Week 1 - topic 1a (medical devices classification Flashcards
Define the term “Medical devices”
Any instrument, apparatus, implement, or other similar or related article intended by the manufacturer to be alone or in combination for human beings for one or more of the specific purpose
•Diagnosis, prevention, monitoring, or alleviation of disease
•Diagnosis, monitoring, treatment, alleviation of or compensation of an injury
•Investigation, replacement, modification, or support of the anatomy of a physiological process
•Disinfection of medical devices derived
•Supporting or sustaining life control of conception
•Providing information for medical or diagnosis purpose by means of an in-vitro examination of specimens from the human body
Name the difference between medical device and drugs based on how is it administered
Medical devices act through physical interaction with body or body part while drugs are administered through mouth, skin, lungs, or by injection
Name the difference between medical device and drugs based on what is it used for
Medical devices are used for both diagnostic and therapeutic use while drugs are mainly for therapeutic use only.
Name the difference between medical device and drugs based on what does it consist of
Medical devices are physical object consists of complex components and assemblages; based on machenical, eletrical and material engineering. While drugs are pure molecules which is based on pharmacology and chemistry ; genetic engineering
Name the difference between medical devices and drugs based on its properties ( Hint: Is it incorporated by anything? )
Many medical devices are incorporated and are driven by software while drugs are pharmalogic properties and action of active ingredients based on pre-clincal studies. Software not incorporated.
Name the difference between medical device and drugs based on whether is it vitro or In-vitro
Medical devices can be used both Vitro and In-vitro while drugs are in-vitro used
Name the differenc between medical device and drugs based on how is it being developed
Medical device is developed by doctos, scientist, engineers using prototype before final product. Drugs on the other hand is developed by discovery, trail and approved by basis of safety and efficiency product developed in laboratories by chemist and pharmacology.
Why should medical devices be regulated and control
It enables products to be put safetly on the market and also enable to have a machanism to remove unsafe product from market. However primary goal is to protect public health and safety.
what can go wrong should medical device not be regualted and control
Counterfeits will be on sold on the market and there might also be a misrepresentation of the device performance.
What does GHTF stands for
Global harmonistion task force
What does IMDRF stands for
International medical deviec regulator fourm
What does AHWP stands for
Asian hormonisation working party
What does ACCSQ stands for
ASEAN cibsultaive comittee on standards & quality
why is harmonisation important in medical device
It is to encourage covergence in regulatory practices related to ensuring the safety, effectiveness/ performance and quality of medical devices, promoting technological innovation and facilitating international trade.
What does it mean by the term “ Regulatory Convergence” in medical device
Regulstory convergence is meant to represent a voluntary process whereby the regulatory requirement and approach across countries & religion become more similar or aligned over time as a result of the adaptation of the same technical document, standards & scientific principle and similar regulatory practices and procedures.
It also represent an important form of regulatory cooperation which in turn makes possible additional, enhanced forms of cooperation and collaboration between regulatory authority.
