Countries looking to develop a medical device regulatory regime should take a total lifecycle approach starting with listing products and implementing premarket controls, the Asian Harmonization Working Party says.
Regulations should address clinical trials during the product development stage, registration and licensing as a device is placed on the market, maintenance and corrective actions taken while the device is in use and changes made to the device as it nears the end of its lifecycle, the group says. A new offers recommendations and tools for bridging the gap between emerging markets and those with established device regulations.
Basic regulatory controls should include registration and licensing of device dealers and products, premarket controls, quality management systems, risk-management processes and postmarket surveillance. Once devicemakers are registered or listed, countries should build a database of devices on the market that includes the manufacturer’s contact information, AHWP says.
The group recommends using the definition of “medical device” developed by the Global Harmonization Task Force, which takes into account the many different forms devices may take. Once a general definition is put into place, regulators should look at issuing policies to clarify what will and will not be regulated as a device.
AHWP also recommends using harmonized standards for postmarket vigilance and QMS—such as ISO 13485 on device quality management systems. QMS auditing can be outsourced to a third party, the group says.
Premarket assessment of devices is a huge regulatory burden that not all economies will be prepared to take on, AHWP notes. Countries without the resources to perform the reviews should start by maintaining a list of devices on the market and then add requirements for detailed review of safety and performance as resources permit. A transparent and predictable risk-classification system should be an important consideration in device reviews, the group says.
As for overall responsibility, AHWP recommends national legislation to provide oversight and funding, supported by regulations and guidelines issued and implemented by a national authority.
AHWP’s 23 member countries include China, India, South Africa, Saudi Arabia, Thailand and Chile.