1. Category I - no medical device license required

The first category of medical devices are medical devices with low risk and whose safety and effectiveness can be ensured by routine management, such as surgeries. Knives, surgical scissors, manual hospital beds, medical ice packs, cooling patches, etc., their products and production activities are subject to registration management by the local districted municipal food and drug regulatory authorities. All business activities are liberalized, and neither permission nor registration is required. All you need to do is obtain a business license issued by the industrial and commercial department.

2. Category II - Medical device business registration handled by the Municipal Food and Drug Administration

Category II medical devices have moderate risks and require strict control and management to ensure their safety and effectiveness. Medical devices, such as band-aids, condoms, thermometers, sphygmomanometers, oxygen concentrators, nebulizers, etc. that are common in our daily lives, their products and production activities are licensed and managed by the provincial food and drug regulatory authorities, which are issued to the "Medical "Device Registration Certificate" and "Medical Device Production License". Business activities are subject to registration management by the districted municipal food and drug regulatory authorities;

3. Category III - the State Food and Drug Administration applies for a medical device license

Category III medical devices They are medical devices that carry high risks and require special measures to be strictly controlled and managed to ensure their safety and effectiveness, such as common infusion sets, syringes, intravenous indwelling needles, cardiac stents, ventilators, CT, MRI, etc. Products and production and business activities are subject to licensing management by the State Administration of Industry and Commerce, provincial food and drug regulatory authorities, and districted municipal food and drug regulatory authorities, which issue "Medical Device Registration Certificate", "Medical Device Production License", and "Medical Device Production License" respectively. Business License".

Companies that operate medical device products need to apply for a "Medical Device Operating Enterprise License" from the local Food and Drug Administration

1. Materials required for medical device company registration

1. Company name and business scope, registered capital and shareholder contribution ratio, identification certificates of shareholders;

2. Medical device product registration certificate, production enterprise license, business license and authorization letter;

3. Quality management documents, etc.;

4. Certificates, identity certificates and resumes of more than 3 medical majors or related professionals;

2. Medical device companies Registration process

1. Go to the Industrial and Commercial Bureau to apply for the "Notice of Pre-approval of Enterprise Name";

2. Open a capital verification account, shareholders contribute capital, and the accounting firm issues a capital verification report;

3. Apply for a business license

4. Engrav a seal;

5. Apply for an organization code certificate;

6. Apply for a tax registration certificate;

7. Submit online application materials on the website of the local Food and Drug Administration;

8. After the online materials are reviewed and approved, the Food and Drug Administration will make an appointment and inspect the business site;

9. Submit written application materials, and issue a "Medical Device Business Enterprise License" after review and approval;

3. Preferential tax policies for medical device companies

1. Business tax: financial refund 35 of the actual tax paid.

2. Value-added tax: The finance will refund 7% of the actual tax paid.

3. Corporate income tax: The fiscal refund will be 12% of the actual tax paid.

The Finance Bureau will directly transfer enterprise support funds to the company's account every quarter.

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