Japan is the world’s third largest market for medical devices, after the US and Europe. Ironically, many of the world’s medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are relatively less complex than those of the US and Europe and other markets.
Regulatory filing requirements for medical devices in Japan start with passing what is called the Pharmaceutical and Medical Device Law (PMDL). To facilitate better understanding of the language and to make regulatory filing requirements for medical devices in Japan easier, the Pharmaceuticals and Medical Devices Agency (PMDA), which is a part of the Ministry of Health, Labor and Welfare (MHLW) issues English language documents.
The “Toroku” registration processThe Japanese system for complying with regulatory filing requirements for medical devices has two different modes for domestic and foreign medical device manufacturers. For Japanese medical device companies, a registration system known as “Toroku”, which is formulated under the PMDL, applies. According to this process, domestic manufacturers whose manufacturing processes are based in Japan have to register their manufacturing facilities with the local authorities at their respective prefectures. For foreign manufacturers, the same have to be registered with the PMDA.
The step-by-step processThis is how the step-by-step process for regulatory filing requirements for medical devices in Japan takes place:
The FDA introduced the idea of process validation for medical devices with the idea of improving the quality of pharmaceuticals and medical devices. From its rudimentary form that was conceived in 1987, process validation for medical devices has undergone changes to accommodate more types of devices and more processes into the validation.
Why is process validation for medical devices necessary?
In simple terms, validation is the ability of a medical device to demonstrate that a procedure, process and activity will consistently lead to the expected results. For the FDA; process validation for medical devices is all about establishing documented evidence which will offer a high degree of assurance that a specific process will consistently produce a medical device product that meets its pre-determined specifications and quality characteristics.
Process validation for medical devices is a requirement of the current GMP regulations for medical devices, 21 CFR Part 820 and is applicable to the manufacture of medical devices.
A host of factors influences the quality of a product in medical device manufacturing. Some of these are:
- Adequate product and process design
- Control of the process
- In-process and end-product testing
- Selection of quality parts and materials
The guidelines published by the FDA provide a framework for medical device manufacturers to build a holistic approach to process validation for medical devices. This is broad in nature, since the particulars of process validation vary from one manufacturer to the other because of many factors, such as
- The nature of the medical product (e.g., sterile vs. non-sterile)
- The complexity of the process
- The local regulatory requirements
- The age of the product (e.g., new invention vs. similar to an existing product)
The FDA recommends that the manufacturer:
- Prepare a written validation protocol which specifies:
- The procedures to be conducted and the data to be collected
- Purpose of data collection
- A sufficient number of process repetition to demonstrate reproducibility
- An accurate measure of variations during repeated process runs
- The test conditions that include best case and worst case scenarios called as “most appropriate challenge” conditions
- Validation documentation requirements to include evidence of the suitability of materials and the performance and reliability of equipment and systems
- Monitor and document key process variables and analyze the data collected to establish:
- The variability of process parameters for individual runs
- Whether or not the equipment and process controls are adequate to assure that product specifications are met
- Utilize finished product test data and in-process test data to obtain quality attributes and in establishing variability
- Where finished (or in-process) testing cannot adequately measure certain attributes, process validation should utilize the details of each system in production and by document the observed results
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