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.

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

The following are the tasks to be performed during device marketing authorization and facility registration audit.

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.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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