Korean item standard specifications, with self-set specifications and stated justification where none covers the item (practical estimate); instructions for use must be synchronized with the container, outer packaging and leaflet labeling layers; and the Korean translation must be countersigned by the quality manager of the licence holder.
• Item notification for Class 1 devices is exempt from the Technical Document, but what is exempted is the act of submission, not the authoring of this documentation.

2. Legal basis

The following instruments define the Technical Document, its review and its relationship with quality system requirements. Regulatory information verified as of October 29, 2026.

Mapping of the 7 statutory elements to IMDRF STED modules. The mapping below was compiled by GRZAN on the basis of IMDRF STED modules for documentation reuse; it is not a Korean statutory list (practical estimate).

3. Expert insights

The statutory anchor of the Technical Document is quality documentation; reviewers ask for evidence, not page counts. Article 2, Paragraph 2 lands the definition on quality documentation concerning performance and safety, so review questions point one way: on what evidence. The structural problem GRZAN encounters most frequently is dossiers ordered in the sequence of Chinese registration submissions and opening with a product overview, while the raw material list and testing specifications a Korean reviewer needs sit in appendices. Misplaced order leads to a deficiency request rather than outright failure, but every deficiency round resets the rhythm (the specific effect on the review period is as stated in the deficiency notice of the accepting authority).

The 7 elements map closely to STED, but 3 positions shift reliably. The first is the mixing of principle of operation with mechanism of action (MoA): the Technical Document asks how the device acts on the human body, while the substantial equivalence comparison asks for consistency of mechanism with the comparison device; the two address different objects. The second is testing specifications: items with Korean standard specifications must map directly, and items not covered must be self-set with stated justification (practical estimate). The third is instructions for use: the instructions in the Technical Document must be consistent with the three layers of container, outer packaging and leaflet labeling, and a change in any one layer propagates to the other two.

Class 1 is exempt from submission, but the Technical Document content must still live in the quality system. For Class 1 items the exemption removes the act of submitting to the reviewing authority; the notification process is covered in Article 12: Class 1 device item notification – process, documents and timeline. The 7 elements must still live in the quality system of the manufacturing site, for 3 reasons: KGMP system documentation must be self-consistent with the product technical content; re-evaluation and post-market inspection trace back to the product technical file; and when an expanded intended use or a class upgrade is pursued later, having no master document means writing from the beginning. GRZAN recommends managing Class 1 products on the standard that the document exists but is not submitted.

A master document plus tailoring costs less than writing one dossier per project. The same manufacturing site often holds products from Class 1 to Class 4. Building the master Technical Document on the IMDRF STED structure and tailoring submission versions per Korean class and pathway concentrates the recurring workload of item updates, changes and medical device standard code (UDI-DI / UDI-PI) data maintenance in one place.

4. Practical recommendations

• Run a gap scan against the 7 elements before entering translation. After collecting the existing technical documentation, mark each of the 7 statutory elements under Article 2, Paragraph 2 for presence, location and evidence strength; produce the gap list before Korean localization starts, so weak evidence is found before translation finishes.
• Check the Korean item standard specifications first for testing specifications. Items with standard specifications map directly; items not covered require self-set test specifications with the justification written into the Technical Document (practical estimate).
• Keep the principle of operation and the mechanism of action as separate documents. The former goes into the Technical Document, the latter into the substantial equivalence comparison table; both must be traceable to the same technical rationale, see Article 22: Substantial equivalence documentation – how to select the comparison device.
• Finalize the Technical Document and the labeling texts together. When the instructions for use are finalized, finalize the Korean texts of the container, outer packaging and leaflet layers together, aligning labeling items with Articles 20 to 23; see Article 24: Korean medical device labeling and IFU requirements.
• Keep a master document for Class 1 products as well. The master document only needs to be touched in 4 situations – a new intended use, a class upgrade, an item update, or re-evaluation – so maintaining it costs less than writing one ad hoc.

5. Verification checklist

• □ Completeness of the 7 statutory elements: check item by item against Article 2, Paragraph 2 of the Medical Device Act; all 7 elements have independent sections with no merged omissions.
• □ Raw material traceability: cross-check material grades, suppliers and test reports; one-to-one correspondence with the models in the Technical Document.
• □ Testing specification basis: query whether the item has a Korean standard specification; mapped directly where one exists, documented justification for the self-set specification where none.
• □ Principle of operation wording: compare the object of the statement with the mechanism of action (MoA); not mixed, both traceable to the same technical rationale.
• □ Instructions for use consistent with labeling: compare the three labeling layers line by line against the Technical Document; wording consistent, no additional claims.
• □ Responsibility for the Korean translation: verify the countersigning party; countersigned by the quality manager of the licence holder.
• □ Class and submission requirement: determine by class whether the Technical Document must be submitted; Class 1 exempt from submission, Class 2 and above submitted per pathway.
• □ Master document usability: check the master version and item group coverage; covers all models within the item group with traceable version numbers.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team prepares MFDS-compliant technical dossiers, coordinates KGMP documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com