Acquisition of certification

Updated: July 2024, 3

This is the certification

The certification is for commercial purposes (purchasing or giving orders to others, etc.), and is for personal use or for medical purposes, as well as for medical equipment, etc., which have not yet been approved in Japan. A must-have certification book.

Obtained approval from the Ministry of Health and Welfare regarding demand requirements.

We will provide you with support and support for your application.

demand record form

① Personal user's oral expression

 When a certain amount of medical equipment is introduced in Japan, the demand for medical equipment will be confirmed at a certain time.

②Professional conditions for medical practitioners, etc.

 At the time of basic legal review and approval, etc., we proceed with examination research attached to the production (excluding floor examination), internal records of the production company (determined by the developer, goods for the purpose of product development, etc. for non-development market purposes, etc.) (Extremely exempt items for third-party division) Under the circumstances of the medical and mechanical conditions, we will provide the necessary information at the appropriate time. However, there is a limit to the operator's ability to proceed with the examination, treatment, etc.
As a result, if there are many different medical doctors in the same medical facility, each medical doctor may be required to produce the necessary products, and the general merchandise production may be carried out separately.

③Using the test on the floor, and the emotional state of the mouth

The following information is clear and the time demand is shown.

・Enterprises (commissioners of floor exams): self-produced, self-conducted, and the quality of the floor exams.

・The company is responsible for verifying the quality of medical products, etc. (hereinafter referred to as "certifications, etc."), as required by the company in order to confirm the quality of the product. The person who commissioned the test on the table Emotional form.

・Medical doctor or medical doctor's self-directed practice, self-made subject, practice, and the quality of the examination.

・As a result, the design of the medical equipment, etc. that the company must carry out, such as the identification of medical products, etc., is the subject matter of the medical doctor or the medical practitioner who is responsible for the examination of the product and the production of the product.

・Medical products that have not been obtained and approved for use in the future (excluding medical products that have not been obtained and approved for use) 、Because the company has to read the testimonials, etc., after the company runs its own operations, the situation is that of a family business (the person who commissioned the test).

Excludes information from the PMDA's test guide.

4Experimental research, etc.

The following information is clear and the time demand is shown.

・Product information for corporations (companies, etc.), research institutions, universities, etc. for examination purposes, oral products, medical instruments, non-medical products, chemical products, in vitro diagnostic products, regenerative medicine equipment, etc.

・Products of corporations (companies, etc.), research facilities, universities, etc., medical equipment, non-vehicle products, chemical products, in vitro diagnostic equipment, regenerative medicine equipment, etc., internal products, and operational information.

・Corporations (companies, etc.), research institutions, universities, etc., whose purpose of research is oral poisonous substances or toxicological conditions.

・As a result of the research organization, researchers affiliated with universities, etc., will conduct the research for the purpose of conducting oral poisonous substances or toxic substances.

⑤Using the exhibition and its appearance

 Attending academic conferences, public institutions, etc., conducting main or supporting exhibitions, etc., for academic research progress, exhibitions, scientific and technological fields, industry promotion, etc. purposes, exhibition medical equipment, etc., under the circumstances of the current situation, providing information on demand at any time.

⑥ Product appearance derived from original production and use of proprietary raw materials

Licensed medical equipment, approval, approval, etc. are compatible with each other, and we are familiar with the system.

We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc.

Medical equipment has a high level of industry, and its capabilities are perfect, as well as small administrative staff.

Our teams are present in all prefectures across the country. You must receive additional information from our system.