Do not be that organization that gets stuck buying green catheter handles, when the requirement is for white. Article 61 does not tell device manufacturers what data needs to be collected and analyzed. It is completely up to each organization to decide. Remember, your organization, your data, so you decide what data is important.
It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Manufacturers must be able to gauge the effectiveness of their policies, procedures and processes, and provide objective evidence that their approach to quality and the manufacturing of devices is effective.
Internal audits, regardless of the regulatory environment, are a fundamental requirement for an effective QMS. ISO 13485:2012; 21 CFR, Part 820, and MO 169, each clearly specifies that device manufacturers must plan and perform internal quality audits in order to gauge the overall effectiveness of the QMS.
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.
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.