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RAC Exam Prep 2023 - International Regulatory/Questions And Answers
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RAC Exam Prep 2023 - InternationalRegulatory/Questions And Answers
Quiz :Members of IMDRF - √Answer :Australia, Brazil, Canada, China, Europe,
Japan, Russia, Singapore, S. Korea, US
Quiz :What types of evaluations are typical variable from nation to nation? -
√Answer :Performance and clinical evaluations
Quiz :What is the Helsinki Declaration? - √Answer :statement of ethical
principles for medical research involving humans
Quiz :What are the 5 elements of a conformity assessment? - √Answer :1. QMS
2. PMS
3. Technical doc summary
4. Declaration of conformity
5. Manufacturer and med device registration with the regulatory authority
Quiz :What does the MDSAP allow? - √Answer :A single audit of a device
manufacturer's QMS, this satisfies the requirements of multiple reg authorities
(countries)
Quiz :What are the countries participating in MDSAP? - √Answer :Australia,
Brazil, Canada, Japan, US
Quiz :In which country is the MDSAP the only route to approval (as of Jan
2019)? - √Answer :Canada
Quiz :Generally, MDSAP reduces what? - √Answer :the number of similar audits
Quiz :STED = - √Answer :Summary Technical Documentation
...for demonstrating conformity to the essential principals of safety and
performance of medical devices
Quiz :GHTF/SG1/N011:2018 covers the - √Answer :Essential Principals of safety
and performance
Quiz :The Essential Performance (EP) checklist is part of ... - √Answer :the
manufacturers technical documentation
, Quiz :Define EP Checklist - √Answer :a controlled document within the QMS
that provides a tabular overview of the essential requirements identifying
those applicable to the device and demonstrating the device conforms to each
Quiz :GHTF/SG1/N78:2012 - √Answer :Principals on conformity assessment for
medical devices
Quiz :Define Declaration of Conformity (DoC) - √Answer :a signed statement
the manufacturer draws up declaring that the device fully applies to applicable
ERs.
Quiz :3 things a DoC declares/claims... - √Answer :-Identifies the manufacturer
and the med devices subject to the declaration
Attests to the compliance if the med device to the ERs
- confirms the device has been classified properly and meets all required
conformity assessments
Quiz :Define Authorized Representative - √Answer :(GHTF/SG1/N055:2009) A
person established within a country or jurisdication who has recieved a written
mandate from the Manf. to act on their behalf for specified tasks with regards
to the Manf's obligation under the specific legislation
Quiz :GHTF medical device classes - √Answer :Class A - lowest risk
Class B
Class C
Class D - highest risk
Quiz :Rule 1 - √Answer :Non-invasive (NI) devices that come in contact with
injured skin - Class A if simple dressing, Class B or C for wounds deeper, more
serious wounds
Quiz :Rule 2(I) - √Answer :All NI devices for storing/transferring liquids to be
intro'd to a body eventually. Class A unless for blood/organ then Class B. Blood
Bags = Class C
Quiz :Rule 3 - √Answer :NI intended to modify bio/chem composition of
blood/other liquid meant for infusion. Mainly Class C, some class B
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