Quick Guide to Aesthetic Medical Devices and Regulatory Compliance

What are Aesthetic Medical Devices? 

As per USFDA, “Aesthetic (cosmetic) devices are typically used to improve appearance. They may be regulated by FDA depending upon their intended use and whether they impact the structure or function of the body”. The availability of new and exciting aesthetic medical equipment worldwide has led to an increase in demand for medical aesthetic treatments in recent years. 

The advancement of high-tech aesthetic medical devices makes cosmetic treatments more effective and safer than previous treatments, resulting in a high demand for physicians, aestheticians, cosmetologists, and other skincare professionals. 

The medical aesthetics industry is developing a wide range of technologies, devices, processes, and systems around the world, including cosmetic lasers, infrared light, radiofrequency (RF) energy, and ultrasound technology. Cosmetic lasers are used in medical and beauty spas for dermatological purposes to help patients resolve wrinkles, skin resurfacing, cellulite reduction, pigmentation, hair removal, unwanted veins, skin conditions, fat reduction, body contouring, and other cosmetic issues. 

Aesthetic medical devices are based on the technologies like, Radiofrequency technology which is most popular and highly beneficial technology used   for facial wrinkle reduction, ultrasound technology, laser technology etc. 

What is Regulatory Compliance in Aesthetic Medical Devices?  

The changes in medical device regulations creating ambiguity among device manufacturers. New medical device regulations have widened the scope of classes of devices and other responsible factors of regulatory compliance. The regulations are reshaping and improving safety practices and guidelines. As medical device regulatory let’s take look of applicable regulatory compliance for these devices 

EUMDR compliance: 

Previously Europe had MDD framework which excluded cosmetics and aesthetics medical devices from its scope. But the current European Medical device regulations 2017/745(MDR) covers many types of these products.  Annex XVI of MDR grouped few of cosmetics and aesthetic products like dermal fillers, tattoo removal equipment, collagen implant, colored contact lenses and other products   need to be complaint with the New Regulations. So, to sell   Annex XVI products in Europe manufacturers need to be complaint with the requirements laid out in EUMDR and for the hazel free regulatory compliance our team can assist you.  

How can we help you in EUMDR Compliance for Aesthetic Medical Devices? 

The transition of MDD to MDR is confusing for some of manufacturers, our EUMDR specialist team can build up effective transition strategy for your range of medical devices. We help you in 

• CE mark certification 
• Creation and submission of technical file to notified bodies 
• Training and implementing the ISO13485 Quality Mangement system  
• Post market surveillance planning  
• Clinical Evalution reporting (CER) 

We assisted medical device manufacturers to obtain CE marking in Europe. we have the regulatory and quality experience to speed up your process and ensure compliance with MDR criteria. 

USFDA Regulatory Compliance for Cosmetics and Aesthetic Medical Devices: 

The aesthetic devices rejuvenate and tighten skin, smooth out or minimize wrinkles, and produce a more youthful appearance. the FDA and Health Canada have given their approval to these items. USFDA has two regulatory pathways which allow manufacturers to market their products in the USA. The first one is the FDA510(k) process which works by comparing the new device with already existing and FDA-cleared device and determines the two devices are substantially equivalent. Another pathway is PMA premarket Approval Process) which is mostly used for Class lll devices due to the higher risk. As an FDA510(k) consultant we assist manufacturers in their regulatory compliance process. For regulatory compliance with USFDA, you can easily contact us. 

Indian Import/Manufacturing License for Aesthetic Devices: 

The Indian market for aesthetic medical devices is showing a positive prospectus. The increasing use of aesthetic operations, new technologies, and the demand for procedures to enhance appearance are the main drivers of this business. To manufacture these devices in India device maker should register with CDSCO and get the manufacturing license. As a CDSCO manufacturing consultant, we provide end-to-end assistance to our clients. To import these aesthetic medical devices, one needs to register with CDSCO and should get a CDSCO import license. 

Cosmetic and aesthetic medical device companies must learn new regulatory and quality assurance paradigms, many new medical device technologies developed and they provide superior aesthetic benefits. Aesthetic medical devices and their manufacturing and regulatory compliance is a vast subject of discussion. to discuss more on Aesthetic medical devices contact to our experts or you can Whatsapp your requirements to us we will shortly answer your queries.