Manufacturing medical devicesRegulatory considerations

Dr Ying Huang Inspector, Office of Manufacturing Quality (OMQ) Monitoring and Compliance Group, TGA !ABEC - Canberra

21 August 2014 1

ABEC - Canberra

Topics➢Role of the Office of Manufacturing Quality (OMQ) ➢Basic requirements for a manufacturer ➢Risk-based program of manufacturer assessment

– Regulate risks relating to product – Regulate risks relating to compliance

➢Conclusion

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Role of OMQ

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Australian and overseas

manufacturers are assessed prior to

supply of goods and are then regularly

reviewed

Inspections against conformity assessment

procedures (ISO 13485) and other standards (e.g.

sterilisation standards)

Quality manufacturing

On-site inspections of manufacturers and compliance

verifications (desktop

assessments)

ABEC - Canberra

Basic requirements for a manufacturer➢Manufacturer applies a relevant conformity assessment procedure (CAP)

to demonstrate: • Compliance with Essential Principles (EPs); and

• Implementation of an effective Quality Management System (QMS)

➢Essential Principles • 14 principles for performance and safety, including:

• General risk management;

• Clinical evidence;

• Others

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Risk-based program of manufacturer assessment

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The TGA regulatory framework:

The risks involved with therapeutic goods can be divided into: 1. Risks relating to the product. 2. Risks relating to compliance. Compliance risks relate to the risks involved if a manufacturer or sponsor fails to comply with legal requirements (either unintentionally or intentionally)

ABEC - Canberra

Risk-based program of manufacturer assessment

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Different types of QMS:

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Part 4 Production Quality Assurance

Part 5 Product Quality Assurance

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ABEC - Canberra

Regulate risks relating to product

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Part 1–Full Quality Assurance for manufacturing including design and development

Documents to define the QMS and records to show the system has been applied (clause 4)

Management controls (clause 5)

Resource (human, infrastructure and work environment) management (clause 6)

Design & development control (subclause 7.3)

Purchase: outsourced processes and suppliers (subclause 7.4)

Production and service provision (subclause 7.5)

Measurement, analysis and improvement processes (clause 8)

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ABEC - Canberra

Regulate risks relating to compliance Independent and periodic inspection of a manufacturer:

• By OMQ : ▪ Specifically for combination

products: • Medicines • Animal origin • Microbial substance • Blood components

▪ Types of Inspections • Full • Partial / Surveillance • Unannounced

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And / Or • By recognised third parties: ▪ EU Notified

Bodies; and ▪ CMDCAS

Registrars (for Health Canada)

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Regulate risks relating to compliance

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Desktop assessment➢An alternate way to assess the quality of manufacturing of medical devices ➢The assessment criteria are the same as the on-site inspection. ➢Further on-site inspection may be recommended pending on the desktop

assessment outcome. ➢Benefit:

• Reduce regulatory burden; and • Efficiently utilise resources.

ABEC - Canberra

Regulate risks relating to compliance

➢Monitor post-market adverse events – Regulatory requirements—notification (subclause 8.5.1 of ISO 13485) ▪ Adverse-event reporting & recalls; and ▪ Significant changes in device or QMS

➢Undertake a program of laboratory compliance testing

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To complement the inspection program, other areas of TGA:

ABEC - Canberra 11

Conclusion

1. The TGA manages the risks associated with medical devices by regulating: • Risks relating to product through product assessment and inspection of

manufacturers; and • Risks relating to compliance through post-market compliance activities

including unannounced inspections for problem/complaint investigations. 2. The Office of Manufacturing Quality (OMQ) contributes to TGA’s objectives

through the implementation of the inspection program. 3. ISO 13485 QMS standard has been specified by the conformity

assessment standards order as a tool to assess the manufacturer's QMS.

Thank you for your attention.