Hi friends!!!
In our previous blog we had a introduction about Medical Device Single Audit Program, MDSAP Audit Cycle, Management process Audi. Please check out for the link below.
Medical Device Single Audit Program - Part 1
MDSAP Management Process Audit - Part 3
MDSAP Management Process Audit - Part 4
In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) CHAPTER 2 - Device Marketing Authorization and Facility Registration.
MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.
Let's get into the topic.
CHAPTER 2 – DEVICE MARKETING
AUTHORIZATION AND FACILITY
REGISTRATION
TASK 1 – Submission of Device Marketing Authorization and Facility
Registration.
TASK 2 – Evidence of Marketing Clearance or Approval.
TASK 3 – Notification of Changes to Marketed Devices or to the QMS.
Let's discuss about each task in detail.
TASK 1 – Submission of
Device Marketing
Authorization and Facility
Registration
Ensure that medical device organization has complied with requirements
to register and or license the device facilities. Verify whether medical device
organization has submitted device listing information to regulatory authorities
where it markets and distributes their products.
Ensure that the importers/MAHs/Sponsors have provided appropriate
information to applicable regulatory authorities indicating that the medical
device organization is the legal manufacturer even though the medical device
organization inappropriately considers themselves to be an original equipment
manufacturer.
The compliance of appropriate market authorization processes can be
checked by reviewing the labelling of the product being supplied to a
particular jurisdiction.
APPLICABLE REGULATORY STANDARDS AND CLAUSE
ISO 13485:2016: 4.1.1, 4.2.1,
5.2, 7.2.1, 7.2.3.
FDA: 21 CFR 807.
TGA: TG(MD)R Sch3 P1 CI1.8
ANVISA: RDC ANVISA 16/2013: 1.2.9.
To be considered as a registered manufacturing site, the medical device
organization has to submit an application to PMDA for registration by itself
according to PMD act 23-2-3.1, 23-2-4.
TASK 2 – Evidence of
Marketing Clearance or
Approval
Confirm that the medical device organization has received appropriate
marketing clearance or approval from applicable regulatory jurisdictions where
the medical device organization markets its devices.
APPLICABLE REGULATORY STANDARDS AND CLAUSE
ISO 13485:2016: 4.1.1, 4.2.1, 5.2, 7.2.1,
7.2.3.
AUSTRALIA: TG Act s41FJ, TG Act Part 4-7.
BRAZIL: ANVISA RDC nº 36/2015, RDC nº
40/2015.
JAPAN: PMD Act 23-2-5.1, 23-2-23.1,
23-2-12.
US FDA: 21 CFR 807.81- Premarket
Notification, 21 CFR 814 – Premarket Approval.
A medical device manufacturer should ensure that the product is not
released for supply to the Australian market until the sponsor has been issued
with a “Certificate of Inclusion in the Australian Register of Therapeutic
Goods”. It states that each kind of medical device that has been approved for
supply to the Australian market according to [TG Act s41FJ] or the sponsor
holds a relevant exemption as per (TG Act Part 4-7).
TASK 3 – Notification of
Changes to Marketed
Devices or to the QMS
Ensure that the medical device organization has arranged for assessment
of changes whenever applicable and obtained marketing authorization for changes
to devices or the quality management system which require amendment to existing
marketing authorization.
The audit team should pay attention to design changes that may require
notification to the applicable regulatory bodies to which the changed devices
are marketed.
APPLICABLE REGULATORY STANDARDS AND CLAUSE
ISO 13485:2016: 4.1.1, 4.2.1, 5.2, 7.2.1,
7.2.3, 7.3.9
AUSTRALIA: Therapeutic Goods (Medical
Devices) Regulations 2002: Regulation 3.5 – Medical devices manufactured
outside Australia, Schedule 3 - The relevant conformity assessment procedure
chosen by the Manufacturer.
JAPAN: PMD Act 23-2-5.1, 23-2-5.11,
23-2-5.12, 23-2-23.1, 23-2-23.6, 23-2-23.7.
CANADA: section 32 CMDR 34, section 34 or
43.1 CMDR 43, CMDR 43(3), section 34 CMDR 43.1.
US FDA: 21 CFR 807 - Establishment
Registration and Device Listing for Manufacturers and Initial Importers of
Devices, 21 CFR 814.39 – PMA Supplements, 21 CFR 807.81- Premarket Notification.
Auditing Organization should evaluate the
changes made by the medical device organization to determine whether there is a
requirement for special audit to verify the continuing integrity of the quality
management system. Adequacy of technical documentation as a result of the
change should also be verified by the auditing organization.
Examples of changes that may require an notification
for applicable regulatory bodies: Design, Composition, Raw material, Sterilization
method, Manufacturing method Manufacturing site Patient or user safety features,
Operating Parameters or conditions for use, Indication for use, Shelf life, Performance
Specification.
Now I hope you have acquired some knowledge about MDSAP Device Marketing Authorization and Facility Registration. We will discuss in detail about Medical Device Single Audit Program in our future blogs.
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