SBA SinoBio Access
EN RU IN

Evidence-centred market access

Connecting validated Chinese biomedical technologies with unmet needs in Russia and India.

SinoBio Access helps professional users evaluate Chinese biomedical technology. Every parameter is labelled by its source, and every regulatory claim shows its verification status. Manufacturer-provided information is clearly marked.

Explore solutions → Methodology & Evidence
100% Sourced

Every claim mapped to manufacturer IFU or peer study

Grade A~U

Multi-tiered evidence grading framework

3 Frameworks

China NMPA • Russia RZN • India CDSCO

Zero Bias

Document discrepancies disclosed transparently

WHO & CE-IVD Focus

Global (EN)

English-language technical dossiers and evidence-based analysis for international laboratories and distributors.

Current market • Active
Росздравнадзор (RZN) Focus

Россия / СНГ (RU)

Регистрация, импорт, валидация лиофилизированных тест-систем и доказательная база для специалистов РФ.

Switch market →
CDSCO & NTEP Alignment

India (EN-IN)

Laboratory evaluation, ambient cold-chain resilience (2–28°C), and regulatory import dossiers for India.

Switch market →

How we work

A consistent, source-labelled workflow applied to every technology and every market.

🏷️

Label every claim

Manufacturer statements, external evidence and discrepancies are tagged with verifiable badges so the source is always visible.

📊

Show market status

Registration, import, evaluation and service status are shown per market, defaulting to "not checked" until independently verified.

🔒

Keep documents private

Manufacturer technical files and IFU documents are never leaked or published openly; access is controlled via time-limited signed links.

Read the complete 4-step methodology →

Featured solution: tuberculosis molecular diagnostics

The iFIND TBR + IFQ workflow: Automated qPCR detection with MDR resistance profiling.

🧪 Step 1: Prep Sputum / BAL Sample Lysis • Sputum / BAL • DNA Extraction • Buffer Ingestion ~15 mins 🔬 iFIND TBR Cartridge 1: Screen MTB + RIF Screen IS6110 (M. tuberculosis) IS1081 / IS1087 ⚠ rpoB (Рифампицин / RIF) Primary Screen 🧬 iFIND IFQ Cartridge 2: MDR MDR Resistance katG (Изониазид / INH) inhA (Изониазид Low) gyrA (Фторхинолоны / FQ) MDR Profiling 📋 Report Clinical • MTB Pos/Neg • RIF Sens/Res • INH Sens/Res • FQ Sens/Res Validated

iFIND TBR + IFQ Molecular Workflow

  1. 1 Specimen
    Sample Collection & Lysis Sputum or alternative respiratory specimen. Automated or manual lysis per protocol.
  2. 2 Cartridge 1
    iFIND TBR (Primary Screen) Detection of M. tuberculosis complex DNA and rifampicin-resistance markers.
    IS6110 IS1081 / IS1087 rpoB
  3. 3 Cartridge 2
    iFIND IFQ (MDR Profiling) Expanded resistance detection for isoniazid and fluoroquinolones.
    katG inhA gyrA
  4. 4 Report
    Clinical Interpretation Integrated fluorescent quantification evaluated together with clinical context.
Evidence Boundary Note: All parameters are manufacturer-provided (iFIND). IS1081/IS1087 target conflict and detection time discrepancy (85 min vs ≤120 min) are unresolved. Local regulatory status is not verified. This diagram is for educational purposes.

Clinical & Evidence Context

Early evidence cluster for molecular tuberculosis detection, including detection of drug resistance markers (RIF, INH, FQ). All technical parameters are provided by the manufacturer and are clearly labelled. Local registration status is not verified.

  • Target Genes: IS6110, IS1081/IS1087, rpoB, katG, inhA, gyrA
  • Turnaround Time: 85 mins (Claimed) vs ≤120 mins (Doc discrepancy)
  • Format: Fully closed disposable cartridges with pre-loaded freeze-dried reagents

Solution areas

Technologies organised by clinical area. Only active categories are shown.

Markets

Market-specific organisation for Russia and India, plus a global view.

Global

English-language overview of Chinese biomedical technology with global context.

Russia

Registration, import, laboratory verification and evidence for Russian professional users.

India

Laboratory evaluation, throughput, regulatory and import questions for India.

Evidence approach

How claims are labelled and sources are verified.

Each claim carries one of four statuses: manufacturer-provided, externally supported, discrepancy identified, or pending verification. Read the evidence policy →

Manufacturer-provided information Supported by an external source Document discrepancy identified Local regulatory status not verified

Submit an unmet need

Tell us about a clinical or laboratory need that current options do not meet. We will match it against available technology.

Submit a requirement

Subscribe to evidence updates

Receive notifications when new evidence or verification status changes are published. Double opt-in.

Latest insights