Pharmaceutical and Medical Device Law (Japan)
Japan’s medical device market authorization process has long been considered one of the most rigorous, lengthy, and intensive in the world. Presently, even though regulations are still stringent, the Pharmaceutical and Medical Device Law (PMDL) has streamlined regulatory requirements in Japan. The ultimate goal of PMDL, which went into effect in November 2014, is to make the registration and approval process even faster than that of the U.S. FDA. Providing access to safe and effective medical devices and diagnostics as quickly as possible is of particular importance since Japan represents the second largest market for medical technology products in the world.
PMDL: Separating Medical Devices from Drugs
PMDL replaces the Pharmaceutical Affairs Law (PAL), the prior mandate for medical device registration requirements in Japan. The amended law provides a device-specific regulatory framework, regulating medical devices separately from drugs in Japan for the first time. Prior to the PMDL taking effect, the PAL required Japanese medical device companies to qualify for domestic manufacturer licenses and mandated that foreign entities must obtain foreign manufacturer accreditations. Now, domestic companies need only register their manufacturing facilities with their local authorities while foreign manufacturers are required to register facilities with Japan’s Pharmaceutical and Medical Devices Agency (PMDA).
Outmoded PAL Requirements
In the past, there were several PAL directives that medical device firms were required to meet that have since been supplanted by PMDL. For instance:
- Foreign manufacturers used to be required to appoint Designated Marketing Authorization Holders to deal with the Japanese Ministry of Health, Labour and Welfare’s Pharmaceutical and Medical Devices Agency (PMDA) division.
- Devices were reviewed based on a four-tier classification system: premarket submission for Class I devices; pre-market certification for specified controlled Class II devices; and pre-market approval for highly controlled Class II, II, and IV devices.
- Registrants had to comply with system requirements outlined in Ministry of Health, Labour and Welfare (MHLW) Ordinance #169, which is primarily based on the ISO 13485 quality management standard.
Current PMDL Requirements
Several other components of the PMDL represent new or substantially different registration and/or compliance rules that foreign device manufacturers must be aware of if they plan to market a device in Japan. In addition to the aforementioned new system of registration for manufacturers of medical devices, some of the new or updated elements of PMDL include:
- A new conformity assessment system for quality management systems (QMS): Quality system conformity is now assessed on a product basis, rather than by facility. A certificate of QMS conformance covers the device/product name to be registered, the product group, and the manufacturing facility. Conformance certificates are valid for five years and, in circumstances where additional devices in the same product groups are listed on the certificates, the facilities listed on the certificates are not subject to additional assessments
- Rules for software as a medical device: While the PMDL requires pre-market certification for some standalone medical software, medical device-related software classified as Class I under PMDA rules is not considered a true medical device. Recently MHLW issued a public comment to show examples of software identified as a medical device. It should be noted that Japanese Medical Device Nomenclature (JMDN) codes for software that qualifies as a medical device have yet to be established by regulators.
- New stringent package insert requirements: For any Class I, II, III, or IV medical device submitted for registration in Japan, a manufacturer must prepare and update the device’s package insert based on current medical literature, safety information, and data sourced from vigilance processes. The package insert information must be included in manufacturers’ applications. Package insert information for Highly Controlled Class IV medical devices must be provided to the MHLW for publication on the PMDA website.
- New formats for pre-market approval applications and pre-market certification: Even though there are only minor changes, the new formats require applicants to list the names and registration numbers of their manufacturing facilities. Sterilization methods and information about manufacturing conditions must also be included. Descriptions of manufacturing process flows and outsourced inspection facilities that were required under PAL are no longer compulsory. However, in order to adhere to the new application format, applicants need to adjust the descriptions of their manufacturing methods on their existing applications within 30 days of their latest quality management system renewal deadlines.
- Rules for transferring pre-market certifications: Under PAL guidelines, transfers of pre-market certifications were not permitted. PMDL, on the other hand, now allows for these types of transfers. In instances where pre-market certification holders have also changed registered certification bodies (RCBs), those organizations must submit new pre-market certificate applications within three months of the date of transfer.
- The scope of third-party certifications has been expanded: PMDL allows more Class II devices and even some Class III and Specified Highly Controlled devices to go through third-party certifications. In fact, the overall intention of PMDA appears to be moving toward more third-party (rather than governmental) certification for Class III devices. Regulators plan to hold evaluation meetings in the future to determine whether or not additional steps should be implemented.
- Changes to marketing authorization holder (MAH) licensing rules: The requirements necessary for an organization to qualify for MAH status have changed under PMDL. The PAL device regulations mandated that an organization was required to implement Good Quality Practice (GQP) and Good Vigilance Practice (GVP) ordinances as well as employ three qualified managers (e.g., Quality Manager, Safety Manager, General Manager, etc.). While the PMDL requires the same manager employment standards, it also requires an MAH’s quality management system to be based on GVP as well as MHLW Ordinance #169. Also, for the first time, a new MAH License category is available for in vitro diagnostic (IVD) devices.
For more information about global quality regulations and standards and to learn how automated quality management software solutions can accelerate your organization’s compliance with regulatory guidelines, visit the MasterControl regulations and standards page.