Hello, this is Support Administrative Scrivener Corporation. A vaccine for the new coronavirus has been approved, and the path to vaccination is now in sight. One of the hot topics right now is syringes. We've been receiving an increasing number of inquiries, so we'll provide an overview on this page.
Recommended for those who fall under the following categories
・We can supply syringes domestically! I want to complete the procedure quickly and deliver it quickly! For those who think that
・Although we do not have experience handling syringes, we can technically become a supplier! Those who say
・You can import syringes from overseas and supply them domestically! Those who say
A medical device called a syringe
The syringe is a class I or II medical device. Since it is a medical device, there are regulations regarding import, sales, and distribution. Compared to Class III and Class IV, which require approval, the procedures leading up to sales are less difficult.
Class I
Class II
Class III
Class IV
Product procedures
notification
Authentication/Authorization
Approval
Domestic manufacturing factory
Overseas manufacturing factory
Domestic storage factory
Medical equipment
Manufacturing industry registration
Medical equipment
Manufacturing industry registration
Medical equipment
Manufacturing industry registration
Manufacturer
Type XNUMX
Medical equipment
Manufacturing and sales license
Type XNUMX
Medical equipment
Manufacturing and sales license
First class
Medical equipment
Manufacturing and sales license
wholesale store
retail store
Must not
Medical equipment sales industry
notification
(Permitted if specified maintenance management applies)
Medical equipment sales industry
Authorization
Verification and procedures regarding handling of syringes
If you are considering handling syringes from now on, Verify that the product has guaranteed quality, effectiveness, and safety as a medical device, Product formalities must be completed before sale.
In addition, before this product procedure, please check with the manufacturing factory, importing distributor, or storage factory. It is also important to note that a medical device manufacturing and sales business license and medical device manufacturing business registration are required.
Even for syringes manufactured overseas, it is necessary to complete these procedures before importing them.
A certified administrative scrivener will assist you with the procedures.
Unlike miscellaneous goods, medical devices that affect the human body face regulatory hurdles.
For medical device manufacturing and sales business license and manufacturing industry registration, It is necessary to secure a responsible person with academic background and experience in quality assurance work, etc. It is necessary to prepare a management system called Quality Management System, which is equivalent to ISO. To be honest, the system is quite difficult for new entrants. However, experienced professionals like us can provide you with excellent support throughout the process.
Furthermore, for those who find it difficult to obtain licenses and permits, We also arrange import agency services through licensed and authorized companies.
