Designated (specially) controlled medical device :
Certain (specially) controlled medical devices for which the Minister of MHLW sets stipulated registration requirements.
See below link;
DMR (Device Master Record, Seihin Hyojunsho) :
A compilation of records containing the procedures and specifications for a finished device. DMR index (document identifications) needs to be shared with Japan MAH.
FMR (Foreign Medical Device Manufacturer Registration) :
A license required for the actual manufacturing facilities (design, assembly and sterilization) engaged in device production. Japan entity handles the application on behalf of foreign manufacturers. It takes about 1.5 – 2 months from file to issue. It is 5 years valid and need renewal to extend.
Generic Medical Device (Kohatsu Iryo Kiki) :
“Me-too” device. Medical device that structure, method for use, intended use, effectiveness and performance are equivalent to medical devices that have been approved and placed on the market. Registration category of generic medical device applies.
Improved Medical Device (Kairyo Iryo Kiki):
Medical device that falls under neither the New Medical Product Category nor Generic Medical Devices; it does not possess novelty that warrants designation of re-review, but its structure, method of use, intended use, effect or performance is not substantially equivalent to a marketed device. Registration category of improved medical device applies.
Japan Essential Principles:
Japan Essential Principles from GHTF document※1 was introduced in Japanese regulation and all devices shall be in conformity with the EPs. Essential Principles in Japan was revised in 2014 because GHTF published the revised GHTF document※2.
JIS (Japanese Industrial Standards) :
Japan Industry standards established by the responsible minister. Many are MOD or IDT of relevant ISO or IEC standards. Conformity to particular JIS standard is required in the registration of designated controlled medical device as stipulated in the certification requirements (ninsho kijun).
JMDN (Japan Medical Device Nomenclature) :
Nomenclature for medical devices in Japan, developed based on GMDN.
MAH (Marketing Authorization Holder):
A business that markets medical devices in Japan. Importing medical devices in foreign countries and marketing them also require this type of license.
MHLW (Ministry of Health Labor and Welfare) :
The competent authority which regulates and administrates medical devices in Japan.
See below link;
New Medical Device (Shin Iryo Kiki):
Devices determined to have clearly different structures, purposes of use, efficacies, effects or performance from those of approved devices. Registration category of new medical device applies.
See Pre-Market Certification.
PMDA (Pharmaceutical and Medical Devices Agency):
PMDA is Japanese regulatory agency, working closely with MHLW. PMDA conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices and monitoring of their post-marketing safety. They provide relief services for adverse health effects as well.
PMDA is involved in all device approvals and notifications during the product registration process including various pre-submission consultation services.
See below link;
Pre-Market Approval (Shonin):
One of the regulatory clearances MHLW issues after PMDA review for a medical device to be placed on Japan market. Conformity to QMS requirements, which is checked every 5 years in Periodic post-approval inspection, is a requisite to maintain it.
Pre-Market Certification (Ninsho):
RCB issues the certification for a designated (specially) controlled medical device to be placed on Japan market after review. QMS conformity is inspected in periodic post-certification inspection and annual surveillance.
Pre-Market Notification (Todoke):
A notification that MAH submits to MHLW via PMDA when marketing products other than those for which approvals or certifications are necessary.
QMS Ordinance (MHLW Ministerial Ordinance No. 169):
Ordinance issued by MHLW that sets the manufacturing control and quality control standards for medical devices. The ordinance consists of provisions of ISO 13485 and additional Japan specific requirements. It is a reference standard for every party that engages in Japan medical device industry including foreign manufacturers that export devices into Japan market. The ordinance should be referenced in the quality manual.
One of QMS requirements for MAH and manufacturer(s) to tie for the purpose to establish device QMS network.
RCB (Recognized Certification Body, Ninsho Kikan):
A nongovernmental body accredited by MHLW, with the authority to certify designated (specially) controlled medical device as having met the required specifications.
‘Seihin Hyojun Sho’:
See Device Master Record (DMR)
See Pre-Market Approval.
See Pre-Market Notification.