AHWP Medtech Regulatory Guide Stresses Flexibility

The Asian Harmonization Working Party (AHWP) has developed a "playbook" to help its member economies develop medtech regulations for their respective regions and to strategically work towards international harmonization.

The playbook contains guidelines and reference tools on how AHWP member economies should implement regulatory controls to realize the benefits of international convergence. It provides a graduated set of controls – from the most basic to the more advanced – proportionate to device risks and across the product's lifecycle.

While the AHWP playbook is primarily based on Global Harmonization Task Force guidance documents and approach, it recognizes the distinct socio-economic backgrounds and the different medical device market profiles of its member economies.

The playbook, therefore, "does not prescribe regulatory controls to a granularity that would render it impractical to implement across the various member economies".

The aim is not to make the AWHP playbook stricter or more lenient in comparison to the approach proposed by the GHTF, but to suit the specific needs of AHWP member economies, said Jack Wong, director of regulatory affairs (Asia-Pacific) at medtech company Terumo BCT Inc.

Some AHWP member economies, for example, may have a higher proportion of reprocessing activities while others may have greater focus on import or export of medtech products. This means each member economy would prefer to adopt different regulatory policies, depending on the controls needed for specific medical device activities in each jurisdiction.

The AHWP recognizes that the implementation processes across its member economies will inevitably vary and that no single set of implementation plans prescribed in the playbook can effectively address the needs of each country.

As the majority of the AHWP member economies tend to import the medical devices used in their regions, the playbook focusses on regulatory control needed for importers and distributors, rather than on medtech manufactures and product development.

Nonetheless, the AHWP believes that each economy should ensure appropriate regulatory controls are effectively established, implemented and maintained in a non-discriminatory manner for all medical devices, regardless of their country of origin.

Guidance And Flexibility

The playbook offers guidance to member economies on developing a basic regulatory framework harmonized with international practices, with the flexibility to permit further developments and enhancements to be done at subsequent stages.

For example, it states that member economies should start with a few key elements (basic regulatory controls), such as: registration or licensing of medical device dealers and products; pre-market controls, such as definitions and qualification of medical device; establishing quality management system and risk management requirements; and post-market vigilance and surveillance.

More advanced controls, such as classification and conformity assessment of medical devices, may be considered later in the implementation process.

Also, the AWHP believes that mere establishment of rules is not sufficient, and each member country should also devote sufficient resources and appropriately qualified people to the establishment, running and continuing evolution of the medtech regulatory system – now and in the future.

While the playbook is intend for AHWP member economies, Wong believes it can also serve as a good reference document for other countries with established medtech regulatory frameworks.

Specifically, it guides member economies on how they should: identify best practices and adapt them to their system; identify key considerations and potential limitations inherent in the system; ensure resources and priorities are aligned to elements of the regulatory framework; accelerate implementation of the regulatory framework, quickly and effectively; and make effective use of limited regulatory resources.

It also provides a policy framework to support of domestic and international trade.

The AHWP explains that the playbook was developed through consultation and represents a consensus view of experts on basic requirements and good regulatory practices for medical devices.

The AHWP currently has member economies beyond Eastern Asia, extending into Middle East, Africa, and even Latin America. Its members include Abu Dhabi, Brunei Darussalam, Cambodia, Chile, Taiwan, Hong Kong, India, Indonesia, Jordan, Saudi Arabia, Laos PDR, Malaysia, Myanmar, Pakistan, China, Philippines, South Korea, Singapore, South Africa, Kuwait, Tanzania, Thailand, Vietnam and Yemen.

(This article also appeared inScrip Regulatory Affairs.)