Request route assessment
For projects where target markets, registration sequence, dossier reuse, and timing priorities are not yet clear.
Email for route assessmentContact
Start by choosing the right regulatory question
If the target market is known, the product is moving, review comments have arrived, or an innovation/IVD pathway is still uncertain, choose the closest entry point. The first discussion helps clarify direction and key gaps, but does not replace formal regulator or notified body decisions.
Consultation Entry
Three common entry points
Each entry point maps to a different internal follow-up tag, so sales, regulatory engineers, and project owners can route the matter faster.
Submit a review issue for initial diagnosis
For projects with NB, FDA, or local authority comments that need root-cause and remediation planning.
Email review issueAssess an innovation or IVD pathway
For IVD, POCT, software, AI, or new-technology products where feasibility and evidence routes matter early.
Email innovation pathwayTeam Contact
Contact points
If the right entry point is unclear, send it to the central inbox and we can route it internally.
Central inquiry desk
LLINS Tech
info@llins-tech.com Include the product, target market, current issue, and timing context in your first note.Shanghai office
Regulatory project coordination
info@llins-tech.com +86 21 3356 1520 Room 1115, Building A, Xuhui Vanke Center, No.55 Ding'an Road, ShanghaiHangzhou office
Registration documentation and project support
info@llins-tech.com +86 189 6648 5232 Room 1012, Tianheng Building, 1509 Binsheng Road, Binjiang District, HangzhouHelpful information for a first note
A short first message works best when it includes
target markets, device type, timing expectations, testing / clinical / QMS documentation state, and whether any review comments or representative needs already exist.Before The Call
These four inputs usually make the first discussion more useful
Target markets
Whether the plan is for one market only or a coordinated EU, US, Canada, Australia, or Southeast Asia approach.
Product type and stage
Whether the device is defined, tested, IVD, software, AI-enabled, or already in clinical or performance work.
Timing pressure
Whether financing, trade shows, channel commitments, review response deadlines, or customer demand are driving the schedule.
Current documentation state
How complete the technical file, QMS, testing, clinical/performance materials, and review communication records already are.
Email First