Medical Devices Development Support Association Just another WordPress weblog

2009/09/17

WHAT WE DO

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image market research

Market Research & Product Evaluation

We study the market size of similar products, market trends, information on the competition and future prospects. We also support the design of development and marketing strategies by studying evaluations of products developed by companies

Responding to Global Needs

We respond to the various needs of companies planning to develop medical devices overseas in places like China. These include market research, conducting tests and clinical trials, and acting as an agent for pharmaceutical applications.



 

image product development & validation testing

Non-Clinical Trials (Medical Device GLP = Good Laboratory Practice)

We support non-clinical trials in order to evaluate the safety and effectiveness of medical devices. We conduct tests that conformaccording to GLP in biological safety testing. We draft protocols focused on pharmaceutical approval from test design, procedures, sample selection and pharmaceutical approvaand so on.l.

Clinical Trials (Medical Device GCP = Good Clinical Practice)

When conducting clinical trials, one must study the purpose and design of the testing trial must be studied by looking at the science, ethics and trustworthiness. Additionally, according to the revised Pharmaceutical Affairs Law requires, the monitoring standards in medical device clinical trials have become as strict as that in pharmaceutical clinical trials.strict monitoring standards even for medical products related to medical devices. Our association gives total support for clinical trials based on medical device GCP, from planning and execution to drafting final reports.



 

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Pharmaceutical Approval Applications

We draft the required application forms for approval to produce and sell medical devices. Not only do we draft forms, we also provide pre-application consultations on subjects such as judging the suitability of overseas data for use in making applications.

Dealing with the Revised Pharmaceutical Affairs Law

We support business conforming to GQP and GVP enforced by the revised Pharmaceutical Affairs Law and GMP based on ISO 13485, and we also support the building of management systems that take into consideration a firm’s circumstances.

Applications for Insurance Coverage Qualification

The most important issue for the development of new medical devices is Category C insurance coverage. From the starNot only the application documents but also t, sophisticated actions on all fronts shouldmust be requiredtaken on all fronts for these documents, and we provide consultations on this for Category C insurance coverage qualification applications.



 

image sales & post-marketing study research

Sales Support

We introduce medical device sales professionals and advise on basic sales and marketing strategies. In addition, we also advise on import-related affairs and product pricing (setting an appropriate price).

Post-Marketing Studyies(Medical Device GPSP=Good Post-Marketing Study Practice)

Under the revised Pharmaceutical Affairs Law, the system has been reconstructed to place a higher level of importance on post-marketing safety measures, and information on product quality, effectiveness and safety is thoroughly collected. We support the execution of post-marketing studies and tests that conform to GPSP in order to ensure the trustworthiness of application materials for new inspections and re-evaluations.



 

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Overseas Expansion Support

We provide support from product exportation to market entry in overseas locations such as China. This includes the acquisition of pharmaceutical approval for medical devices and market research (market size, trends regarding similar products, etc) outside Japan, support from studying market entry to sales, and a wide range of advice from foreign business customs to the state of medical care in the target country.



 

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Support for Entering the Japanese Market from Abroad

We provide support for firms from other countries such as China when they enter the Japanese market. Our support includes the acquisition of approval for imported medical devices in Japan and provision of market data. We also engage in various consultations with Japanese companies that are considering importing and selling new medical devices from abroad.



 

image temporary staffing & translation services

Temporary Staffing Services

We dispatch temporary staff specialized in various fields. They include researchers, technicians, pharmaceutical business professionals and more.

Translation Services

We offer high-quality translation services by translators specialized in various fields.


 

Foreign Manufacturer Certification

Foreign Manufacturer Certification

To apply for the manufacturing and sale approval from the Japanese government for a medical device made abroad, the foreign manufacturer needs to get the Overseas Manufacturer Certificate from the Minister of Health and Labor of Japan.
MDSA provides services from legal document writing to acting for overseas manufacturers to clear approval affairs.


 

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Seminars & Training

We regularly hold practical lectures based on the personal professional experience of our speakers on indispensible subject areas for placing medical devices on the market that include application for pharmaceutical approval, clinical trials and understanding the Pharmaceutical Affairs Law. We also dispatch lecturers for in-house training seminars.

Seminar Texts Available for Purchase

We sell texts used in seminars and trainings.

Email Consultation Service

We answer even very simple questions and inquiries from anyone regarding medical devices. We will take your questions and consult with you on medical devices, even if you think “I can’t ask anyone something this so simple!” or “No matter who I ask, I don’t understand!”


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