GuidelinesBy procedure2026.11.06
Veterinary Medical Device Class 2 Technical Documents — A Manufacturer Request Table Linking the Application Items to the Data under Article 6(1) of the Review Notice
Asking the manufacturing source to ‘send everything needed for approval’ tends to bring back only catalogues and certificates. A Class 2 import approval consists of the application items in Chapter 3 of the Approval Notice and the technical document and safety and effectiveness data under Article 6(1) of the Review Notice. This guide fixes the application model and components first, then sets out a request table linking each application item to the documents to request from the manufacturing source and the supporting review data, the order for checking identity, and the data waiver provisions by equivalent product category.
Key takeaway — The unit of the request is the application item, not the file. Fix the application model and components, and link each item in Chapter 3 of the Approval Notice (product name, shape and structure, raw materials, manufacturing method, performance and intended use, method of use, packaging unit, precautions, storage method and shelf life, test specifications, manufacturing source) to the documents to obtain from the manufacturing source and the supporting data under Article 6(1) of the Review Notice. Then you and the manufacturing source can see what is missing in the same table.
This article is based on the Rules on the Handling of Veterinary Pharmaceuticals, etc. (MAFRA Ordinance No. 741, in force 31 October 2025), and the APQA notices Regulation on the Approval, etc. of Veterinary Medical Devices (No. 2020-19) and Regulation on the Review of Technical Documents, etc. for Veterinary Medical Devices (No. 2020-18), as checked on 6 October 2026. For deciding the route, see classification and application route, and for the distinction between the company line and the product line, see import business licence and product import approval or notification first.
Which bundle of data is needed
Article 7(4) of the Handling Rules requires a person seeking manufacturing or import approval, etc. for a veterinary medical device to undergo a review with data on the technical documents and data on safety and effectiveness, and provides that safety and effectiveness data may be omitted for an item that is substantially equivalent in structure, principle, performance, intended use and method of use, etc. to an item already approved. The detailed requirements are set by the APQA Commissioner, and that is the Review Notice.
Article 3(1) of the Review Notice defines the scope of review as devices for which manufacturing or import product approval (including change approval) is sought, and paragraph (2) defines as subject to review including safety and effectiveness data: devices with a new structure, new performance, new intended use or newly developed; devices whose main technical characteristics in Annex 1 differ so as to have a significant effect on safety and effectiveness; and, where the approval condition is changed from export-only to domestic sale, devices falling under the preceding points. Paragraph (3) categorises Class 2 and above as new, improved or equivalent products using the substantially equivalent item comparison table in Annex 4 and the criteria in Annex 3, and Article 6(3) provides that submission of data may be waived according to that categorisation.
So even for Class 2, the scope of data forks in two. If the device is categorised as an equivalent product, the technical document data are central; if it is categorised as a new or improved product, safety and effectiveness data also come under review. Requesting ‘everything’ without deciding which branch applies leaves the manufacturing source unable to tell what to look for.
Step 1: Fix the application model and components
Tabulate the model name, options, accessories and components to be introduced into Korea. Article 9 of the Approval Notice provides that the product name is entered as the item name and model name, and that where an export name needs to be stated separately it is written in parentheses. If the overseas sales model name differs from the Korean model name, request manufacturer documents explaining the relationship. Article 3(1) of the same notice provides that products in the same product group may be applied for under one approval, and paragraph (3) that for a multi-component veterinary medical device the product name and class of each device are all entered.
If a component is added or a contacting part changes, the subject of the test data may differ. This step checks that the actual configuration of the finished product to be imported, the application, the instructions and the test data all point to the same product.
Step 2: Link the application items to the manufacturer documents and the supporting review data
| Application item (Approval Notice Chapter 3) | Source documents to request from the manufacturing source | Supporting data under Article 6(1) of the Review Notice | What to compare on receipt |
|---|---|---|---|
| Product name (Article 9): item name, model name | Model list, explanation of the relationship to the export name | Point (i)(a) intended use data | Item name and class in Annex 1 of the Scope Notice |
| Shape, structure and dimensions (Article 10): overview, photographs; for electrical and mechanical devices, operating principle, electrical ratings, type of protection, safety devices, block diagram, insulation diagram, embedded software | Drawings, photographs, electrical specifications, circuit and insulation data, software description | Point (i)(c) electrical and mechanical safety data (including software) | Application model and drawing revision number match |
| Raw materials or ingredients and quantities (Article 11): name, raw material and specification per part and material | List of raw materials (BOM), material and specification of contacting parts | Point (i)(b) physical and chemical characteristics, point (i)(d) biological safety data | Material and specification of contacting sites identical to the test data |
| Manufacturing method (Article 12) | Sterilisation method, conditions and packaging method; animal-derived ingredient information | Point (ii)(b) stability data (including ageing of sterilised materials) | Whether the device is sterile |
| Performance and intended use (Article 13) | Performance specifications, supporting data for the intended use | Point (i)(a), point (i)(g) performance data | Test evidence for each claimed performance |
| Method of operation or use (Article 14) | Original instructions, pre-use sterilisation conditions, software screens | Point (i)(a) | Korean instructions draft matches the original |
| Packaging unit (Article 15) | Manufacturing source's packaging unit | For imports, entered as ‘packaging unit of the manufacturing source’ | |
| Precautions for use (Article 16) | Original warnings and cautions | Intended use and any unsupported claims | |
| Storage method or shelf life (Article 17) | Storage conditions, basis for setting the shelf life | Point (ii)(b) stability data | Storage conditions and import establishment facilities |
| Test specifications (Article 18): selected from the Annex 2 test items, criteria and methods, name, number and year of issue of the standard | List of applied standards, complete test reports | Point (i)(h) test specifications, basis for setting them and measured values; point (i)(e) radiation; point (i)(f) electromagnetic | Standard number and year of issue, model name tested |
| Manufacturing source (Article 19): country of manufacture, manufacturer name, address; for contract manufacturing, the commissioning party and the manufacturer | Manufacturing site information, contract relationship | Proof of contract manufacturing under Article 5(3)(ii)(d) of the Handling Rules | Matches the manufacturing site on certificates and labels |
Where the device is categorised as a new or improved product, add rows in the same way for the safety and effectiveness data under Article 6(1)(ii) (origin and development history, stability, clinical trial results or clinical data for Class 1 and 2, overseas use status, comparison with similar products).
Step 3: Request descriptive documents and supporting data separately
Descriptive documents are the source texts that fill in the application (instructions, drawings, specifications); supporting data are the test data and assessment data that meet the requirements of Article 6(2) of the Review Notice. Before translating, check first whether anything is missing from the originals. For test data, obtain the complete report and its annexes rather than the certificate cover page, and mark the issuing body, date of issue, applied standard, model name covered, list of raw materials and whether attachments are included. The issuer, identity and three-year requirements for test data are covered separately in the next article.
| Request table column | Example row |
|---|---|
| Application item | Raw materials (Article 11) |
| Document requested | List and specifications of contacting parts |
| Model covered | D-01 |
| Status held | Material name only; specification not stated |
| Open question | Specification and whether the supplied part can be identified |
Separating documents obtainable from the manufacturer's sales team from those needing confirmation by its technical or quality team makes clear who answers. This table is not a statutory form but our own tool for collecting documents.
Fictional example: same main unit, different contacting part
Suppose the main unit of fictional product D matches the model name in the manufacturer's test data, but the Korean supply configuration includes a different contacting part. Checking only that the main unit model name matches leaves the list of raw materials and the scope of components out of step with the test data. Article 6(2) of the Review Notice requires test data to have the same model name and list of raw materials as the product applied for, so where there is a difference, review whether the data can still be submitted, or whether additional evidence or testing is needed. Correcting the model designation alone does not resolve an actual difference in specification. This example is not the review outcome for a specific product.
Common misunderstandings
| Common explanation | What the provisions provide | What to check |
|---|---|---|
| Class 2 has a fixed bundle of tests | Article 6(1) prescribes the applicable data according to the product's characteristics. | Electrical, contacting, sterile, software |
| An equivalent product needs no data | Article 6(3) only provides that data may be waived; categorisation by the comparison table comes first. | Annex 4 comparison table |
| A certificate is test data | Article 6(1)(i)(h) requires data on test specifications, the basis for setting them and measured values. | Complete report and Annex 2 items |
| We submit the CE technical documentation as it is | The application is prepared under the Chapter 3 entry instructions. | Item-by-item comparison table |
| Clinical trials are always needed for Class 2 | Class 1 and 2 may substitute clinical data, and necessity is decided under Article 3(2). | Whether new structure, new performance or new intended use applies |
The item structure of human-use technical documents can be compared with the technical file writing guide, and the operation of requests to overseas manufacturers with the overseas manufacturer document request guide. Veterinary devices rest on different notices, so item names are not carried over as they are.
Documents that speed up the review if prepared before enquiring
- List of models, options and components to be introduced
- List of the manufacturer's instructions, drawings and specifications with revision numbers
- List of test data provided by the manufacturer (issuing body, date of issue, model covered)
- Information on the existing item to be compared against
Please mention veterinary medical devices in your message when you use the veterinary technical document review enquiry. We will set out the document gaps and the identity questions and support the request to the manufacturing source. Agency fees are quoted separately according to the product configuration and the scope of review and application. The scope of services is on the veterinary medical device services page.
Prepared and sources checked: 2026-10-06. Sources: Rules on the Handling of Veterinary Pharmaceuticals, etc. Article 5(3)(ii), Article 7(4), Article 16(1) · Regulation on the Approval, etc. of Veterinary Medical Devices Articles 3, 4, 8 to 19 · Regulation on the Review of Technical Documents, etc. for Veterinary Medical Devices Article 3, Article 6(1) to (3). The request table, comparison table and fictional example are our own practical tools and do not replace the statutory submission list for an individual item.
Frequently asked questions
- Q. If it is Class 2, do we have to run every test?
- Article 6(1) of the Review Notice prescribes data on intended use, physical and chemical characteristics, electrical and mechanical safety, biological safety, radiation safety, electromagnetic compatibility, performance, and test specifications and measured values, as applicable according to the product's characteristics. Electrical and mechanical safety data are not required for a device that does not use electricity. In addition, Articles 3(3) and 6(3) provide that Class 2 and above are categorised as new, improved or equivalent products, and that submission of data may be waived for equivalent products and the like.
- Q. Can we submit the manufacturer's CE technical documentation as it is?
- The application must be prepared under Article 4(1) of the Approval Notice in accordance with the entry instructions in Chapter 3 of the same notice (Articles 8 to 20), and the review data must meet the requirements of Article 6 of the Review Notice. Overseas technical documentation can be used as source material to fill those items, but the model name, list of raw materials and test specifications must be checked against the content of the Korean application.
- Q. Are clinical trial data always required?
- Article 6(1)(ii)(c) of the Review Notice prescribes data on clinical trial results and provides that for Class 1 and 2 items clinical data may be submitted instead. Whether safety and effectiveness data are needed at all depends on whether the device falls within the review scope in Article 3(2) (new structure, new performance, new intended use, newly developed, etc.).
- Q. How is the manufacturing method entered?
- Article 12 of the Approval Notice provides that it is entered as ‘according to the manufacturing method of the manufacturing source’, with additional entries for sterile devices (sterilisation method, sterilisation conditions, packaging method, etc.) and, where the device contains or uses animal-derived ingredients, the animal's name, country of origin, age, part used, processing steps, ingredient name, etc.