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Aesthetic Medical Devices and Regulatory Compliance – An Overview

calendar15 Mar, 2023
timeReading Time: 5 Minutes
Aesthetic Medical Devices and Regulatory Compliance - An Overview

You might utilize aesthetic (cosmetic) devices to help get the desired result. However, there are hazards associated with using any device, even cosmetic devices, and a procedure may not always give you the results you want. The effects may also only last temporarily. Depending on their intended use and if they affect the structure or function of the body, aesthetic devices may be subject to FDA regulation. Talk to your healthcare practitioner about the advantages and disadvantages of aesthetic devices and whether you are a candidate for the procedure if you are thinking about any kind of aesthetic surgery. It’s critical to comprehend both the advantages and risks completely. You might also want to enquire about the education and experience of your healthcare professional with the procedure. Scroll down to check more information regarding Asthetic Medical Devices and regulatory compliance.

What are Aesthetic Medical Devices?

“Aesthetic (cosmetic) devices are primarily used to improve appearance,” according to USFDA. Depending on their intended use and if they affect the structure or function of the body, they may be subject to FDA regulation. The demand for medical aesthetic treatments has grown recently as a result of the accessibility of innovative and interesting aesthetic medical technology on a global scale.

There is a significant need for doctors, aestheticians, cosmetologists, and other skin care specialists as a result of the development of high-tech aesthetic medical devices that make cosmetic treatments safer and more efficient than prior treatments.

Cosmetic lasers, infrared light, radiofrequency (RF) energy, and ultrasound technology are just a few of the many innovations being developed by the medical aesthetics sector globally. In medical and spa settings, cosmetic lasers are used for dermatological procedures to treat patients’ wrinkles, cellulite, pigmentation, hair removal, undesirable veins, skin problems, fat reduction, and other cosmetic disorders.

The technologies utilized in aesthetic medical devices include laser technology, ultrasound technology, and radiofrequency technology-the most well-known and effective technology for reducing facial wrinkles.

New Changes Brought Under MDR

Certain manufacturers of products used in the medical sector have expressed worry about the changes brought about by the Medical Device Regulation, or Regulation 2017/745, which was just adopted. The definition of a “medical device” was expanded by the new medical device legislation, which was introduced on April 5, 2017. Many manufacturers are now wondering what effects this would have on their products or devices and how it will affect the compliance process.

The legislation has expanded the definition of what we consider to be a medical device to include so-called “aesthetic products/devices” in an effort to rethink and improve fundamental health and safety standards and recommendations. Any product or device “without an intended medical purpose” that is still utilized in the same way as or has usage characteristics/risks that are comparable to those of a medical device already covered by the prior regulation is described as an aesthetic product or device.

The main repercussions for manufacturers of cosmetic products will be the necessity to fully comply with MDR 2017/745 for every product affected by the new rule, including adding (unless already installed) the necessary standard of notification and post-market surveillance methods. The modifications made were intended to guarantee a higher degree of consumer safety as well as a higher level of manufacturer transparency and compliance with EU standards.

The rule will make sure that all types of gadgets live up to their claims and are appropriate for their intended use under normal operating conditions without endangering the user’s safety. The following are a few instances of devices to which the rule will apply to:

  • Contact lenses,
  • Surgically invasive products intended to enter the human body,
  • Facial dermal fillers,
  • Liposuction tools,
  • Lasers for skin resurfacing,
  • Tattoo removal, or hair removal,
  • Tools for electromagnetic brain stimulation, and
  • Products or cleaning or sterilizing equipment used in the medical field are examples of restricted items.

Other changes made by 2017/745 that will have an impact on manufacturers include the mandate that products be submitted to the EUDAMED database, a repository of data on all medical devices sold in the EU, and the implementation of the Unique Device Identification (UDI) system, which requires UDIs to be attached to each product or device’s packaging.

In order to ensure that best practices for post-market surveillance are preserved, it also requires manufacturers to set up adequate incident reporting, risk management, and customer complaint mechanisms.

What Is Regulatory Compliance In Aesthetic Medical Devices?    

Device manufacturers are confused as a result of the changes to medical device laws. The scope of device classes and other key elements of regulatory compliance has been expanded by new medical device laws. The rules are redefining and enhancing safety procedures and standards. Let’s look at the applicable regulatory compliance for these devices as it relates to medical device regulation.

  • EUMDR Compliance

In the past, Europe had an MDD framework, but it did not cover cosmetic and aesthetic medical devices. However, many of these products are covered under the current European Medical Device Regulations 2017/745(MDR). A few cosmetic and aesthetic products, including dermal fillers, tattoo removal tools, collagen implants, colored contact lenses, and other products, are listed in Annex XVI of the MDR and must comply with the New Rules. So, manufacturers must comply with the standards outlined in EUMDR in order to market Annex XVI items in Europe, and for hazel-free regulatory compliance, our team can help. 

  • USFDA Regulatory Compliance For Cosmetics And Aesthetic Medical Devices 

The skin is rejuvenated and tightened by aesthetic devices, which also diminish or eliminate wrinkles and give users a more youthful appearance. The FDA and Health Canada have approved these products. Manufacturers can advertise their products in the USA through one of two regulatory channels provided by the USFDA. The first one is the FDA 510(k) process, which compares a novel device to one that has already received FDA clearance and decides that the two are substantially identical. Due to the higher risk, Class ll products are typically approved through the PMA premarket Approval Procedure, which is another route. 

Indian Import/Manufacturing License for Aesthetic Devices

The outlook for the Indian market for cosmetic medical devices is promising. The key factors driving this industry are the rising demand for procedures to improve appearance, new technologies, and the expanding usage of aesthetic procedures. Device manufacturers must register with CDSCO[1] and obtain a manufacturing licence in order to produce these products in India.

Many new medical device technologies have been developed, and they offer improved aesthetic benefits. Cosmetic and aesthetic medical device companies must acquire new regulatory and quality assurance paradigms.

Products For Aesthetic and Cosmetic Use That Is Subject To MDR Criteria

The following cosmetic and aesthetic products are listed in Annex XVI of the MDR as being subject to the new Regulation:

  • Collagen implants,
  • Colored contact lenses,
  • Dermal fillers,
  • Dolid body contour-modifying implants,
  • Laser and intense pulsed light (IPL) hair removal tools, 
  • Skin resurfacing tools, and
  • Tattoo removal tools.

In order to sell their products in Europe, manufacturers of cosmetic and aesthetic products must get and maintain CE Marking. MDR compliance.

Conclusion

The EU Regulation 2017/745, which was established with the primary goal of preserving the public’s health, has numerous significant ramifications for goods used for non-medical purposes. Cosmetic lenses, aesthetic implants, subcutaneous fillers, lifting threads, equipment for liposuction and lipolysis, lasers, and other electronic devices with aesthetic uses are among the products on this list. Manufacturers must begin to think about their MDR requirements as soon as possible. Ensure strict safety standards, this will involve maintaining thorough technical documentation backed by testing and clinical data. Additionally, they will need to set up Quality Management and Risk Management Systems while continuously monitoring customer input.

Also Read:
Four Prominent Benefits Of Drug License That You Must Know
Importance Of Medical Device Compliance In India – An Overview
A Step By Step Guide For Registration Process For Medical Devices In India

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