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
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).
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.
-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 Health, Labour and Welfare (MHLW) designates these devices by referring the opinions of Regulatory/Food sanitation council.
The controlled medical devices which are designated with certain standards by the minister of MHLW
"The foreign manufacturer assigns a Japanese company, who has MAH license, as the “Designated MAH” (or “DMAH”). Then the foreign manufacturer makes and submits an application for approval/certification through the DMAH company. In this case, the foreign manufacturer owns the approval/certification, and the DMAH company works as an agent in Japan."
-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.
An ordinance issued by the Ministry of Health, Labour and Welfare (MHLW) to set the requirements for Marketing Approval Holders in Japan for Quality Control.
An ordinance issued by the Ministry of Health, Labour and Welfare (MHLW) to set the requirements for Marketing Approval Holders in Japan for the vigilance & the Post-Market Surveillance (PMS) activities system.
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)
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/
"KYOKA" is a license; in this case for a medical device manufacturer.
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
To market a medical device, it is necessary to have the appropriate class of MAH license. Additionally, to obtain approval(certification) for a medical device, the appropriate class of MAH license is also needed (PAL Article 12, 14).
In other words, it is necessary to be licensed as a MAH in order to obtain medical device approval(certification) and to market in Japan.
The above appropriate class means a sufficient class of HAH license as follows;
-First-class Marketing Authorization Holders: Allowed to handle medical devices up to Specially Controlled Medical Devices
-Second-class Marketing Authorization Holders: Allowed to handle medical devices up to Controlled Medical Devices
-Third-class Marketing Authorization Holders: Allowed to handle general medical devices only
In order to obtain a MAH license, the company must be legally registered in Japan.
If your company is foreign and you intend to market in Japan, you must make a distribution agreement with a MAH license-holder company who become the applicant for approval. Alternatively, you can designate a MAH license-holder company as a DMAH.
A qualified MAH General Manager must be assigned as the responsible person in general charge of MAH-related affairs. The MAH General Manager for Medical Devices must have completed one of the following academic courses at university: Physics, Chemistry, Metallurgy, Electronics, Mechanical Engineering, Pharmaceutical Science, Medicine, Dental Science. Or, The person who completed specialized study to Physics, Chemistry, Metallurgy, Electronics, Mechanical Engineering, Pharmaceutical Science, Medicine, Dental Science in the vocational schools such as senior high schools except the university, the person must also have more than three years of work experience in quality control or post-marketing safety control in the field of medical devices. The MAH General Manager for Drug must be a pharmaceutical chemist.
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
Those who only do the packaging, labeling and storage in the manufacturing process, are required to get a license for "Manufacturer for packaging, labeling and storage.
In order to be licensed as a Manufacturer for Packaging, Labeling and Storage, one qualified personnel (Responsible Engineer) must be assigned and the regulations for buildings and facilities must be met.
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.
"NINSHO" is a certificate for a medical device. One certificate (NINSHO) covers only one model of a medical device. NINSHO is given by a Registered Certification Body to a Class II medical device.
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
In November, 2014, the Ministry of Health, Labour and Welfare revised the Pharmaceutical Affairs Law and enforced the “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” in order to ensure safe and prompt provision of pharmaceuticals, medical devices, etc. In this report, however, hereinafter referred to as “PAL” for the sake of convenience.
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).
An ordinance issued by the Ministry of Health, Labour and Welfare (MHLW) to set the QMS requirements.
The qualifications of the person responsible for quality control are set forth in the GQP guidelines.
The individual must have more than three years of work experience in the field of quality control or a similar field in the medical devices industry. He/she must not be involved in any sales activities.
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 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.
One is required to get a license for Medical Device Repairer in order to do the repair business
What is the difference between a MAH and a retailer?
Only one MAH can exist for each approval (certification), and that MAH company can import the products and carry out duties related to post-marketing surveillance. The products are distributed to retailers through the MAH (or DMAH).
This license must be held by those selling, leasing and/or transferring medical devices directly to end users. To obtain this license, one specially qualified personnel must be assigned as the Retail or Rental Business Manager.
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.
A qualified person responsible for post-marketing safety must be assigned, and the company must meet the GVP guidelines (GVP: Good Vigilance Practice, the Ministerial Ordinance on standards for post-marketing surveillance for drugs, quasi-drugs, cosmetics and medical devices).
The qualifications of the person responsible for post-marketing safety are set forth in the GVP guidelines, and vary depending on the MAH classification.
The individual must have more than three years of work experience in the field of safety management (collection of safety-related information, evaluation of product security, post-marketing safety management etc. ) He/she must not be involved in any sales activities.
"SHONIN" is an approval for medical device. One case of approval (SHONIN) covers one model of a medical device. SHONIN is given by the Japanese government to a Class III or IV 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.
"TODOKEDE" is an notification for medical device. One case of notification (TODOKEDE) covers one model of a medical device. TODOKEDE is given by the Japanese government to a Class I medical device.
|Risk class||Classification of medical device||Registration category|
|Class I||General medical devices||Notification (self-certification)|
|Class II||Designated controlled medical devices||Registered Certification Bodies (Third-parties) Certification or PMDA Approval|
|Class III||Controlled medical devices||PMDA Approval|
|Class IV||Specially controlled medical devices||PMDA 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|
|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|