This week’s guidance is rooted in two basic concepts: device manufactures should monitor and analyze the effectiveness of tools employed to demonstrate product and QMS conformity; and two, device manufacturers should actively seek feedback from their customers, including post-product performance of products.
The bottom line in regards to compliance with Ministerial Ordinance 169 (MO 169) is quite simple: Equipment employed for the monitoring, measuring, testing, and/or inspection of medical devices must be properly maintained and calibrated. And this requirement applies to your suppliers as well.
Although customer property and the management and handling of customer-supplied material is not important for FDA, that is clearly not the case for MHLW. And, preservation of products is important in all regulatory environments, so create a robust SOP with sufficient granularity to address all Article 52 requirements.
Identification and traceability are basic foundations associated with product realization, manufacturing, and ultimate distribution of finished medical devices. And the device world takes generally accepted identification and traceability requirements, and places them on steroids.
This week’s guidance is all about the manufacturing control of sterile medical devices, validation, and more validation.
For device manufactures failing to comply with Ministerial Ordinance 169, “gomen nasai” will be the first three words received from PMDA, followed by “your company’s medical devices are not approved for introduction into Japan’s device market place.”
Purchasing and supplier management is one area where a supplier’s poor performance can have a direct impact on the safety and efficacy of a finished medical device. In fact, a bad supplier can easily result in a product recall.
Medical devices that are safe and effective are rooted in a robust design and it is impossible to design a medical device that is safe and effective, in its intended use, without the establishment of a well-documented design and development process.
“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.
