mdi ConsultantsA requirement of ISO13485 (2003) by the Japanese Government authorities
for medical devices in Japan.
We recently obtained information from our Japanese affiliate concerning ISO13485 and what the future requirements will be by the Japanese Governments for medical device suppliers’ exporters. This information will be very important for any company that is presently exporting medical devices to Japan and has not been certified to ISO13485.
- For a new application for an import approval of a medical device under the revised Pharmaceutical Affairs Law (PAL) which will be enforced on April 1, 2005, ISO13485 will be a mandatory requirement.
- For the existing approved medical devices (Shonin), ISO13485 will be a requirement at the time when importers of the approved medical devices submit applications to obtain new business license (Kyoka) in compliance with the revised PAL after April, 2005
Even after the enforcement of the revised PAL in April, 2005, importers of the approved medical devices are permitted to continue to import the approved medical devices until the expiration date of the business license (Kyoka) currently being held by the importers. Importers must renew its business license in every five years. Thus, there will be a grace period until the expiration of the existing five year effective period of the existing business license. At the time when the current business license expires, such an importer must obtain “a new business license” in compliance with the revised PAL. On that occasion of the renewal of the business license, reviews of the approved medical devises will be conducted at the same time with reference to GMP (ISO 13485) investigations (site inspection or document examination) of the approved medical devices at the foreign manufacturing facilities.
Thus, medical devices suppliers/manufacturers currently exporting the approved medical devices to Japan are recommended to contact their Japanese importers to clarify the exact renewal date of the current business license and also to clarify when ISO 13485 will be required for the existing approved medical devises being supplied by foreign manufacturers.
- In case of the approved medical devices to which the GMP investigation was applied as part of the foreign manufacturing approvals, the GMP investigation will be done in less than every five years. Thus, any GMP investigations to be done after April, 2005 will be based on ISO13485.
Remarks
The above information is based on texts used at seminars by the medical devices examination body (the Japanese Association of Advancement of Medical Equipment) and the industrial association (The Japanese Federation of Medical Devices Association). Specific details of regulatory requirements are yet to be announced. Thus, the above statement is subject to changes after further clarification of the regulatory requirements.
For additional information on the above requirements or to answer any questions please contact mdi Consultants, Inc. at [email protected] or call 516-482-9001.