Medical device organizations that manufacture products outside of Japan, but plan to market within this geography, are required to obtain accreditation by the Minister of Health, Labour and Welfare (MHLW), or what is referred to as Foreign Manufacturer Accreditation (FMA).
A critical step in receiving an FMA includes undergoing proper inspection of manufacturing buildings and facilities by Japan’s Pharmaceutical and Medical Devices Agency (PMDA). When a medical device or in vitro diagnostics (IVD) organization has operations outside of the country, it is necessary to rely upon the firm’s Marketing Authorization Holder (MAH) or Designated MAH (D-MAH) to directly apply for FMA status on behalf of the foreign manufacturer. (Please click here to read out blog post on the importance of MAH/D-MAH designations in Japan).
How do you know which manufacturing facilities to register?
Medical devices are composed of many parts, and each product follows its own unique pathway during the manufacturing process, sometimes touching multiple facilities. However, an FMA only requires that facilities that are “key in the manufacturing process” be registered and noted in the “Manufacturing Facilities” section within a regulatory submission (product dossier). Manufacturing facilities that should be noted in the submission pertain to sites which have the function of product design, key assembly processes, sterilization, and domestic storage of the final product. These facilities must show responsibility and accountability for following the product realization process under Quality Management System (QMS) investigation.
In principle, each manufacturer has only one FMA number. However, as some manufacturers operate under a contract status – especially those who offer sterilization services – multiple FMA numbers are given. For this reason, it is important to clarify with your organization as to which number will be continuously maintained as some FMA numbers will no longer be effective if an outsourcer ends a contract.
The following table (Table 1) summarizes the facilities that are required to be registered by manufacturers. As previously noted, if manufacturing sites are overseas, these sites are required to apply for an FMA.
|Manufacturing Process||Product Line|
(other than right columns)
|Medical Device Class I||Stand-Alone Program||Storage Media of Stand-alone Program|
|Key Manufacturing Process (Key Assembly Process)||X||X||N/A||N/A|
|Domestic Storage Site of Final Product||X||X||N/A||X|
Table 1: Manufacturing registration categories
(* If the product design controller operates at the same address as the MAH, registration is not required.)
If registration is required, the following documents will need to be furnished upon the FMA submission:
- A medical certificate from a physician, or an explanation of materials, that proves that the FMA representative meets all qualification requirements; and
- A curriculum vitae of the person who is responsible for operations of the manufacturing establishment; and
- A visual representation (drawing/map) of the manufacturing site.
The PMDA does not provide estimated timelines for the processing of accreditations for foreign manufacturers, however, it has been relayed by many manufacturers that the average processing for approvals averages five months.
It is important to note that an FMA must be renewed every five years and should be submitted approximately five months prior to its expiration.
The above is only a snapshot of important business factors for Japanese medical device manufacturers. For our next blog in the “Focus on Japan Series: Part IV,” we will highlight QMS operations in Japan.
NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to global medical device development, including identifying the best-fit regulatory strategy that will lead to product success. Please contact us at email@example.com or visit our regulatory consulting webpage here to learn more.