Service Offerings List
- Feasibility & Preliminary Assessment
Regulatory Landscape Analysis: Identifying which IVD products are permitted for local assembly/filling vs. those strictly requiring full-product importation.
Facility & Infrastructure Evaluation: Determining required cleanroom classifications, warehouse specifications, and local ISO 13485 quality system requirements.
Cost Analysis: Modeling local labor, packaging, registration, and testing fees versus tariff differences on direct imports.
Risk Assessment: Evaluating local supply chain resilience, raw material import restrictions, and local regulatory inspection risks.
- Supply Chain Architecture & Design
Factory Selection: Vendor due diligence and matching with compliant local contract manufacturers (filling/assembly plants).
BOM & Sourcing Strategy: Planning core raw material/bulk export from China paired with local procurement for secondary packaging, labels, and auxiliary materials.
Import/Export Strategy: HS code classification for semi-finished goods, bulk export customs clearance, Certificates of Origin (COO), and bonded warehouse options.
Packaging & Labeling Localization: Reviewing layout and compliance for local language requirements, regulatory warnings, barcodes, and local registration numbers.
- Regulatory & Compliance Consulting
Registration Pathway Guidance: Mapping out registration routes specific to localized production (local manufacturing license vs. import registration).
QMS Guidance: Consulting on ISO 13485 and local GMP compliance, mock internal audits, and preparation for local FDA/authority inspections.
Change Control Management: Updating technical files and risk documentation when changing packaging or assembly locations.
Post-Market Vigilance: Setting up local compliance workflows for complaints, adverse event reporting, and market recalls.
- Commercial & Business Implementation
Contract Negotiation Support: Structuring contract terms between Chinese manufacturers and overseas contract plants (confidentiality, liability allocation, quality indemnification).
Quality Agreement Drafting: Defining incoming quality control (IQC), finished goods inspection standards, and non-conformance handling.
Capacity Planning: Establishing MOQs, lead times, and inventory buffer strategies.
Distributor Financial Modeling: Evaluating margin impact, pricing strategy, and competitive positioning after shifting to localized production.
- Quality Assurance & Operational Support
IQC Standard Operating Procedures: Standardizing acceptance criteria for bulk/semi-finished goods shipped from China to overseas plants.
Finished Product QC & Batch Records: Developing quality control protocols and standardized batch production record (BPR) templates.
Audit & Inspection Management: Coordinating ongoing contract manufacturer audits and third-party inspections.
Post-Sales Protocol: Establishing product recall and field safety corrective action (FSCA) procedures post-localization.