F108031 Wholesale of medical equipment, F208031 Retail of medical equipment
In accordance with the provisions of the Medical Device Management Law, it is an industry that operates medical device wholesale, medical device leasing and repair business. Its products include the items listed in the appendix of the Measures for the Classification and Grading of Medical Devices.
In accordance with the provisions of the Medical Device Management Law, the business of retailing medical devices, leasing and repairing medical devices. Its products include the items listed in the appendix of the Measures for the Classification and Grading of Medical Devices.
Simple process:
order | process | estimated days |
1 | Central Office of the Ministry of Economic Affairs (name pre-check) | 2~3 days (excluding holidays) |
2 | Taipei City Government Health Bureau 1 (Preparation Application) | 7 days (excluding holidays) |
3 | Taipei City Government (company establishment) | 1~2 weeks (excluding holidays) |
4 | Taipei City Government Health Bureau No. 2 (establishment and license) | 7 days (excluding holidays) |
5 | Internal Revenue Service (tax registration) | 2~3 weeks (excluding holidays) |
required materials:
Taipei City Government Health Bureau 1:
project | illustrate |
Service Content | To apply for medical equipment wholesale business and medical equipment retail business, an application should be made to the Health Bureau of each county (city) government. |
Items to be prepared | 1. application 2. Business premises address and equipment diagram 3. Photocopy of the front and back of the ID card of the person in charge 4. Photocopy of company name pre-check verification letter 5. A copy of the query form for land use zoning control and construction management regulations in business premises (need to comply with the regulations of the Construction Management Office and the Metropolitan Development Bureau) 6. company policy 7. Power of Attorney (not required for personal application) |
Precautions | 1. All photocopies need to be stamped with large and small stamps 2. Actual site survey by Taipei Municipal Health Bureau 3. Sales of medical equipment engaged in import or maintenance shall be registered as technicians |
Taipei City Government Health Bureau II:
project | illustrate |
Service Content | After obtaining the establishment permit of the medical equipment wholesale business and the medical equipment retail business, the company should complete the company registration and apply to the health bureau of each county (city) government for establishment and license. |
Items to be prepared | 1. application 2. Power of Attorney (not required for personal application) 3. Photocopy of the approval document of the Health Bureau 4. Photocopy of the Taipei City Government’s approval document and establishment registration form |
Precautions | 1. All photocopies need to be stamped with large and small stamps 2. Need to personally pick up 3. Fee NT 1,500 |
common problem:
Question one:
We are engaged in the sale of masks. Do we need to apply for a medical equipment wholesale and retail license application?
Response one:
If you sell masks, you need to confirm the nature of the masks
If the nature of the mask is "medical", it belongs to the scope of F108031 medical equipment wholesale business and F208031 medical equipment retail business
If the nature of the mask is "non-medical", it belongs to F199990 Other wholesale business and F299990 Other retail business
Question two:
We are engaged in the sale of cosmetics. Do we need to apply for a medical equipment wholesale and retail license application?
Response two:
If selling cosmetics, it falls within the category of F108040 Cosmetics Wholesale and F208040 Cosmetics Retail, and does not need to apply for a medical equipment wholesale and retail business license
Question three:
What kind of items do you need to apply for a medical device wholesale and retail license application for the sale of items?
Response three:
Sales of syringes, medical consumables, dental materials, gauze and bandages, prescription lenses and frames used for prescription lenses, contact lenses and their potions, tablets, etc., all need to apply for a medical equipment wholesale and retail license
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