Today, injection techniques of modern aesthetic medicine make it possible to solve many problems of patients. Hundreds of people who need their services turn to specialists every day.
It is important that the solution of any aesthetic problems is carried out by highly qualified specialists, without the risk of complications and side effects. During the procedures, the doctor uses special preparations that correct wrinkles, the contour of the face, its individual areas, etc.
Therefore, it is very important that these drugs are safe and approved at the official level. The material estet-portal.com will discuss the legalization of medicines in aesthetic medicine.
Evaluation and registration of medical devices
From July 1, 2017, a new period in the history of Ukraine began for the legalization of medical products that are sold on the market of aesthetic medicine and professional cosmetology. The Technical Regulations on Medical Devices (CMU Decree No. 753 of 02.10.2013) came into full force. The new procedure is called "Conformity assessment of medical devices" and it is fundamentally different from the previous procedure "Registration of medical devices", because. The new Technical Regulation is almost completely copied from the European Directive 93/42/EEC on medical devices (Directive 93/42/EEC).
The range of products for aesthetic medicine and professional cosmetology includes several categories of products that are classified as medical devices, according to the classification criteria Supplement 2 of Technical Regulation No. 753:
- Fillers that are injected into human tissues (fillers, biorevitalizants, etc.)
- Threads for tightening and reinforcing face and body tissues, incl. in needles and cannulas.
- Needles for injection procedures (revitalization, mesotherapy, etc.)
- Cannulas for filling, revitalization, liposuction, etc.
- Equipment and consumables for PRP therapy (centrifuges, test tubes, etc.)
To switch to the new "rules of the game" The Cabinet of Ministers of Ukraine issued Resolution No. 240 dated March 23, 2016, which defines the main points of such a transition:
- Import into the territory of Ukraine of medical devices under registration certificates of the Ministry of Health with an unlimited validity period is allowed until July 1, 2017. The sale of these products is allowed for 5 years from the date of import or until the expiration date of the product itself.
- Products put into circulation under the registration certificates of the Ministry of Health are not subject to market surveillance and are not subject to additional marking with a national conformity mark.
- It is not possible to extend the validity of the certificate of registration or make any changes to it.
List: legal trademarks and their manufacturers
The State Register of Medical Equipment and Medical Devices, posted on the website of the State LekSluzhby, currently operates only in the information mode. According to its data, the following trademarks of medical devices, which have a certificate of registration of the Ministry of Health with an unlimited validity period, may be present on the Ukrainian market:
|
Trademark |
Manufacturer |
Registration date |
Certificate number |
|
FILLERS |
|||
|
Amalian |
S&V Technologies AG |
30.12.2013 |
13470/2013 |
|
Aqualyx |
GHIMAS SpA, Italy |
12/14/2012 |
12204/2012 |
|
Auralya |
IRA Instituto Ricerche Applicate Srl, Italy |
27.06.2014 |
14013/2014 |
|
Beautelle |
IRA Instituto Ricerche Applicate Srl, Italy |
09.10.2013 |
13160/2013 |
|
Bellcontour |
Hyal Intertrade SA, Switzerland |
29.05.2014 |
13902/2014 |
|
Dermafill |
SBS-MED Infinity Cosmetics SAS, France |
13.03.2015 |
14619/2015 |
|
Dermaheal |
Caregen Corporation Ltd., Korea |
09/05/2012 |
11807/2012 |
|
Dr. Korman Laboratories |
Dr. Korman Laboratories LTD., Israel |
22.01.2014 |
13526/2014 |
|
Esthelis |
Anteis SA, Switzerland |
10/11/2012 |
11926/2012 |
|
FillerVit |
ITALFARMACIA SRL, Italy |
16.08.2013 |
12895/2013 |
|
Fortelis |
Anteis SA, Switzerland |
10/11/2012 |
11926/2012 |
|
Genial |
Xcelens SA, Switzerland |
12.06.2013 |
12743/2013 |
|
H&S |
YURIA-PHARM, Ukraine |
12.02.2015 |
13590/2014 |
|
Hyaliaphase |
Mastelli Srl, Italy |
02.07.2013 |
12816/2013 |
|
HyalStyle |
CROMA GmbH, Austria |
19.08.2014 |
14208/2014 |
|
Hyalual |
YURIA-PHARM, Ukraine |
14.02.2014 |
8726/2009 |
|
Hyaluronica |
VITAL Esthetique, Sarl., France |
22.01.2014 |
13537/2014 |
|
Idune |
Laboratoires GENEVRIER SA, France |
13.07.2012 |
11709/2012 |
|
Jalucomplex |
IRA Instituto Ricerche Applicate Srl, Italy |
27.06.2014 |
14013/2014 |
|
Jalupro |
Professional Dietetics Srl, Italy |
10/11/2012 |
11968/2012 |
|
Juvederm Hydrate |
ALLERGAN, France |
07.04.2015 |
9616/2010 |
|
Juvederm Ultra |
Allergan Industrie, SAS, France |
12/14/2012 |
12189/2012 |
|
Juvederm Ultra Smile |
Allergan Industrie, SAS, France |
12/14/2012 |
12189/2012 |
|
Juvederm Volbellat with lidocaine |
Allergan Industrie, SAS, France |
02.07.2013 |
12505/2013 |
|
Juvederm Volift |
ALLERGAN, France |
30.06.2015 |
14988/2015 |
|
Juvederm Volift with lidocaine |
Allergan Industrie, SAS, France |
02.07.2013 |
12505/2013 |
|
Juvederm Voluma |
Allergan Industrie, SAS, France |
12/14/2012 |
12189/2012 |
|
Juvederm Voluma with lidocaine |
Allergan Industrie, SAS, France |
28.02.2014 |
11679/2012 |
|
Meso – Xanthin F199 |
ABG LAB LLC, USA |
10/11/2012 |
11959/2012 |
|
MesoEye C71 |
MycoScience Inc., USA |
03.03.2015 |
14596/2015 |
|
Mesolis |
Anteis SA, Switzerland |
10/11/2012 |
11926/2012 |
|
MesoSculpt C71 |
MycoScience Inc., USA |
03.03.2015 |
14596/2015 |
|
Meso-Wharton P199 |
BNC KOREA, INC., Korea |
30.06.2015 |
15020/2015 |
|
M-HA 10 |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
M-HA 18 |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
Models |
Anteis SA, Switzerland |
10/11/2012 |
11926/2012 |
|
NCTF 135 |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
NCTF 135HA |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
NCTF 135 HA+ |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
Nucleospire |
Mezopharm, TOV, Russian Federation |
13.05.2015 |
14740/2015 |
|
Nucliaphase |
Mastelli Srl, Italy |
02.07.2013 |
12816/2013 |
|
Perfectha Derm |
OBVIELINE SAS, France |
10/11/2012 |
11951/2012 |
|
Pluryal Booster |
MD Skin Solutions Luxembourg |
09/04/2013 |
13045/2013 |
|
Pluryal Meso |
MD Skin Solutions Luxembourg |
13.05.2015 |
14722/2015 |
|
Predermal |
YURIA-PHARM, Ukraine |
27.06.2014 |
13351/2013 |
|
Princess |
CROMA GmbH, Austria |
09.10.2013 |
13144/2013 |
|
ReDexis |
Prollenium Medical Technologies Inc., Canada |
29.12.2014 |
14476/2014 |
|
Restylane |
Q-Med AB, Sweden |
05.12.2014 |
14444/2014 |
|
Revaness |
Prollenium Medical Technologies Inc., Canada |
29.12.2014 |
14476/2014 |
|
RevitaJal |
IRA Instituto Ricerche Applicate Srl, Italy |
30.06.2015 |
14981/2015 |
|
Revofil |
Caregen Co., Ltd., South Korea |
05.12.2014 |
14411/2014 |
|
SBS-MED Dermafill |
SBS-MED Infinity Cosmetics SAS, France |
08.04.2013 |
12573/2013 |
|
Sculptra |
Sanofi-Aventis S.p.A., Italy |
11/13/2013 |
13281/2013 |
|
Style |
Laboratoires VIVACY, France |
14.02.2014 |
13614/2014 |
|
Surgiderm |
ALLERGAN, France |
07.04.2015 |
5451/2006 |
|
Teosyal |
TEOXANE SA, Switzerland |
12.06.2015 |
14849/2015 |
|
Uma Jeunesse |
Cambridge Medical Aesthetics Ltd., UK |
09.11.2012 |
12078/2012 |
|
Viscoderm |
IBSA FARMACEUTICI ITALIA SrL, Italy |
08.04.2013 |
12608/2013 |
|
XELA |
Hyal Intertrade SA, Switzerland |
30.12.2013 |
13509/2013 |
|
X-HA Volume |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
X-HA3 |
Laboratoires Filorga SAS, France |
10/11/2012 |
11994/2012 |
|
THREADS FOR LIFT AND REINFORCEMENT |
|||
|
Happy Lift Revitalizing |
Assut Europe Spa, Italy |
07.11.2014 |
14372/2014 |
|
JBP V-Lift |
Feel Tech Co., Korea |
11/13/2013 |
13253/2013 |
|
Lead Fine Lift |
GRAND AESPIO INC., Korea |
15.03.2013 |
12524/2013 |
|
NEEDLE AND CANNULA |
|||
|
BD Microlance 3 |
Becton Dickinson SA, Spain |
09.11.2012 |
7398/2007 |
|
CSH |
TSK Laboratory, Japan |
14.02.2014 |
13610/2014 |
|
K-PACK II |
TERUMO EUROPE NV, Belgium |
09/04/2013 |
13035/2013 |
|
STERiGLIDE |
TSK Laboratory, Japan |
14.02.2014 |
13610/2014 |
|
PRP THERAPY EQUIPMENT AND CONSUMABLES |
|||
|
Plasmolifting |
Chengdu Rich Science Industry Co., China |
12/14/2012 |
12146/2012 |
|
Tropocells |
Estar Technologies Ltd., Israel |
30.12.2013 |
13492/2013 |
Now everyone will be able to check the available drug according to this table. It is the duty of every specialist to know which drug he is using for medical purposes!
Official information for estet-portal.com provided by the Ukrainian Scientific Institute of Certification represented by Mikhail Vakhrushev.
Share:
Add a comment