Does kn95 need a medical device license

First, whether you need a license to sell ___ hoods depends on the type of ___ hood. Medical __ hoods require qualification, __ medical __ hoods do not.

9_2019_issued_the_decision_on_adjusting_the_industrial_product_production_license_management_recording_strengthening_the_supervision_after_the_event_, abolished the _industrial_product_production_license_management_of_special_labor_protection_products, so the enterprise _producing_medical__masks no longer need to apply for an _industrial_product_production_license_(QS certification)

So, in terms of the current regulations, the enterprise _producing_medical _ hood, in addition to meet the _ general _ industry enterprises in the market quasi _ conditions, in fact, does not need special qualification license, which _ point is different from _ production of medical _ hood.

_, the company _ production _ medical _ cover what procedures are required?

1, _ business change registration

Enterprises switching to _ medical _ particulate protection _ hood _ production, need to be in accordance with the provisions of Article ___ of the Companies Act on the change in the scope of business into the _ business change registration, to increase the "special labor protection _ products manufacturing" (specific to the Market Supervision Authority shall prevail) the scope of business.

2, the required materials: (1) application for registration of changes in the record

(2) amended articles of incorporation

(3) on the amendment of the articles of association of the resolution

(4) the original business license.

Enterprises can check with the local market supervision authority to confirm the existence of the relevant emergency channel to facilitate enterprises in the epidemic protection period to speed up the registration of such _ business changes, many cities can be through the _ network of the same day to close.

In summary, the qualifications required to sell masks need to be based on the category of masks you sell, medical masks require special qualifications license, it is recommended to determine the category of masks sold to buy in accordance with the provisions of the Department of the preparation of the required qualifications.

Legal basis:; According to the "Supervision and Administration of Medical Devices Regulations" Article 3 _, engaged in the operation of class _ medical devices, by the business enterprise to the location of the district municipal government _ drug supervision and management department for the record and submit it to comply with the requirements of the conditions required to engage in the operation of medical equipment related information. If you need to sell on the _, but also in accordance with the "supervision and management of medical equipment _ network sales approach" provisions into the _ network transactions for the record.