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WHAT IS PMTA

WHAT IS PMTA

PMTA (Premarket Tobacco Application) means that after February 15, 2007, the legal listing of any new tobacco product requires FDA approval. The agency needs to consider whether this product is beneficial to public health.

Our Specialities

After project preparation and research, WOOMI submitted a PMTA to the FDA before October 3, 2021.

Our Specialities

Step 1

Project Team Established
Our Specialities

Step 2

Market Research
Our Specialities

Step 3

Product Development
Our Specialities

Step 4

Comprehensive Testing
Our Specialities

Step 5

Data Preparation
Our Specialities

Step 6

Submit Application

Our Product Testing

Our product testing conducts scientific research and analysis in product analysis and manufacturing research, non-clinical research, clinical human research and other compliance fields.

Our Product Testing
01

Product Safety Guarantee

The HPHCs test is designed to analyze product components under high-intensity and non-high-intensity use conditions, including HPHCs and other toxicological analysis, to evaluate the toxicological and pharmacological properties of the product in detail, to ensure that the product components are harmless, and to ensure user safety.
02

Material Safety Guarantee

In the process of supplier selection and raw material control, clear PMTA requirements on extracts and extracts to ensure supplier and raw material compliance. Meanwhile, the traceability of the whole process is realized, and the responsibility of each link is clarified to ensure the product quality and the safety of raw materials.
03

Electrical Safety Guarantee

ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices, is recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products. The development of UL 8139 also addresses specific fire safety concerns raised by North American fire officials.

Digital Factory

Provide world-class quality and safe products
WOOMI digital factory established ISO9001:2015 and GMP820 quality management system, and invested millions of dollars to create a higher standard manufacturing environment and quality management system, which fully guarantee the standardized and intelligent management of design and development, product raw materials, production and manufacturing, product testing, quality control and other processes, and provide world-class quality experience.
CLASS 100,000 DUST-FREE CLEAN WORKSHOP CLASS 100,000 DUST-FREE CLEAN WORKSHOP02
01

CLASS 100,000 DUST-FREE CLEAN WORKSHOP

2023-07-16
Which meets the requirements of ISO14644-2015 (International Standard for clean rooms and related control environment) and GB 50547-2019 (design standard for clean rooms in pharmaceutical industry).
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ACE HOTEL Mes Intelligent Control System
01

Mes Intelligent Control System

2023-07-16
MES (Manufacturing Execution System) is a collaborative supply chain management service system covering supplier management, order management, planning management, production management and delivery management.
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ACE HOTEL Industry-Leading Automated
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Industry-Leading Automated

2023-07-16
WOOMI digital factory introduces modern , simplify assembly procedures to improve production efficiency, and create a dedicated laboratory, strict product quality testing, and ensure product safety and reliability.
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ACE HOTEL Full Process Traceable Quality
01

Full Process Traceable Quality

2023-07-16
8 core processes are set up for quality control, and the whole process can be traceable through MES system management.
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Commitment To Social Responsibility

WOOMI has always put product safety at the top of its list, and is committed to taking responsibility for the industry, users and society. And WOOMI has invested millions of dollars to prepare PMTA and will formally submit PMTA application to FDA before October 3, 2021.

PMTA is not an obstacle to the atomization industry, but a new starting point. WOOMI will continue to uphold the spirit of innovation, actively assume the responsibility of guardian of young adults, protect the health and safety of global consumer users, and promote orderly and good development of the industry. WOOMI will lead the market development with product and technology innovation in PMTA standards, and bring better life experience to global users.