Japan Device Association Lobbies for Flexibility in Laws Regulating Foreign Medical Device ManufacturersAugust 3, 2011 – 4:45 pm
Foreign medical device manufacturers registered in Japan that move their factories or change their corporate identity following a merger or acquisition are required to resubmit a request for accreditation as a foreign medical device manufacturer. Moreover, the companies are not allowed to export devices until they have received their reaccreditation. Not only does this hurt their business, but it could threaten the supply of medical devices to Japan. Forty percent of medical products sold in Japan are imported.
To ensure a stable domestic supply of medical devices, the Japan Federation of Medical Device Associations (JFMDA) has filed a formal petition with the Ministry of Health, Labour and Welfare, and the Pharmaceuticals and Medical Devices Agency (PMDA). The petition, which was filed in July 2011, asks the ministry to “revise the current accreditation system and implement a new registration system,” which would require manufacturers to “only register the name of the company, location and name of the representative” at the time of reaccreditation. Under the current approval system, companies need to go through a rigorous screening at their factories (such as a QMS audit) all over again after submitting the reaccreditation application. The association considers the system redundant and has called for a simpler process that requires no factory audit checks.
“For both the PMDA and applicant companies, the reaccreditation process has been a pain in a neck,” says a JFMDA member, who drafted the petition. “If we can simplify the whole process and just make it paperwork, that will be a great plus for [all parties].”
The petition was filed ahead of the government’s plans to revise the country’s Pharmaceutical Affairs Law (PAL) next year. The JFMDA pushed for regulations that specifically target the medical device industry. The association’s requests include changing the name of PAL to the Pharmaceutical Affairs and Medical Device Law, and adopting a fast-track approval system for upgraded products that have already gone through the device approval process once.
The Ministry has given no indication yet that it plans to accept the petition filed by the JFMDA at the time of the next PAL revision.Miki Anzai