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.

REGULATORY & MARKET CONTEXT

Why demand is rising (2025–2026)

A cluster of regulatory changes in Australia and Canada, together with evolving global diagnostic consensus, is driving structured procurement of clinical body-composition devices in hospital and aged-care settings. The following context reflects publicly available regulatory instruments and clinical guidelines; buyers should verify current requirements with their compliance advisors.

  • Australia — Aged-Care Quality Standard Outcome 5.5 (Nov 2025)

    Updated Aged-Care Quality Standards require that residential aged-care providers conduct malnutrition screening using validated tools for all residents. Objective body-composition measurement via BIA supports the validated-tool requirement and provides a documented audit trail for Quality Standard compliance. (verify current regulation)

  • Australia — Expanded Quality Indicator (QI) Program: Unplanned Weight Loss

    The aged-care QI Program requires quarterly reporting of unplanned weight loss events across residential facilities, with dietitian-reviewed care plans for affected residents. Consistent body-composition monitoring underpins both the detection of unplanned weight loss and the clinical documentation required for dietitian input. (verify current regulation)

  • Canada — Ontario Fixing Long-Term Care Act, s.15: Nutrition Screening

    Ontario's Fixing Long-Term Care Act requires long-term care homes to conduct nutrition screening on admission and at least every three months thereafter. Validated BIA provides the objective body-composition data to support structured nutritional-risk documentation at each screening interval. (verify current regulation)

  • Canada — CIHI ICD-10-CA Malnutrition Coding (E40–E46, effective 2026)

    Canadian Institute for Health Information updates to ICD-10-CA malnutrition coding (codes E40–E46) increase the need for objective body-composition evidence to support accurate case coding. Body-composition data from validated BIA strengthens clinical documentation and the coding audit trail for malnutrition diagnoses. (verify current regulation)

  • Global — GLIM Diagnostic Criteria: Reduced Muscle Mass as a Phenotypic Pillar

    The Global Leadership Initiative on Malnutrition (GLIM) criteria define reduced muscle mass as one of three phenotypic criteria required for a malnutrition diagnosis. BIA-derived skeletal muscle index is an accepted measurement method for this phenotypic pillar, driving adoption of clinical body-composition analysers across hospital and aged-care settings globally.

BUYER Q&A

Procurement questions, answered

The three concerns most frequently raised by hospital and aged-care procurement officers, and how Asaptic addresses each within the principal-reseller, deposit-first structure.

Buyer concern Asaptic's answer
Regulatory registration
ARTG (Australia) / Health Canada MDEL + MDL (Canada)		 Asaptic sources exclusively from factories whose specific device models appear in the TGA ARTG register or Health Canada MDALL database — verified directly in the official government databases before any factory is engaged. For each engagement, Asaptic supplies behind an already-registered brand's ARTG listing or Health Canada Medical Device Establishment Licence (MDEL) and Medical Device Licence (MDL), and carries the full compliance documentation package. Buyers receive the verified registration numbers to confirm independently.
Clinical validation vs DXA
Body-composition accuracy for clinical use		 Multi-frequency BIA correlates strongly with dual-energy X-ray absorptiometry (DXA) for lean mass and body-fat assessment in clinical populations — a finding supported by peer-reviewed literature across hospital and aged-care cohorts. Asaptic sources from manufacturers whose devices are 510(k)-cleared by the US FDA and / or hold ARTG and MDALL registrations, and provides clinical validation data and published correlation studies as part of the compliance document package for each device model sourced.
After-sales & calibration
Ongoing service and measurement integrity		 Asaptic structures after-sales service and calibration support via established regional partners in Canada and Australia. Service scope, calibration intervals, and the responsible regional contact are documented per shipment in the compliance package — so procurement teams have a clear service chain before the devices enter clinical use. Calibration records are maintained per device for regulatory audit purposes.
What risk class does a clinical bioimpedance body-composition analyzer fall under in Canada and Australia? Under Health Canada's Medical Devices Regulations, clinical bioimpedance analyzers typically fall in Class II, requiring a Medical Device Licence before sale. Under TGA's ARTG framework, comparable devices are generally classified as Class IIa, requiring ARTG registration before lawful supply in Australia. Both classifications require a formal licence or registration, while documentation and review pathways differ between jurisdictions.
Does a TGA ARTG listing automatically satisfy Health Canada MDL requirements? No. TGA ARTG listing does not automatically grant a Health Canada Medical Device Licence. Health Canada accepts comparative review applications where evidence from comparable regulatory frameworks, including TGA, FDA, and CE marking, can support the submission and may streamline review. The comparator evidence must be explicitly cited and structured to match Health Canada's submission format.
Is ISO 13485 required from the manufacturer for both Canadian and Australian registrations? Yes for both markets. Health Canada requires ISO 13485 certification from an accredited body; for Class II-IV MDL applications since 1 January 2019, this must be MDSAP-certified ISO 13485:2016. TGA requires valid ISO 13485 from a TGA-recognised Conformity Assessment Body for Class IIa devices, and also accepts MDSAP audit reports.
Can the same IEC 60601-1 electrical safety test report be used for both Health Canada and TGA submissions for a BIA device? Generally yes, provided the test report is issued by an accredited testing laboratory and covers applicable national deviations for each jurisdiction. Canada adopts IEC 60601-1 through CSA C22.2 No. 60601-1; Australia adopts it through AS/NZS IEC 60601-1. Both follow the same base standard and national deviations are typically minor for body-composition devices. Confirm with each regulatory authority.
What does a compliant compliance document package for a BIA shipment include? Every shipment includes the verified MDALL licence number for Canada, verified ARTG registration number for Australia, ISO 13485:2016 certificate with scope, Certificate of Conformity, Factory Audit Summary, Bill of Lading cross-reference for recall traceability, and clinical validation data and published DXA correlation studies per device model. Buyers receive the verified registration numbers and are directed to verify independently.
Can the buyer independently verify the regulatory registration numbers? Yes. Both databases are public: Health Canada MDALL at mdall.hc-sc.gc.ca and TGA ARTG at tga.gov.au/resources/artg. All numbers are sourced from official government database queries.
Does the US Section 232 tariff apply to BIA device shipments to Canada or Australia? No. Section 232 applies to US imports. Shipments from China direct to Canada or Australia do not route via the United States, so US Section 232 tariffs do not apply.
How does multi-frequency BIA compare to DXA for clinical accuracy? Multi-frequency BIA correlates strongly with DXA for lean mass and body-fat assessment in clinical populations, supported by peer-reviewed literature across hospital and aged-care cohorts. Devices sourced are 510(k)-cleared by the US FDA and/or hold ARTG and MDALL registrations. Clinical validation data and correlation studies are provided per device model.

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