GHTF Issues Final Guidance on Medical Device Regulatory Model
The Global Harmonization Task Force (GHTF) has published final guidance advocating global convergence of medical device industry regulation as the organization reforms itself into a new entity with reduced industry influence.
The document, The GHTF Regulatory Model, compiles recommendations of its five study groups on pre-market evaluation, post-market surveillance and vigilance, quality systems, auditing and clinical safety and performance. The GHTF intends for the document to be used by regulators, Conformity Assessment Bodies and manufacturers; the roles and responsibilities of National Competent Authorities, Conformity Assessment Bodies and manufacturers are all spelled out, as well.
Key elements of the GHTF regulatory model, according to the guidance, are risk-based pre-market controls, a post-market vigilance and surveillance system, a quality and risk management system encompassing a device’s life cycle, and a regulatory audit process to assess conformity.
Aspects of the model still under development at the GHTF include unique device identifiers, combination products, definitions and classifications of field safety corrective actions, and change management.
The GHTF Steering Committee published this latest guidance in order to integrate the organization’s existing documents, as well as related materials such as international standards, regulatory model components not yet developed, and GHTF documents currently under development.
An integrated document covering all aspects of a global medical device regulatory model was first proposed in 2008 at a GHTF steering committee meeting in Malaysia.