Glossary
■AMAH/DMAH (Appointed/Designated Marketing Authorization Holder)
"A foreign companies, who are trying to get an approval or certificate for their product in Japan, are required to appoint a MAH ( has to be an appropriate licensed MAH according to the classification of the product to be handled) within Japan when applying the approval in order to take a necessary measures to prevent any health related hazards on the application for approval of the product. The appointed ( designated ) MAH is called AMAH"
■Approval
Those who wants to manufacture and sell the product (Drugs, Medical devices) in Japan have to get an approval by the Minister of Health, Labour and Welfare for each product to be manufactured and marketed. Approval by the Ministry of HLW is not necessary for the products categorized as "general medical device" or "designated controlled device".In order to get the approval, one needs to submit the application to PMDA
■Certificate
Those who wants to manufacture and sell the designated controlled medical devices (= controlled medical devices which meets the agreement standards ) have to get a certificate by registered certification bodies for each product. In order to get the certificate, one needs to submit the application to one of the registered certification bodies. If a "controlled device" does not meet the agreement standards, the device is then categorized as specially controlled medical device and one need to get an Approval (PMDA).
■Clinical trial for MHLW approval
A clinical study that is conducted in order to attach its results to the submission of the approval application. This trial is necessary if the product is not equivalent to the already approved devices in terms of its structure, principles and/or intended use etc.
■Controlled medical device
-This category includes the medical devices that are not the Specially controlled medical devices and that are required an appropriate control for them sue to their risks. (life threatening and/or harmful effects on health if they fail) - The Minister of H,L and W designates these devices by referring the opinions of Regulatory/Food sanitation council.
■Designated controlled medical devices
The controlled medical devices which are designated with certain standards by the minister of H.L and W
-This category includes the medical devices that are not the Specially controlled medical devices and that are required an appropriate control for them sue to their risks. (life threatening and/or harmful effects on health if they fail) - The Minister of H,L and W designates these devices by referring the opinions of Regulatory/Food sanitation council.
This system no longer exist. (note: [ I.C.C for clinical trial ] is a different story and it does exist). Under the previous law, before April 2005, many foreign medical device companies without a local office in Japan chose to export their products to Japan via an ICC. An ICC acted as an “agent” for the foreign medical company and was responsible for preparing product registration documents, ensuring the safety and efficacy of products and post-marketing surveillance, among others. The ICC system allowed foreign companies to register their medical products in their own name and hold the shonin (“approval”) themselves, rather than allowing the distributor to hold the shonin. Under the new low, since April 2005, Appointed Marketing Approval Holder (AMAH) is obliged to fulfill a role including the ex ICC's primary responsibility. (see AMAH)
■JAAME(Japan Association for the Advancement of Medical Equipment)
One of the third party certification bodies. This organization used to be one of the two registration / approval reviewers (PMDEC and this JAAME) and JAAME used to review "me-too devices" until April 2004. Since then, JAAME has played a role as an provider of various medical-device related public formation and seminars, as well as the certification body.
Link to http://www.jaame.or.jp/
■JFMDA(Japan Federation of Medical devices Association)
http://www.jfmda.gr.jp/e/index.html
■MAH (Marketing Authorization Holder)
Those who market, lease and/ or grant the products (which are manufactured or imported) .
-MAH has to be responsible for the product distribution
-MAH is required to be responsible for the quality of the product and manufacturing.
-MAH is required to actively collect, to analyze, to evaluate the safety (information) and to take an appropriate measures sequentially
-MAH is entitled to distribute, lease and/or grant the products, which it manufactured or imported, ONLY to other licensed MAHs of medical device, manufacturers and retailers・rental dealers.
■Manufacturer
Those who manufacture the products upon the order from MAH. The manufactured products can be sold, rented and/or granted only to MAH or Manufactuer
■Manufacturer for labeling.etc.
Those who only do the labeling and storage in the manufacturing process, are required to get a license for "Manufacturer for labeling etc."
■Marketing Supervisor -Genral etc. - of MAH
A MAH has to staff a person who takes responsibility of the quality control and post-marketing-safety management within the MAH company. This person is called the Marketing Supervisor -General etc.- of MAH. - To be qualified as this Marketing Supervisor- General, the person has to meet the criteria established by MHLW.
■MHLW(the Ministry of Health, Labor and Welfare)
http://www.mhlw.go.jp/english/index.html
■PAL(Pharmaceutical Affairs Law)
A law established to secure effectiveness and safety of drugs and medical devices. This law restricts the handling and approval/certification of all the drugs and medical devices.
First enforced in August 1950, and the latest revision was in April 2005
■PMDA(Pharmaceuticals and Medical Devices Agency;(Incorporated Administratiive Agency)
The ONLY organization in Japan who does review the product registration applications (including the clinical trials) for Approval (both for pharmaceutical and medical device products). It also manages all the adverse event/side effect reports and provides the safety related information to public.
PMDA was established, in April 2004, in an effort to create a more efficient and transparent medical device registration review process. The PMDA was formed by merging three already-existing organizations: (1) the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), (2) the Organization of Pharmaceutical Safety and Research (OPSR) and (3) the Japan Association for the Advancement of Medical Equipment (JAAME).
A MAH has to staff a person who does the quality control within the MAH company. This person is called Quality controller.
- The Quality controller has to meet the criteria (according to the classification of the products to be handled ) established by MHLW.
■Registered Third Party Certification Bodies
Organizations which review the certification application, and give a NINSHO (certification ) to medical devices and/or InVitro diagnostic drugs. They are registered to MHLW. There are 12 of them as of July 2005.
■Rental dealer
Rental dealers of medical devices are divided into 2 groups:
-Those who want to rent out "Specially controlled medical devices" or "Designated maintenance and management required medical devices" are required to get a license issued by prefectrural governor.
-Those who want to rent out "Controlled medical devices" - except for the" Designated maintenance and management required medical devices" need to notify its business to prefectrural governor.
■Repairer
One is required to get a license for Medical Device Repairer in order to do the repair business
■Retailer
Retailers of medical devices are divided into 2 groups:
-Those who want to sell "Specially controlled medical devices" or "Designated maintenance and management required medical devices" are required to get a license issued by prefectrural governor.
-Those who want to sell "Controlled medical devices" - except for the"Designated maintenance and management required medical devices" need to notify its business to prefectural governor.
■Safety controller
A MAH has to staff a person who does the post-marketing-safety control within the MAH company. This person is called Safety controller.
- The Safety controller has to meet the criteria (according to the classification of the products to be handled ) established by MHLW.
■Specially controlled medical device
- This category includes the medical devices that are required an appropriate control for them due to their high risks (life threatening and/or serious health hazard may occur if they fail in spite of the appropriate usage under the appropriate indication for use.) -The Minister of H,L and W designates these devices by referring the opinions of Regulatory/Food sanitation council.
| Risk class | Classification of medical device | Registration category |
| Class I | General medical devices | Notification (self-certification) |
| Class II | Designated controlled medical devices | Third-party certification |
| Class III | Controlled medical devices | Approval |
| Class IV | Specially controlled medical devices | Approval |
| Classification of MAH | Workable medical devices |
| 1st class MAH | General medical devices, (designated) controlled medical devices, specially controlled medical devices |
| 2nd class MAH | General medical devices, (designated) controlled medical devices |
| 3rd class MAH | General medical devices |
*3 Manufacturer license / accreditation of foreign manufacturer
| Category of manufacturer license |
| Cell/tissue medical devices, specified biological medical devices |
| Sterile medical devices |
| General medical devices |
| Packaging, labeling and/or storage |
| General medical devices | No license required |
| (Designated) controlled medical devices | Notification for retailer |
| Specially controlled medical devices | License for retailer |
