Hi friends!!!

In our previous blog we had a introduction about Medical Device Single Audit Program, MDSAP Audit Cycle, Management process Audit, Device marketing authorization and facility registration, MDSAP Measurement, Analysis and Improvement Process. Please check out for the link below.

Medical Device Single Audit Program - Part 1

MDSAP Audit Cycle - Part 2

MDSAP Management Process Audit - Part 3

MDSAP Management Process Audit - Part 4

MDSAP Device Marketing Authorization and Facility Registration - Part 5

MDSAP Measurement, Analysis and Improvement - Part 6

MDSAP Measurement, Analysis and Improvement - Part 7

In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) CHAPTER 4 - Medical Device Adverse Events and Advisory Notices Reporting.

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 4 – Medical

Device Adverse

Events And Advisory

Notices Reporting

Task 1 – Notification of Adverse Events

Task 2 – Notification of Advisory Notices

Let’s discuss in detail about each tasks.

Task 1 – Notification of Adverse Events

Ensure that the medical device organization has implemented the procedure for identifying device related events which meets the reporting criteria set by applicable regulatory authorities.

Ensure that the medical device organizations procedure has special features to review the complaints to determine whether reporting to applicable regulatory authorities is required or not.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 7.2.3, 8.2.2, 8.2.3

AUSTRALIA

Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3 Part 1 Clause 1.4(3)(c)(i).

As per Australia’s TGA, Medical Device manufacturers are required to implement effective post marketing system that includes provision for adverse event reporting.

The reporting timelines as per TGA are as follows.

1. The event that represents a serious threat to public health should be reported to regulatory authorities within 48 hours.

2. The event that led to the death or serious deterioration in the state of health of a patient should be reported within 10 days.

3. The event that the recurrence of which might lead to the death or serious deterioration in the state of health of a patient should be reported within 30 days.

BRAZIL

RDC ANVISA 67/2009 – Art. 6º

Ensure that the medical device organization has procedure for correct and prompt identification of adverse events. The safety and performance of the device has to be improved based on the results of investigation.

RDC ANVISA 67/2009 – Art. 5º

As per Brazil regulations, Ensure that the medical device organizations top management has appointed specific person responsible for post marketing surveillance system.

RDC ANVISA 67/2009 – Art. 8º

Ensure that the medical device organization is reporting to the notified bodies about the adverse events and other problems.

RDC ANVISA 67/2009 – Art. 8º

Ensure that the legal representative in brazil for an international manufacturer is aware of the health hazards and possibility of death while using a medical device.

CANADA

Medical Device Regulations SOR/98-282, Section 59-61.1

Ensure that the medical device manufacturer and importer is making a preliminary and final report to the ministry concerning any incident happening inside or outside Canada involving a medical device sold in Canada.

Reporting should be made in case of failure of the device, deterioration of its efficiency and inadequacy in labelling or instructions for use.

Reporting should be made in case of death or serious health deterioration to user, patient or public.

As per CMDR 60 (1) (a) (i), Ensure that the medical device organization is aware of the incident and should report about the incident within 10 days from the date of receiving information about the incident.

Ensure that the medical device Manufacturer has made effective arrangements to submit preliminary reports to the concerned Ministry and that the reports shall contain the details as per CMDR 60 (2).

Ensure that the medical device Manufacturer has submitted final reports to the concerned Ministry in writing in accordance with the timetable established under CMDR 60(2)(h) and that the reports shall contain the details as per CMDR 61 (1).

JAPAN

As per MHLW, Marketing authorization holders are required to maintain a effective post market surveillance system as per domestic Japanese regulatory requirements and QMS requirements.

Ensure that the persons operating the registered manufactured site shall reporting the adverse events coming under PMD Act Article 228-20.2 to the marketing authorization holder as per MHLW MO169: 62.6, instead of directly reporting to the regulatory authorities.

FDA

Ensure that the medical device organisation has implemented procedures for reporting to FDA about incidents involving death, serious health issues etc.

The medical device organisation shall report to FDA within 30 days from the day, they are aware of the incident.

Ensure that the medical device organisations, medical device reporting (MDR) files contain information regarding all the documents, decision making processes used to determine whether a incident is reportable or non-reportable to FDA. Copy of all MDR forms and all the information related to adverse events shall be submitted to FDA.

Ensure that the medical device organisation evaluates events in accordance with the QMS requirements to make FDA consider the submitted MDR files in compliance with 21 CFR 803.

Ensure that the MDR files submitted to FDA contains UDI number that is printed on the device label.

The MDR files submitted to the FDA shall be submitted electronically via the Electronic Submissions Gateway (ESG) using eSubmitter or the AS2 Gateway-to-Gateway using HL7 ICSR XML software.

Task 2 – Notification of Advisory Notices

Ensure that the medical device organisation submits the advisory notices to the regulatory authorities within the stipulated timelines. Verify that the medical device organisation is keeping all the records related to advisory notes and satisfying all the record keeping requirements as per applicable regulatory bodies.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 7.2.3, 8.2.3, 8.3.3

AUSTRALIA (TGA)

As per Australia’s TGA, medical device organisation shall establish a effective PMS system for recovery of products.

TG Act 41FD

All details regarding the recall of products shall be reported to TGA by the manufacturer or Australian sponsor in a timely manner.

TG(MD)R Reg 5.8

Meanwhile sponsors are required to provide all the details about conformity assessment procedure to the manufacturer.

BRAZIL

RDC ANVISA 67/2009 - Art. 6º, RDC ANVISA 23/2012 – Art. 1º, Art. 5º

The medical device organisation shall implement procedure to identify when field actions (recalls) are required.

RDC ANVISA 23/2012 – Art. 4º; Art. 6º, Art. 10, Art. 11, Art. 16

Describes the record keeping activities of medical device manufacturers.

RDC ANVISA 23/2012 – Art. 4º, Art. 6º, Art. 7º, Art. 13, Art. 14, Art. 15

In order to perform field actions and recalls, medical device organisation shall provide evidence justifying that their product does not comply with the requirements of safety and effectiveness.

RDC ANVISA 67/2009 – Art. 8º

In case of international manufacturer, the legal representative in Brazil should be aware of the recalls performed on the devices exported to brazil by international manufacturer.

CANADA

Medical Device Regulations SOR/98-282, Section 63 – 65.1.

The medical device manufacturer or importer shall provide the required details on or before undertaking a recall to the applicable ministry as per CMDR 64.

The medical device manufacturer shall also report the results of the recall and corrective actions taken to the applicable ministry as per CMDR 65.

In case the reports were submitted by the importer, manufacturer shall write to the applicable ministry stating that the manufacturer had permitted the importer to prepare and submit the reports to the ministry as per CMDR 65.1.

JAPAN

PMD Act 68-11

The marketing authorization holder shall report to the applicable regulatory bodies about the advisory notices issued.

MHLW MO169: 29

The person operating the manufacturing site does not need to directly report to regulatory authorities about the advisory notices, whereas it is important for him to report to marketing authorization holder so that they can communicate to regulatory authorities.

UNITED STATES (FDA)

21 CFR 806: Medical Devices; Reports of Corrections and Removals

Reports regarding the recalls or corrective action shall be submitted to FDA within 10 days from the date of initiation of recall or corrective action.

Ensure that the medical device organisations report contains the UDI that appears on the device label or on the device package, or the device identifier, Universal Product Code (UPC), model, catalog, or code number of the device and manufacturing lot or serial number of device or other identification number.

The medical device manufacturer are supposed to maintain records of recalls even when there is no requirement to report to FDA.

Now I hope you have acquired some knowledge about MDSAP Chapter 4 - Medical device adverse events and advisory notices reporting. We will discuss in detail about remaining chapters of 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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