Comparison of medical devices:

USA:
The Food and Drug Administration regulates food, drugs, medical
devices, biologics and radiation emitting products in the USA.
Regulation of medical devices is supervised by the Centre for Devices
and Radiological Health. Medical devices are controlled under the
Federal Food Drug and Cosmetic Act. Before any medical device can be
marketed in the USA a marketing application must be acquiesced to the
FDA and permission attained. This practice is known as establishing
registration. Information must be acquiesced electronically and contains
a facts of the developed and supply site together with a list of the
medical devices marketed. The USA uses a threat-based arrangement
for medical devices which taking into account the planned use of the
product. The FDA has recognized a classification database where
general types of devices are gathered into 16 panels. Each panel is then
divided into more devices allocated to one of the three classification
classes. Class I is Low that present insignificant potential for harm to the
user. The types of devices are Tongue depressors, arm sling and hand
held surgical instrument examination gloves used in USA medical health
care system and the regulatory necessities are General controls.
Russia:
The registration and rules of medical devices in Russia is difficult and
includes a number of dissimilar regulatory authorities. Federal Service
on Observation in Healthcare and Social Development is the competent
authority and is answerable for registration clinical safety and
productivity of all medical devices. Federal Agency for Technical Rules
and Metrology makes assured that all medical devices encounter
recognized Russian standards. Russia uses a risk centered arrangement
structure for medical devices with four classes where class 1 is the
lowest and class 3 is the highest level of threat. Medical devices want a
GOST-R quality certificate and Hygiene Certificate previously they can
be imported for performance analysis.
China:
China is a member of AHWP and APEC. State Food and Drug
Administration a part of the Ministry of Health is answerable for the
regulation of both inside manufactured and imported medical devices.
The SFDA regulations monitor the USA FDA model. Medical devices are
classified into three classes I, II and III according to risk, with class I
being the lowest and class III the highest level of threat. The regulations
are difficult and require manufacturers to observe with a amount of
local and international standards. In addition to SFDA agreement of
seven categories of medical device those China Compulsory
Certification want. These include medical X-ray equipment,
hemodialysis apparatus, hollow fiber dialysers, extra-corporeal blood
circuits for blood purification apparatus, electrocardiographs,
implantable cardiac pacemakers, and artificial heart-lung machines.
Products produced in China can carry the China Export sign which is not
a registered trademark. Post -market observation of medical devices in
China is still in development. Observation for medical devices is
currently limited to adverse event reporting and recall, alongside
limited review of manufacturers by the SFDA.
India:
India is a supporter of AHWP. The regulation of medical devices in India
is currently managed by the Central Drug Standards Control
Organization which is part of the Ministry of Health and Family
Wellbeing. Medical devices are defined as drugs and regulated under
the Drug and Cosmetics Act and the Drugs and Cosmetic Rules. Under
the current system only imported implantable devices are diagnostic
kits and sterile devices require registration. The devices are classified as
moreover life saving medical equipment or non life-saving medical
equipment. Medical devices not defined as drugs only require an
import license, quality systems do not exist. A necessity for a quality
system management and a risk based classification system will be
included. It is planned that for Class A devices, the lowest risk level,
constructors will perform their private conformity assessment. Class B,
C and D devices will require valuation by an official informed body.
Imported medical devices that have CE Mark, FDA agreement or same
will be permitted on the market without suffering distinct conformism
valuate actions.