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PMTA? ISO 9001? GMP 820? FCC? What does these certifications mean and what do they certificate?

2022-08-02 interests

PMTA (Premarket Tobacco Application)

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. After more than 2 years of project preparation and research, VOOPOO has formally submitted PMTA on August 27th, US time and passed the first round of review.

The products of VOOPOO have passed many certifications as well.

ISO 9001

Is the internationally recognized standard for Quality Management Systems (QMS). It is the most widely used QMS standard in the world, with over 1.1 million certificates issued to organizations in 178 countries.

ISO 9001 system helps organizers ensure that they meet customer’ and other stakeholders’ needs within statutory and regulatory requirements related to product or service. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.


The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act).

FDA officially requires the e-cigarette manufactures, which intend to sell their products online on Amazon and other e-commerce platforms, pass the GMP 820 quality certification. In the following market inspection, if the manufactures’ products or operations can not meet GMP 820 demand, FDA will give punishment on these manufactures.

TPD (Tobacco Products Directive)

It is the regulation and supervision of the process of product manufacture, selling and display (product design, package) of tobacco and tobacco related product like e-cigarette. Since 2016, e-cigarette will be supervised by Chapter 20 of TPD.


It is multilateral agreement to allow international certification of electrical and electronic products so that the certification allows worldwide market access.

FCC (Federal Communications Commission)

It provides certifications for wireless products, communication products and digital products. Only with FCC certification, can these products enter US market, proving the product safety of life and property.


It is the certification of safety of products, which is recognized as the “passport” of the manufactures entering Europe. The CE logo is the compulsive premise of product free flow in European market.

UL (Underwriter Laboratories Inc.)

It is the authoritative non-government and non-profit institution for product safety testing.  It adopts scientific testing methods to analyze and conclude the extent of harm of materials, equipment, products and constructions to life and property. It provides the certifications services of safety and management security, aiming at providing products with safe standards.


It is multilateral agreement to allow international certification of electrical and electronic products so that the certification allows worldwide market access.

Now, VOOPOO’ products have undergone UL, FCC, CE, TPD, CB and other product certification process. VOOPOO production bases are in line with ISO 9001 quality control system and GMP820 qualification requirements. With the PMTA standard of US FDA, the outstanding product quality provides world-wide users a better life experience.

Thanks for your reading and VOOPOO wish you have a nice vaping experience!

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