Countdown to RegConnect Challenge

Test your regulatory know-how and earn your way to the 2026 Summit! From Monday 29 June to Friday 31 July, answer a new question each weekday (25 in total) covering the topics, trends, and themes shaping the global MedTech regulatory landscape. Complete the challenge for your chance to win tickets to the RegConnect Summit (24–25 September, ICC Sydney), one question at a time.

Today's Question

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Previous Questions

25. A Class IIa device has been on the ARTG for three years. The manufacturer updates the device’s software, changing the algorithm that processes patient data but not its intended purpose or outputs. What is most likely required of the sponsor? 31 July 2026

Nothing - software updates to existing devices do not require TGA notification
A fresh ARTG application, as any software change constitutes a new device
Assessment of whether the change is significant under the Essential Principles and notifying TGA if it is Correct answer
Automatic reclassification to Class IIb due to the addition of software functionality

24. Under TGA’s framework, what is the general relationship between a hazard alert and mandatory adverse event reporting obligations? 30 July 2026

Hazard alerts can only be issued once every mandatory report has been fully investigated and closed
A hazard alert automatically fullfills all other reporting obligations for the same issue
Mandatory reporting obligations are suspended for the duration any hazard alert remains active
A hazard alert doesn't itself replace separately applicable mandatory reporting duties Correct answer

23. An accessory to a medical device: 29 July 2026

Always inherits the same classification as the principal device it supports
Is excluded from regulation as it is not itself a medical device
Is exempt from ARTG inclusion if supplied in the same package as an included device
May be classified independently of the principal device based on its own risk profile Correct answer

22. Under the National Statement-aligned framework for clinical trials in Australia, which body’s approval is generally required before a clinical trial involving an unapproved medical device can commence at a site, in addition to TGA notification/approval pathways as applicable? 28 July 2026

21. In the EU MDR system, manufacturers must appoint which role within their organisation? 27 July 2026

20. A device sponsor in Australia issues a market action reclassified partway through execution, initially treated as a hazard alert, later escalated. What is TGA’s expectation regarding this kind of reclassification? 24 July 2026

Reclassification is not permitted once a market action begins
Reclassification automatically triggers ARTG cancellation
Only TGA can reclassify a market action; sponsors have no role
Sponsors must notify TGA and adjust the action's classification and communications as new information changes the risk assessment Correct answer

19. A New Zealand-supplied device is regulated under the Medicines Act 1981’s medical device provisions pending the new Therapeutic Products framework. Which statement is accurate about NZ’s current device regulatory model? 23 July 2026

NZ operates a full pre-market approval system identical to TGA's ARTG
NZ currently relies primarily on a notification-based system rather than pre-market device approval Correct answer
NZ requires FDA clearance as a mandatory precondition for supply
NZ has no medical device regulation at all

18. A US manufacturer submits a 510(k) citing a predicate that was itself cleared via De Novo. Is this permissible? 22 July 2026

Only if the predicate device has been on market over 10 years
Only with a pre-submission meeting waiver from FDA
Yes, a granted De Novo creates a new predicate usable in future 510(k)s Correct answer
No, De Novo-cleared devices can never serve as predicates

17. A sponsor wants to supply a device under the Special Access Scheme Category C (SAS-C) notification pathway. What is the key distinguishing feature of SAS-C compared to SAS-A and SAS-B? 21 July 2026

SAS-C requires the most extensive pre-approval documentation of the three categories
SAS-C is a notification-based pathway (post-supply notification) for specified circumstances, generally involving lower regulatory friction than the approval-based SAS-A/B pathways Correct answer
SAS-C only applies to therapeutic goods, never medical devices
SAS-C requires the same individual patient approval process as SAS-B

16. A UK-based manufacturer’s device carries UKNI marking. Under what circumstance is UKNI marking specifically required, as distinct from UKCA? 20 July 2026

UKNI is required for all devices sold anywhere in the UK, replacing UKCA entirely
UKNI applies specifically to devices placed on the market in Northern Ireland Correct answer
UKNI is an alternative name for UKCA with no substantive difference
UKNI only applies to Class I devices

15. Under TGA’s Essential Principles framework, how do the Essential Principles compare structurally to the EU MDR’s General Safety and Performance Requirements (GSPRs)? 17 July 2026

They are legally identical texts adopted by treaty
They are broadly harmonised in intent and structure (both derived from GHTF/IMDRF foundations) but are separate, jurisdiction-specific legal requirements, not directly interchangeable compliance evidence Correct answer
The Essential Principles are a subset of the GSPRs with no additional Australian-specific requirements
GSPRs apply only to IVDs, while Essential Principles apply only to non-IVD devices

14. A manufacturer’s device is classified Class IIb under EU MDR and undergoes a change of Notified Body mid-certificate-cycle. What is the status of the existing CE certificate during the transfer? 16 July 2026

It remains automatically valid indefinitely under the new Notified Body without any transfer process
It becomes void the moment the manufacturer signs a contract with the new Notified Body
A formal transfer process applies, and the certificate's validity during transition depends on coordination between the outgoing and incoming Notified Bodies per MDCG guidance Correct answer
The device must be withdrawn from market for the duration of the transfer regardless of documentation status

13. Under the TGA’s UDI implementation timeline, a Class I non-sterile, non-measuring device manufacturer questions whether UDI carrier requirements apply to their product ahead of the general staged rollout. Which factor is most determinative of their actual compliance deadline? 15 July 2026

Device classification alone determines the deadline, with no other variables
All devices, regardless of class, share an identical UDI compliance date
UDI requirements only apply to devices with a GTIN already assigned, so devices without one are exempt indefinitely
The manufacturer's staged implementation cohort, which depends on factors including device class and whether the device is legacy stock already in the supply chain versus newly supplied product Correct answer

12. Comparing TGA’s “Priority Applicant” pathway with “Provisional Approval,” which is the more accurate distinction? 14 July 2026

Priority Applicant status expedites review timeframes for eligible applications; Provisional Approval is a distinct approval pathway allowing earlier market entry based on preliminary clinical data with conditions attached Correct answer
Provisional Approval expedites timeframes only; Priority Applicant is the conditional-approval pathway
They are the same pathway under different names
Both require the same clinical evidence threshold, differing only in fee structure

11. Under the EU MDR (2017/745), which classification rule primarily governs software as a medical device (SaMD)? 13 July 2026

10. Under the FDA’s framework, what is the key practical difference between a 510(k) clearance and a De Novo classification request? 10 July 2026

They are identical processes with different names
510(k) requires demonstrating substantial equivalence to a predicate; De Novo is used when no predicate exists for a low-to-moderate risk device Correct answer
De Novo only applies to Class III devices
510(k) is only for combination products

9. Under Australia’s TGA framework, what specifically distinguishes a “Special Access Scheme (SAS)” pathway from standard ARTG inclusion? 9 July 2026

It applies only to devices manufactured in Australia
It allows access to an unapproved device for an individual patient or defined cohort under specific clinical circumstances Correct answer
It's a faster general registration pathway for all devices
It removes the need for any clinical evidence permanently

8. What does “GMDN” stand for? 8 July 2026

7. What is a “Notified Body” under the EU MDR? 7 July 2026

6. Which of the following countries currently participate in the MDSAP? 6 July 2026

5. Under the TGA’s conformity assessment framework, when can a manufacturer rely on a Comparable Overseas Regulator (COR) pathway rather than full TGA conformity assessment? 3 July 2026

Only for Class I devices
Where the device holds current certification from a recognised comparable regulator and TGA-specific requirements are also met Correct answer
For any device, provided the sponsor pays an expedited fee
Never, as COR was discontinued in the 2021 reforms

4. Who is legally responsible for a device’s ongoing compliance with the Essential Principles once it’s on the market? 2 July 2026

3. Which Commonwealth department does the TGA sit within? 1 July 2026

2. Which standard is most associated with Quality Management Systems for medical devices? 30 June 2026

1. What does IMDRF stand for? 29 June 2026

Leaderboard

#	Name	Correct	Answered
🥇	Chris Masson	25	25
🥈	Sugashine Jeganathan	24	25
🥉	Amber Yalcinkaya	23	23
4	Hye-Lim Kim	22	22
5	Aathira Hari	21	22
6	HEENA VYAS	18	18
7	Sebastian Castiblanco	18	18
8	Falko Thiele	16	16
9	Louise Pirauo	12	13
10	Ruth Black	11	11
11	Mandy Dunn	6	6
12	Fleur Winslade (Terumo)	3	3
13	Hemangi Malde	3	3
14	Preeti Virdi	2	3
15	Athena Carfax-Foster	2	2
16	Matylda Jaworski	2	2
17	Leanne Etherington	1	1
18	Rinku Bhandari	1	1
19	Ram Kannan	1	1
20	Venkata Methra	1	1
21	Richard Malyn	1	1
22	Kellie Shaw	1	1
23	Marie Mc Caffrey	1	1
24	Christina Eder	1	1
25	Jenner Rosendale	1	1
26	Angell Zhang	1	1
27	Ashwini Kamat	0	1

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