Today, given the oversaturation of the market with drugs for contouring, it is very important to comply with all points of the technical regulations for medical devices (including injectable fillers), approved by the Cabinet of Ministers of Ukraine No. 754 of 02.10.2013. cosmetic companies supplying preparations for contour plastics must necessarily pass the conformity assessment procedure for these products with the application of the national mark of conformity. The need for such procedures in the article estet-portal.com emphasizes the company ENA Betelgeiz – manufacturer of hyaluronic acid fillers.
- Certification of drugs – one of the main points of safety for doctors and patients
- Quality control of products for contour plastics
- Certified preparations for contouring ENA Betelgeiz
Certification of drugs – one of the main points of safety for doctors and patients
Yes, certification procedure for drugs in – a long and costly point in doing business, but it is fundamental to the policy of ENA Betelgeiz, as it represents one of the main points of doing a safe business, the safety of doctors and patients.
The company is the developer of its own exclusive line of cosmetic brand ENA Betelgeiz. The products of this line open the way to the beauty of each person, taking into account his individual habits and lifestyle. ENA Betelgeiz pushes the boundaries of what is possible and makes innovation accessible to everyone!
To ensure the high quality of ENA Betelgeiz fillers, the manufacturer strictly adheres to the international quality standards ISO 13485.
The company's products undergo strict production controls and comply with GMP standards. Using an exclusive production system with triple control quality, ENA Betelgeiz creates a unique final product.
Quality control of preparations for contouring
Today, a huge list of drugs for contouring in Ukraine should, to some extent, "force" our respected doctors to be more selective in their work with these products. At the same time, representatives of companies in the aesthetic industry must maintain strict control over imported products.
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Each country has its own authorities responsible for the quality and safety of medical devices on the market. Everyone is well aware of such structures as the FDA (USA), MHRA (Great Britain), as well as certificates of conformity issued by such regulatory bodies (FDA, CE, UA.TR.XXX). Certification is one of the guaranteed components of product safety.
As a rule, the pursuit of a cheap and illegal product – this is a 100% way to a huge risk of complications, loss of clients and business reputation of the doctor.
One of the steps in the safety review of a product by regulatory authorities is product quality control. A filler that has passed such a test, in addition to safety, guarantees the user the declared quality and long-term aesthetic result.
According to the technical regulation No. 754 of 2.10.2013 of the Cabinet of Ministers of Ukraine, preparations for soft tissue augmentation are classified as implantable medical devices, referred to as medical risk class III devices.
ENA Betelgeiz certified products for contouring
ENA Betelgeiz has certified nine products to date. These are fillers based on hyaluronic acid with and without lidocaine:
1) ENA Betelgeiz Soft;
2) ENA Betelgeiz Mild;
3) ENA Betelgeiz Hard;
4) ENA Betelgeiz Lips;
5) ENA Betelgeiz Soft with lidocaine;
6) ENA Betelgeiz Mild with lidocaine;
7) ENA Betelgeiz Hard with lidocaine;
8) ENA Betelgeiz Ultra with lidocaine;
9) ENA Betelgeiz Lips with lidocaine.
The packages of each product are marked with:
- manufacturer;
- authorized representative of the manufacturer in Ukraine;
- national mark of compliance with technical regulations;
- code of the accredited organization that issued the certificate of conformity.
Unfortunately, at the moment there is no unified register of certified medical devices in Ukraine, but all information about product certification can be found on the official websites of each conformity assessment body. In the case of ENA Betelgeiz , information about the validity of the certificate can be found by following the link that is indicated on the certificate itself.
ENA Betelgeiz – we create perfection!
ENA Betelgeiz assures that it will keep a strict control over the safety of its products, regardless of any subjective reasons, and guarantees all the necessary documentation for the safety of doctors and patients !
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