HEALTH CANADA · TGA CERTIFIED FACTORIES

Bioimpedance Device Sourcing for Hospital & Aged-Care Procurement in Canada & Australia

Factory-direct clinical BIA sourcing from Chinese manufacturers holding Health Canada Class II MDALL licences and TGA Class IIa ARTG registrations. Verified in the official government databases. Document package included with every shipment.

Submit a Specification Brief → Sourcing Overview

WHAT WE DO / CLINICAL BIOIMPEDANCE SOURCING

Asaptic sources bioimpedance and body-composition analysers — including multi-frequency BIA, segmental analysers, and bedside BIA units — directly from Chinese factories holding Health Canada Class II MDALL licences and TGA Class IIa ARTG registrations. We serve hospital and aged-care procurement teams in Canada and Australia. Regulatory certificate numbers are verified in the official government databases and included in the compliance document package with every shipment.

Where to source bioimpedance devices for Canadian and Australian hospitals?

Asaptic sources directly from factories holding Health Canada Class II MDALL licences and TGA Class IIa ARTG registrations, serving hospital and aged-care procurement teams in Canada and Australia. Every certificate number is verified in the official government databases — MDALL at mdall.hc-sc.gc.ca and ARTG at tga.gov.au/resources/artg — before any factory is engaged. The compliance document package, including verified licence and registration numbers, is included with every shipment.

CLINICAL INDICATIONS COVERED

MUST

Malnutrition Universal Screening Tool — BIA supports objective nutritional-risk stratification across hospital admission cohorts.

MNA-SF

Mini Nutritional Assessment–Short Form — validated for aged-care and community settings; BIA provides the objective body-composition inputs.

Sarcopenia Risk (EWGSOP2)

European Working Group on Sarcopenia in Older People consensus criteria — muscle mass quantification via BIA is an accepted diagnostic input.

Post-Surgical Nutrition Monitoring (ERAS)

Enhanced Recovery After Surgery protocols require serial body-composition monitoring — bedside BIA units support ward-based assessment without patient transfer.

ICU Fluid-Balance

Phase-angle and extracellular water ratio monitoring via bioimpedance supports fluid-overload detection and de-resuscitation decisions in critical care.

DEVICE CATEGORIES

Multi-frequency BIA (MF-BIA) Segmental body-composition analysers Bedside BIA units Handheld BIA Phase-angle monitoring devices

CERTIFICATION GATE

Three certifications. Every factory must clear all three.

Asaptic qualifies only factories whose devices appear in the Health Canada MDALL database, the TGA ARTG public register, and hold a current ISO 13485:2016 certificate with scope covering the relevant device category. Factories that cannot be verified in the official government database are not engaged — regardless of what documentation they present independently.

Health Canada

Class II Medical Device Active Licence (MDALL)

What it is: Health Canada's Medical Devices Active Licence Listing — mandatory for Class II medical devices sold in Canada. Publicly searchable at canada.ca.

Our gate: We query the MDALL database by manufacturer name and device model. Only factories whose specific device model appears with an active licence number pass. Licence number is recorded in the compliance document package.

Buyer action: Verify the device in the MDALL database at mdall.hc-sc.gc.ca using the licence number provided in the document package to confirm independently.

TGA

Class IIa Medical Device (ARTG)

What it is: Australia's Therapeutic Goods Register — entry required for Class IIa medical devices legally supplied in Australia. Publicly searchable at the TGA website.

Our gate: We verify the factory's device listing in the ARTG by sponsor name and ARTG number. Sponsor details and ARTG entry number are included in the document package.

Buyer action: Verify the ARTG entry at tga.gov.au/resources/artg using the ARTG number provided — confirming registration, sponsor identity, and device description against the shipped product.

ISO

ISO 13485:2016 Quality Management

What it is: The international quality management system standard for medical device manufacturers and their supply chains. Required by both Health Canada and TGA as evidence of systematic quality control.

Our gate: We verify the ISO 13485 certificate scope explicitly covers the BIA device category — not a generic QMS covering unrelated product lines. Currency (expiry) is checked. Scope limitations are flagged.

Buyer action: ISO 13485 certificate with certification body name is included in the document package — verifiable via the certification body's public register.

VERIFICATION PROTOCOL

Primary-source verification only. No factory screenshots accepted.

Asaptic's certification verification is conducted against the official government databases — not factory-supplied documents, screenshots, or third-party certification summaries. This is not procedural caution; it reflects how procurement officers will verify the same information during their own due diligence. We verify first so the audit trail exists before the buyer asks for it.

The three-step protocol below is applied to every factory before engagement, and the outputs are assembled into the compliance document package that ships with every order.

1 · Primary-Source Database Check

MDALL and ARTG queries are run directly in the Health Canada and TGA public databases. No factory-supplied screenshots or PDFs are accepted as primary evidence. The specific device model, manufacturer name, and licence / ARTG number are recorded verbatim from the official database entry.

2 · Certificate Chain Audit

ISO 13485 certificate scope is reviewed to confirm the BIA device category is explicitly covered. CE MDR technical index is reviewed where applicable. The importer chain — factory → sponsor / importer of record — is verified for both Health Canada and TGA pathways to confirm no unlicensed intermediary in the chain.

3 · Document Package Assembly

The compliance document package for each shipment includes: verified MDALL licence number (or ARTG registration number), ISO 13485:2016 certificate with scope, Certificate of Conformity (CoC), Factory Audit Summary, and Bill of Lading cross-reference for recall traceability. The package is assembled before shipment release — not retroactively.

SOURCING PROCESS

Five steps from specification brief to document release.

Asaptic operates as principal, not broker. We take a 30% deposit at the Proforma Invoice stage — this is procedural, not a commercial concession. The deposit reserves a certified factory production slot against a qualified factory that has cleared the certification gate. Balance is released against the Bill of Lading, so the buyer does not release full payment before shipment confirmation.

The five steps below apply to every clinical BIA engagement. Timeline from Specification Brief to Proforma Invoice is typically 5–10 business days. Production and document assembly runs according to the agreed production schedule confirmed at Step 3.

Step 1 · Specification Brief — buyer submits device category, clinical indication, volume, and destination market (CA / AU). Asaptic returns a fit confirmation within 24 hours — confirming which BIA categories have verified MDALL / ARTG factory coverage. Step 2 · Factory Qualification — Asaptic shortlists 2–3 certified factories whose specific device models appear in the MDALL or ARTG database for the buyer's specification. Factory Audit Summaries are shared for buyer review. Step 3 · Proforma Invoice & 30% Deposit — Proforma Invoice issued on selected factory and device model. 30% deposit secures the certified factory production slot. Balance payable against Bill of Lading — no full prepayment before shipment. Step 4 · Production & Document Assembly — production runs to agreed schedule. Compliance document package is assembled in parallel: MDALL / ARTG verification, ISO 13485 cert, CoC, Factory Audit Summary. Documents verified before release. Step 5 · Shipment & Document Release — goods shipped direct to Canada or Australia (no US routing). Full compliance document package released to buyer on Bill of Lading confirmation. Recall traceability chain is complete from factory to buyer at point of delivery.

RISK ALLOCATION & BUYER PROTECTION

How risk is allocated. What Asaptic is and is not.

Procurement officers need to understand the commercial structure before committing budget. The four panels below answer the questions that matter for hospital and aged-care tender submissions.

Principal

Risk Allocation

Asaptic acts as the principal on every sourcing engagement — not an agent, not a matchmaker. We bear the sourcing risk, the factory qualification risk, and the document assembly risk. If a factory we have engaged cannot produce a verifiable MDALL or ARTG registration, we do not pass that exposure to the buyer. The buyer's contractual counterparty is Asaptic, not the Chinese factory.

Structure

Who We Are Not

Asaptic is not a broker who connects buyers to factories and steps aside. We are not a grey-market importer sourcing devices with unverified certification claims. We are a direct principal-reseller: we qualify factories, assemble compliance documentation, and take commercial responsibility for the supply chain. Procurement officers submitting to hospital tender panels can represent Asaptic as a verified principal supplier, not an intermediary.

Tariffs

Section 232 Exposure

Section 232 is a US customs measure — it applies to goods entering the United States, not goods shipped to Canada or Australia. Asaptic does not route CA or AU shipments through the United States. There is no Section 232 tariff exposure for Canadian or Australian hospital procurement teams buying through Asaptic. This is a common concern from buyers who have read US trade-policy coverage — it does not apply to your jurisdiction.

Documents

Document Package FAQ

Can the buyer independently verify the MDALL or ARTG number? Yes — both databases are public. Does the document package support recall traceability? Yes — the Factory Audit Summary and CoC chain trace to the factory; the B/L cross-reference traces to the specific shipment. Are document numbers from factory screenshots? No — all numbers are taken from the official government database query output. What if a document is found to be incorrect after shipment? Asaptic, as principal, bears the remediation obligation.

PROCUREMENT GUIDES

Guides & Resources

ENGAGE

Start with a Specification Brief

Submit your device category (MF-BIA, segmental, bedside, handheld), clinical indication, procurement volume, and destination market (Canada or Australia). Asaptic returns a factory fit confirmation and MDALL / ARTG coverage assessment within 24 hours — no commitment required at this stage.

Submit a Specification Brief