Laser certification
1. Application Form
Application form: including company information, product information, etc
2. Product File/Technology Specification
Product documents/technical materials: mainly including preparing detailed manuals/sales manuals, installation manuals, maintenance manuals, etc; Product assembly drawings; And product technical information, whether there are laser protection measures and a description of their working principles.
3. Label
Labels: English labels that comply with regulations, including warning labels, product labels, compliance certification labels (such as Complaints with 21 CFR 1040.10&1040.11), and exit labeling labels, etc.
4. Laser Information
Laser device information: Type of laser generator, medium, laser path diagram, laser parameters, laser device qualification certificate/test record (if purchased from other manufacturers, information of the manufacturer, laser device parameters/datasheet or manual, and whether the laser device has FDA certification/FDA number are required).
5. Calibration Report of Power Meter
Annual metrological verification certificate and report of optical power meter.
6. Quality Control System
Quality control documents: mainly including internal quality control flow chart, inspection procedures, quality control specifications/control of design modifications; Production line sampling form, incoming material inspection form, finished product inspection form, internal inspection report, etc. (including samples of the form).
7. US Agent/Importer
US agent and US importer information: including full contact name, phone/fax/email, detailed US address/postal code, and company name; And the U.S. Agent Proxy Authorization Agreement.
Application process
Enterprise registration
Enterprise Registration Application Form
FDA confirms and releases the enterprise serial number;
1.2. Product Registration
Medical device products are divided into three categories based on their level of safety risk:
a) Class 1 medical device listing control
Category 2 market access recognition (i.e. 510 (K) recognition)
c) Approval before entering the market for Class 3 PMA
1.2.2 Entrusted agency
FDA Registration and Notification Entrustment Agreement (signed by the legal representative and stamped with the company seal)
1.2.3 Provide information
Enterprise Legal Person Business License
Certificate of Public Institution Legal Person Code, Registration Certificate of Association Legal Person, etc. (copy stamped with company seal)
a) Qualification certificate or production license certificate within the validity period (copy stamped with company seal)
b) FDA Registration Application Form (one in Chinese and one in English, stamped with the company seal)
c) Other documents required to be submitted by the FDA (if any).
Introduction to the company (establishment time, economic performance, technical strength, main production varieties and their performance, asset status).
1.3 Payment
Registration and listing are free of charge;
510 (K), PMA needs to pay according to the fee standards published online by the FDA.
Register
After charging, FDA will complete registration within 60 working days;
The FDA website announces the registration status, and the FDA of 510 (K) and PMA will send an approval letter for admission.