Regulatory Compliance

Regulatory & Compliance Disclaimer

 

1. Nature of Products

APS Medical Technology supplies bovine and porcine-derived biological materials, including pericardium, tendon, and bone, intended for use as components in the manufacture of medical devices. These materials are supplied as raw or processed biomaterials and are not finished medical devices.

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2. Regulatory Clearance Required

The biomaterials supplied by APS are not approved, cleared, or authorised for direct clinical use. Any incorporation of APS’ biomaterials into a finished medical device requires the manufacturer to obtain appropriate regulatory clearance or approval in each country or jurisdiction in which the device is to be marketed or used, including but not limited to:

 

• Australia — Therapeutic Goods Administration (TGA)

• United States — Food and Drug Administration (FDA)

• European Union — CE Marking under the Medical Device Regulation (MDR 2017/745)

• China — National Medical Products Administration (NMPA)

• Other applicable national or regional regulatory bodies

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3. Manufacturer Responsibility

It is the sole responsibility of the device manufacturer or end user to:

 

• Determine the suitability of APS’ biomaterials for their intended application

• Conduct all necessary validation, testing, and biocompatibility assessments in accordance with applicable standards, including ISO 10993

• Comply with all relevant regulatory requirements in the jurisdictions in which they operate

• Ensure that their manufacturing processes and quality systems meet the requirements of ISO 13485 or equivalent standards

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4. Standards Compliance

APS operates in accordance with ISO 13485 (Quality Management Systems for Medical Devices) and ISO 22442 (Medical Devices Utilising Animal Tissues and their Derivatives). Compliance with these standards by APS does not confer regulatory approval on any finished device incorporating APS materials, nor does it replace the manufacturer's obligation to comply with applicable regulations independently.

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5. No Clinical Advice

Nothing on this website or in any APS documentation constitutes clinical, medical, or regulatory advice. Manufacturers are advised to consult with qualified regulatory affairs professionals and legal counsel before commercialising any medical device incorporating APS’ biomaterials.

Export Controls & Trade Compliance Notice

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1. Overview

APS Medical Technology exports biological tissue products internationally, including to China and other markets. The export of animal-derived biological materials is subject to a range of Australian and international laws and regulations. By engaging with APS for the purchase or receipt of exported goods, customers and partners acknowledge and accept responsibility for compliance with all applicable trade and biosecurity requirements in their jurisdiction.

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2. Australian Export Regulations

The export of animal-derived biological materials from Australia is governed by:

 

• The Biosecurity Act 2015 (Cth) and associated Biosecurity Regulations 2016

• The Export Control Act 2020 (Cth) and associated Export Control Rules 2021

• Requirements of the Australian Department of Agriculture, Fisheries and Forestry (DAFF)

APS holds all required licences and permits for the lawful export of its products from Australia. Export documentation, including health certificates and export permits where required, is provided in accordance with applicable Australian law.

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3. Importer Responsibilities

It is the sole responsibility of the importer or receiving party to:

 

• Obtain all necessary import permits, licences, and regulatory approvals required in the destination country

• Comply with local biosecurity, quarantine, and customs requirements

• Ensure that the importation and use of animal-derived biological materials is lawful in their jurisdiction

• Maintain records of importation in accordance with local regulatory requirements

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4. Sanctions & Restricted Parties

APS does not knowingly supply products to individuals, organisations, or countries subject to Australian, United Nations, or other applicable international sanctions. Customers are responsible for ensuring they are not listed on any sanctions register and that the end use of APS products complies with all applicable trade controls.

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5. Animal-Derived Material Declarations

APS provides full traceability documentation for all animal-derived materials, including species of origin, country of sourcing, and processing information, to support customers in meeting their import declaration and regulatory obligations. Customers requiring specific documentation should contact APS prior to placing an order.

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6. Contact

For questions regarding export documentation, trade compliance, or country-specific requirements, please contact APS directly.

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General Disclaimer

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1. Informational Purpose Only

The content published on the APS Medical Technology website, including all product descriptions, technical data, application examples, and supporting materials, is provided for general informational purposes only. It does not constitute a warranty, representation, or guarantee of any kind regarding the suitability, performance, or fitness of any APS product for any specific application or purpose.

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2. No Guarantee of Suitability

APS makes no representations or warranties, express or implied, that its biomaterials are suitable for any particular medical device application, manufacturing process, or end use. The performance of biological materials may vary depending on processing, handling, sterilisation, and end-use conditions that are outside APS' control. Manufacturers and researchers are solely responsible for evaluating product suitability for their specific applications.

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3. Regulatory Variation by Jurisdiction

Regulatory requirements governing the use of animal-derived biological materials in medical devices vary significantly between countries and jurisdictions. Information provided on this website reflects APS' understanding of general regulatory frameworks and does not constitute regulatory advice. APS does not warrant that its products meet the specific requirements of any particular jurisdiction. Users are responsible for determining and complying with all applicable local regulations.

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4. Technical Information

Technical data, specifications, and application information provided by APS are based on internal testing, published literature, and industry experience. This information is subject to change without notice. APS does not guarantee the accuracy or completeness of technical information and recommends that customers independently verify all data relevant to their applications.

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5. Limitation of Liability

To the maximum extent permitted by applicable law, APS Medical Technology, its directors, employees, and agents shall not be liable for any direct, indirect, incidental, consequential, or special damages arising from the use of, or reliance on, information provided on this website or in any APS documentation, or from the use of APS products in any application.

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6. Third-Party References

This website may reference third-party standards, regulations, publications, or organisations. Such references are provided for informational convenience only and do not constitute endorsement by APS. APS is not responsible for the accuracy or currency of third-party content.

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7. Changes to This Page

APS reserves the right to update or amend these notices at any time without prior notice. Continued use of this website or APS products following any such changes constitutes acceptance of the updated terms.

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8. Governing Law

These notices are governed by the laws of the State of Victoria, Australia. Any disputes arising in connection with these notices shall be subject to the exclusive jurisdiction of the courts of Victoria.