Regulatory Open Forum

Hi all,
I am reviewing the revised MDSAP Audit Approach (MDSAP AU P0002.007 revision date 2022-04-5) and found a requirement for Australia that I have not seen before. 

Chapter 4, Task 2 Notification of Advisory Notices.  
Australia (TGA):
Manufacturers are required to implement a post-marketing system that includes provisions for the recall of devices – e.g. Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3 Part 1 Clause 1.4 (3A). Under the MDSAP, and in view of the written agreement between Manufacturers and the Australian Sponsor [TG Act 41FD] (see Annex 4), proposed recalls must be reported by the Manufacturer to the MDSAP AO, and to the TGA or Sponsor in a timely manner to ensure that a Sponsor can meet their reporting obligations [Therapeutic Goods (Medical Devices) Regulation 5.7 and 5.8, Therapeutic Goods Act Part 4-9 and the Uniform Recall Procedure for Therapeutic Goods (URPTG)].

The call out that "proposed recalls must be reported by the Manufacturer to the MDSAP AO" is new.  I am trying to find the requirement in the Australian regulations or in the URPTG to report the proposed recall to our MDSAP Auditing Organization.  Any help in understanding this new requirement would be greatly appreciated.  Thank you.

------------------------------
Karen Golomb
Regulatory Affairs Director
Boerne TX
United States
------------------------------

Hi Karen,

I have not seen this in the Australian regulations either and I am not sure you will find a specific reference.  Please keep in mind the MDSAP programme is an auditing approach sitting outside of the individual country regulations.  While much of the MDSAP activities reference to the country regulatory requirements, there are a few of these "hidden eggs" where additional requirements appear in the MDSAP documents.  In addition, you will most likely find these additional requirements in the contract with your Auditing Organisation (AO).  If an organisation decides to participate in the MDSAP programme, not only following all applicable regulatory requirements, but there are additional needs from the MDSAP programme also.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 27-Apr-2022 18:50
From: Karen Golomb
Subject: Australia and MDSAP

Hi all,
I am reviewing the revised MDSAP Audit Approach (MDSAP AU P0002.007 revision date 2022-04-5) and found a requirement for Australia that I have not seen before.

Chapter 4, Task 2 Notification of Advisory Notices.
Australia (TGA):
Manufacturers are required to implement a post-marketing system that includes provisions for the recall of devices – e.g. Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3 Part 1 Clause 1.4 (3A). Under the MDSAP, and in view of the written agreement between Manufacturers and the Australian Sponsor [TG Act 41FD] (see Annex 4), proposed recalls must be reported by the Manufacturer to the MDSAP AO, and to the TGA or Sponsor in a timely manner to ensure that a Sponsor can meet their reporting obligations [Therapeutic Goods (Medical Devices) Regulation 5.7 and 5.8, Therapeutic Goods Act Part 4-9 and the Uniform Recall Procedure for Therapeutic Goods (URPTG)].

The call out that "proposed recalls must be reported by the Manufacturer to the MDSAP AO" is new.  I am trying to find the requirement in the Australian regulations or in the URPTG to report the proposed recall to our MDSAP Auditing Organization.  Any help in understanding this new requirement would be greatly appreciated.  Thank you.

------------------------------
Karen Golomb
Regulatory Affairs Director
Boerne TX
United States
------------------------------