Before an imported microcurrent device enters China, the local agent must manage both the overseas product facts and the proposed China market position. Translating an existing manual is not enough if parameters, programs or intended purpose remain inconsistent.
1. Corporate and authorization documents
Clarify the relationship between the manufacturer, brand owner, Chinese applicant or agent, and the model covered by the authorization. Confirm the production address, signing authority and the person responsible for technical responses.
2. Original technical package
- Complete original manual and specification.
- Current, voltage, frequency, waveform, pulse width and load data.
- Electrode structure, material, area, spacing and body contact.
- Software or App program-to-parameter matrix.
- Main unit, handpieces, accessories and consumables.
- Protection functions, test reports and risk information.
- Overseas website, training and market-purpose materials.
3. Proposed China version
The Chinese product name, model, instructions and intended purpose should be jointly confirmed by the agent and the manufacturer. A low-function paper version cannot be created while the imported hardware and overseas software remain unchanged.
4. Translation and terminology
Terms such as infusion, stimulation, therapy, relief and repair may carry different regulatory implications. Translation must not mechanically weaken the original meaning or describe an effect the product does not achieve. A bilingual terminology table reviewed by the manufacturer is recommended.
5. Feasibility and stop conditions
- Can the manufacturer provide complete real-output data?
- Can the China version adjust purpose or software where needed?
- Are signing, notarization and legalization timelines manageable?
- Do overseas materials conflict with the China position?
- Can the production product remain identical to the assessed sample?
If the manufacturer refuses core parameters, cannot confirm the production version or requires the Chinese agent to hide genuine overseas functions, the project should pause.
An imported classification result has lasting value only when the manufacturer, agent and actual product share the same factual basis.