Japan: Medical Device Design Controls Under the New PAL

Japan’s New Pharmaceutical Affairs Law (PAL) will include revisions to the Good Manufacturing Practice (GMP) regulations for medical devices. Under the New PAL beginning April 2005, all medical devices manufacturers will need to meet the new Japanese GMP regulations, based on ISO 13845:2003. Included in this regulation are new detailed requirements for device design procedures.

All Marketing Authorization Holders (MAH) are required to designate a Good Quality Practice (GQP) Controller; this Controller will be in charge of overseeing GMP and product design compliance. The GQP Controller will ensure that any changes in the design of a medical device do not negatively impact the safety and efficacy of the device.

A company’s product design team, comprised of employees from the manufacturing plant, regulatory department, sales department and design department, will each contribute input for the design. The team will be required to develop and document a step-by-step plan for developing and carrying out the design, establish a timetable, and determine SOPs for design revision procedures.

The design process will consist of two main processes: design verification and design validation. Design verification involves the comparison of the design input (information on intended use, regulatory and safety requirements, similar devices and risk management) with design output. Verification includes the examination of performance tests, in vitro and in vivo tests, labeling and packaging tests, and others. Design validation is conducted at the final stage of the design process and is used to confirm that the design of the device satisfies its intended use. Validation tests are usually conducted under actual or simulated conditions, such as a clinical trial.