Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 229

Classification of
medical devices (a
risk-based
approached is
common for all the
classiication
systems).

(surgical gloves)
Class II special controls
(endoscopes)
Class III high-risk devices
(pacemakers)
Classification is based on
intended used of the
devices, indication of use of
the devices, and risk (from
lower risk to higher risk for
the patient).

stethoscopes)
Class I sterile
Class I measure
Class IIa medium- to low-risk
devices (e.g., electrocardiographs)
Class IIb medium- to high-risk
devices (intensive-care monitoring
system)
Class III high-risk devices (e.g.,
prosthetic heart valves)

dental accessories) only premarket
submission (self-declaration of
conformity) required , not certification
required by PMDA
Designated Controlled Medical
devices (class II) Premarket
Certification required through third
parties (similar to CE mark in
Europe) (e.g., tracheotomy tubes)
Controlled medical devices (class II
devices other than designated devices)
and highly controlled medical devices
(class III: orthopedic implants,
catheters; class IV: pacemakers, stents)
Pre-market approval required through
PMDA

Clinical trials for
high-risk devices
Examples:
drug-eluting stents,
coronary
guidewires

Clinical trials designed to
prove safety and
effectiveness (comparative,
large group trials with
longer approval times)

Clinical trials designed to prove
safety and performance (small
groups with faster approval times)

Clinical trials designed to prove safety
and effectiveness

( Continued )