A non-medical-device classification project is not simple document preparation. It starts with the real product and progressively aligns the regulatory pathway, product definition, technical parameters, verification evidence and market communications into a dossier that can be submitted and consistently implemented.
The review level depends on product origin, technical mechanism, applicant and authority requirements. The timeframes below are planning references, not fixed approval deadlines.
Imported products, complex mechanisms or projects requiring national-level determination are generally prepared against the national classification pathway. The final review level is determined by the competent authority and system rules.
Complex projects commonly take about 12–18 monthsEligible China-manufactured products may enter the relevant local pathway according to the company location, actual product and local regulatory requirements.
Commonly about 3–6 monthsActual timing may be affected by dossier completeness, the number of questions, supplementary testing, third-party work and authority processing time.
Each stage has defined client actions and Basic Law deliverables. The next stage starts only after the preceding conclusion can be reviewed and confirmed.
Build a factual baseline that reflects the real product.
Provide product instructions, overview, photographs, operating principle, technical parameters, use videos and existing test information.
Review completeness, product version and visible gaps, and issue an initial material checklist.
Determine whether an executable non-medical pathway exists before full investment.
Confirm actual use, target users, commercial purpose, target market and current project stage.
Assess product-status risk, review level, redesign scope, evidence needs and the boundary of subsequent work.
Align product facts, submission materials and the intended market.
Confirm the product name, intended purpose, version and parameters, and coordinate samples, testing and internal R&D confirmation.
Draft or reconstruct the instructions, product overview, technical requirements, risk analysis and verification-evidence matrix within a non-medical boundary.
Complete the final version, company confirmation and formal filing.
Confirm the submission strategy and complete account, corporate stamp and required authorisations; imported projects add notarised and bilingual documents at the formal stage.
Perform the final consistency review, control document versions, complete system forms and organise the formal submission.
Continue substantiation around questions from the competent authority.
Provide samples, testing, R&D explanations or corporate confirmations when required, and promptly approve response content.
Track the review, organise responses, supplementary testing and additional documents until a classification result or staged regulatory opinion is received.
Project efficiency depends on the product facts, company confirmations and professional dossier remaining on the same version. Clear responsibilities reduce repeated revisions and avoidable waiting.
The final deliverables depend on the product mechanism, dossier condition and agreed scope. Project value is not measured by the number of documents.
Start with the core information that explains the real product. After review, the consultant will request formal materials according to the project stage.
Notarised authorisation is not required for the initial assessment. It is prepared after the pathway is confirmed and the formal project begins.
An existing manual, parameter list and product images are enough to start. Missing materials can be added through the Compliance Center as the project progresses.
Product status, review level and classification results are determined by the competent authority based on the actual product and formal dossier. This page explains a general project process and does not promise a result or fixed timeline for a specific product.
