Increasingly complex regulatory requirements and rapidly evolving technology can create headaches for medical device developers. Our regulatory consulting team is a unique resource in managing this complexity, through strategic guidance and input into the product development process, leading to more a mature regulated product, and increasing the opportunity for better compliance outcomes. We can achieve these outcomes by:

• Regulatory/clinical/reimbursement strategy development for global markets including: US, Europe, Canada, Japan, China, Australia, and APAC countries

• Regulatory gap analysis and preparation of mitigation plans prior to regulatory submission

• Regulatory assessment to address changes in regulatory requirements and standards

• Facilitating premarket engagement with regulators

• Rapid pivot to address post-market issues and interactions with regulators

• Develop regulatory and administrative appeals strategy

Have recent interactions with medical device regulators identified some gaps in your knowledge? If so, our experienced regulatory consulting team can deliver training to help develop the skills necessary to avoid common pitfalls, understand regulatory requirements and develop clinical evidence to support business needs (product development, regulatory, marketing and reimbursement).

• TGA Sponsor Requirements

• Compliance with TGA Essential Principles/EU Essential Requirements – General safety and performance/General health, safety and performance

• Overview of regulatory frameworks (US FDA, Japan PMDA, Health Canada, EU CE mark, Australia TGA, China NMPA, Singapore HSA, and other APAC markets)

• Clinical evidence overview

• Creation of technical files/design dossiers/STED/DHF/DMR

• Compliance with ISO 13485 QMS

• Risk management in compliance with ISO 14971 during product development

• Post market process overview (AE, PMS, recalls, reporting)

If you are an overseas company with no registered business in Australia, you need to appoint a local Australian sponsor for compliance to both medical device regulations and registration. Our regulatory consulting team can act as your Australian medical device sponsor to meet and show compliance with Australian TGA Medical Device and IVD Device Regulations and the Therapeutic Goods Act. Our post-market regulatory support ensures you meet Australian regulatory requirements. Working as part of your team we can:

• Submit Manufacturers Evidence

• Apply for inclusion of the product(s) on the Australian Register of Therapeutic Goods (ARTG)

• Fulfill post-market reporting to TGA

  • Incidents, adverse events and near misses

  • Overseas regulatory action

  • Manufacturer investigations

  • Annual reporting (Class III, AIMD, or Class IIb implantable)

• Strategies to implement CAPA and facilitate TGA close-out

• Provide product distribution and management services in line with regulatory requirements

Our experienced regulatory consulting team assists our global clients overcome regulatory hurdles, reducing risks and facilitating compliance to achieve a successful submission. To streamline market access, we can:

• Assistance with application processes

• Create or review your technical documentation/design dossier/STED/DHF/DMR/QMS to ensure compliance with regulatory requirements

• Create or review your Clinical Evaluation Report

• Develop documentation for regulatory and administrative appeals

• Complete your Declaration of Conformity

• Provide preparation and support for onsite audit

• Medical device reimbursement applications with public and private payers