Medical equipment item manual
Updated: July 2024, 3
Once the general medical equipment market is established, the demand will be determined by the medical equipment itself, and the implementation will be handled accordingly.
Approval of the different categories of medical equipment, approval and approval of three different types of equipment, and the approval of the different types of equipment and equipment.
If you are looking for new medical equipment, there are many different types of medical equipment, and you can apply for approval to meet the demand.
| 类别 | Application form | application mechanism |
| General medical equipment (Ⅰ) | Manufacturing plan | Medical equipment assembly (PMDA) |
| Management medical equipment (Class II) | Application for manufacturing license | Third party authentication mechanism Or Medical equipment assembly (PMDA) |
| Highly controlled medical equipment (III/IV categories) | Application for manufacturing approval | Third party authentication mechanism Or Medical equipment assembly (PMDA) |
Medical equipment and other application instructions
Is it a medical equipment assembly (PMDA)?
Independent Administrative Institution Pharmaceuticals and Medical Devices Agency (PMDA) established National Institute of Medical Products, Food, and Medical Devices Research Center, Pharmaceuticals and Medical Devices Agency (PMDA) On April 2004, 4, an independent administrative organization was established for the Independent Administrative Agency Medical Equipment and Medical Equipment Integration Act, and approval of damaged medical equipment was approved.
In terms of the medical equipment field, we have accepted the offer for medical equipment manufacturing in category III, category IV medical equipment manufacturing, and acceptance of proposals for medical equipment manufacturing in category I, as well as foreign manufacturing commercial orders.
Is this a third party certification mechanism?
At the time of production of highly managed medical equipment as specified by the Minister of Health, Labor and Welfare, the Minister of Health, Labor and Welfare can obtain third-party approval for each item, and obtain medical equipment approval or approval.
Right now, 10 machines have been accepted and certified.
| Notebook | Name | Address | Phone Number |
| No. AA | TÜV SÜD Japan Ltd. | 4th floor, Building 33, Sumitomo Fudosan Nishi-Shinjuku Building, 4-4-8 Nishi-Shinjuku, Shinjuku-ku, Tokyo | 03-3372-4282 |
| No. AB | TÜV Rheinland Japan Ltd. | Shin-Yokohama 3-19-5, Kohoku-ku, Yokohama, Kanagawa | 045-914-3888 |
| No. AC | DQS Japan Inc. | 2th floor, PMO Nishi-Shimbashi, No. 9, 1-7 Nishi-Shimbashi, Minato-ku, Tokyo | 03-5521-1183 |
| AD issue | BSI Group Japan Ltd. | 2th floor, Aoyama Building, 12-28-5 Kita-Aoyama, Minato-ku, Tokyo | 03-6890-1177 |
| No. AF | SGS Japan Inc. | Yokohama Business Park North Square 134, 1 Kobecho, Hodogaya-ku, Yokohama City | 045-330-5010 |
| No. AG | Cosmos Corporation | 3571-2 Onogi, Watarai-cho, Watarai-gun, Mie Prefecture | 0598-30-5011 |
| No. AH | Japan Quality Assurance Agency (General Merchandise Corporation) | 1-25 Kanda Suda-cho, Chiyoda-ku, Tokyo | 042-679-0127 |
| No. AI | Nanotec Spindler Co., Ltd. | Nano Techno Plaza, 572-61 Juyo XNUMX, Kashiwa City, Chiba Prefecture | 04-7135-8810 |
| No. AK | Electric Safety Environment Research Institute (General Merchandise Corporation) | 5-14-12 Yoyogi, Shibuya-ku, Tokyo | 03-3466-6660 |
| AL issue | Medical equipment center (public goods corporation) | NKD Building, 3-42-6 Hongo, Bunkyo-ku, Tokyo | 03-3813-8703 |
Guanyu medical equipment items 
