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January 15, 2026
Approximately 5 minutes
Manufacturing Medical Devices and IVDs in Australia – TGA Regulatory Requirements
Manufacturing Medical Devices and IVDs in Australia – TGA Regulatory Requirements
Regulatory Framework
Manufacturing is regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. All manufacturers (including those overseas supplying to Australia) must ensure devices are produced in a manner that consistently meets the Essential Principles for safety, quality, and performance. Compliance is demonstrated primarily through a quality management system (QMS) meeting ISO 13485:2016 requirements, with TGA accepting certification from accredited bodies under specified conditions. Source: Manufacturing medical devices and IVDs - TGA
Quality Management System (QMS) Obligations
- Manufacturers must establish, document, implement, and maintain a QMS covering all stages of the product lifecycle.
- The QMS must address risk management (ISO 14971), design controls, production processes, supplier controls, corrective and preventive actions, and post-market surveillance.
- Australian-specific elements include procedures for TGA adverse event reporting, recall management, and compliance with labelling/advertising rules.
GMP Compliance and Evidence
- ISO 13485 Certification: Accepted as evidence of GMP compliance when issued by an accredited certification body (e.g., under MDSAP or equivalent programs).
- Class-Specific Requirements:
- Class I (non-sterile, non-measuring): Self-declaration of GMP compliance.
- Class I sterile/measuring, Class IIa, IIb, III: Third-party ISO 13485 certification or direct TGA assessment required.
- Audits: TGA conducts surveillance, initial, and for-cause audits of manufacturing facilities.
Key Manufacturing Controls
- Traceability: Full chain from raw materials to finished product and distribution.
- Validation: Processes (including sterilisation), software, and design must be validated where necessary.
- Change Management: Changes affecting safety/performance must be controlled, documented, and reported to TGA if significant.
- Sterile Devices: Validated sterilisation processes per relevant standards (e.g., ISO 11135 for ethylene oxide).
Post-Market Manufacturing Responsibilities
- Maintain systems for vigilance: adverse event reporting, field safety corrective actions, and recalls.
- Conduct ongoing monitoring, internal audits, and management reviews.
- Report significant changes to QMS or manufacturing processes to TGA where required.
International Manufacturers
Overseas manufacturers must meet the same standards as Australian ones. TGA accepts certain international certifications but may require additional evidence or audits to verify compliance with Australian-specific requirements.
Detailed information on QMS implementation, GMP evidence, audit processes, recognised standards, and obligations for different device classes is provided in the official TGA guidance on manufacturing medical devices and IVDs. Source: Manufacturing medical devices and IVDs - TGA
These requirements ensure manufactured devices maintain quality and safety throughout their lifecycle in the Australian market.
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