MEDICAL DEVICE GUIDANCE
GN-10: Guidance on Medical Device Field Safety
Corrective Action
Revision 3.5
January 2019
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CONTENTS
PREFACE ........................................................................................................ 3
1. INTRODUCTION ....................................................................................... 4
1.1. Purpose ................................................................................................. 4
1.2. Background ........................................................................................... 4
1.3. Scope .................................................................................................... 4
1.4. Definitions.............................................................................................. 5
2. DETERMINING THE NEED FOR A FSCA ................................................ 9
3. NOTIFICATION OF FSCA ......................................................................... 9
4. WHO NEEDS TO NOTIFY FSCA TO THE AUTHORITY? ...................... 11
5. INITIATION OF FSCA IN SINGAPORE .................................................. 11
6. REPORTING TIMELINES ....................................................................... 12
7. PRESCRIBED FORM AND MANNER FOR SUBMISSIONS .................. 13
8. INFORMATION FOR INCLUSION IN FSCA REPORT SUBMISSIONS .. 14
8.1. Information to be provided as part of the MDRR1 Notification or
Preliminary Report ............................................................................... 15
8.2. Information to be provided as part of the Final or Follow-Up Report ... 17
8.3. Information to be provided as part of the MDRR3 Notification Report . 18
8.4. Identification of affected device information in FSN ............................. 19
9. FSCA INVOLVING CONSUMER-LEVEL MEDICAL DEVICES ............... 19
10. FSCA INVOLVING IMPLANTABLE MEDICAL DEVICES ....................... 20
11. RISK MANAGEMENT PROCESS FOR SUPPLY OF MEDICAL
DEVICES. ................................................................................................ 21
12. COMPLIANCE TO NOTICES .................................................................. 23
13. PUBLICATION OF FIELD SAFETY NOTICES ON HSA WEBSITE ........ 24
13.1. FSN Requirements for Publication ............................................... 24
14. COMPLETION OF REPORTING OBLIGATIONS FOR FSCA ................ 25
ANNEX 1 ....................................................................................................... 27
ANNEX 2 ....................................................................................................... 28
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PREFACE
R3.1 ►This document is intended to provide general guidance. Although we
have tried to ensure that the information contained here is accurate, we do
not, however, warrant its accuracy or completeness. The Health Sciences
Authority (HSA) accepts no liability for any errors or omissions in this
document, or for any action/decision taken or not taken as a result of using
this document. The information contained in this document should not be a
substitute for professional advice from your own professional and healthcare
advisors. ◄
CONTACT INFORMATION
Email (post-market submissions): [email protected]
REVISION HISTORY
Guidance Version (Publish Date) [3 latest revisions]
Revision
GN-10: Revision 1 (October 2008)
R1
R2 ►GN-10: Revision 2 (September 2013)
R2
R3 ►GN-10: Revision 3 (April 2016)
R3
R3.1 ►GN-10: Revision 3.1 (01 November 2017)
R3.2 ►GN-10: Revision 3.2 (01 June 2018)
R3.1
R3.2
R3.3 ►GN-10: Revision 3.3 (21 August 2018)
R3.3
R3.4 ►GN-10: Revision 3.4 (03 October 2018)
R3.4
R3.5 ►GN-10: Revision 3.5 (08 January 2019)
R3.5
*Where applicable, changes and updates made in each document revision are
annotated with or within the arrow symbol “►”. Deletions may not be shown.
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1. INTRODUCTION
1.1. Purpose
This document is meant to provide guidance on Field Safety Corrective Action
(FSCA).
1.2. Background
The Health Products Act (Act) and Health Products (Medical Devices)
Regulations 2010 (Regulations) requires FSCAs to be reported to the
Authority.
A FSCA is required when it becomes necessary for the product owner of the
medical device to take action (including recall of the device) to eliminate, or
reduce the risk of, the hazards identified.
A FSCA may still be necessary even when the medical device is no longer on
the market or has been withdrawn but could still possibly be in use (e.g.
implants).
For further information on specific requirements that apply to recalls, please
refer to the GN-04: Guidance on Medical Device Recall.
1.3. Scope
This document is applicable to all persons who register, manufacture, import
and/or supply medical devices in Singapore.
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1.4. Definitions
Definitions that do not indicate they are set out in the Act or Regulations are
intended as guidance in this document. These definitions are not taken
verbatim from the above legislation and should not be used in any legal
context. These definitions are meant to provide guidance in layman terms.
AFFECTED DEVICE: R3.5 ► a medical device that is affected or likely to be
affected by the problems, issues, or deficiencies identified by the product
owner of the medical device that could impact the safety, quality and/ or
efficacy of the medical device. The affected medical device information (e.g.
model identifiers) is typically presented in the product owner’s field safety
notice. ◄
CONSIGNEE: anyone who received, purchased or used the device
undergoing a Field Safety Corrective Action.
CONTROL NUMBER: a unique series of letters, numbers or symbols, or any
combination of these, that is assigned to a medical device by the product
owner and from which a history of the manufacture, packaging, labelling and
distribution of a lot or batch of the device can be determined.
CORRECTION: an action to eliminate a detected nonconformity including the
repair, modification, adjustment, relabeling, or inspection (including patient
monitoring) of a device.
CORRECTIVE AND PREVENTIVE ACTION (CAPA): actions taken to
address the identified root cause for the device problem or issue for which the
FSCA was initiated. This can include amongst others, post-market
surveillance, recalls, or corrective or preventive actions related to the design
and manufacture of the device.
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CORRECTED DEVICE: a medical device which is affected by the FSCA and
has completed CAPA intended by the product owner to wholly correct for the
FSCA.
CORRECTION-IN-PROGRESS DEVICE: a medical device which is affected
by the FSCA and has not completed the CAPA intended by the product owner
to wholly correct for the FSCA; i.e. devices having interim risk mitigation
measures will be considered as a correction-in-progress device.
DEALER: any manufacturer, importer, supplier or registrant conducting the
FSCA in Singapore.
NOTE: The dealer could either be (i) initiating the FSCA on their own accord as the
product owner, (ii) initiating the FSCA on behalf of the product owner, or (iii) initiating the
FSCA as mandated by the Authority.
EFFECTIVENESS CHECK: verification checks conducted, which can include
surveys of those affected by the FSCA (consignees) to verify they have
received the FSCA information and are aware of any appropriate action to be
taken and may include verification of the action taken. The manufacturer,
importer, supplier or registrant is responsible for conducting effectiveness
checks, which may also be undertaken, or verified, by the Authority.
FIELD SAFETY CORRECTIVE ACTION (as set out in the Regulations): any
action taken to reduce a risk of death or serious deterioration in the state of
health associated with the use of a medical device, including
the return of the medical device to its product owner;
replacement or destruction of the medical device;
any action regarding the use of the medical device that is taken in
accordance with the advice of its product owner;
the clinical management of any patient who has used the medical
device;
the modification of the medical device;
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the retrofitting of the medical device in accordance with any modification
to it or any change to its design by its product owner;
the making of any permanent or temporary change to the labelling or
instructions for use of the medical device; or
any upgrade to any software used with the medical device, including any
such upgrade carried out by remote access.
FSCA STRATEGY: a planned course of action taken by the dealer conducting
a specific FSCA, including but not limited to the depth of FSCA, the need for
public warnings, and the extent of effectiveness checks for the FSCA.
NOTE: The depth of the FSCA refers to whether the FSCA has to be conducted at
the wholesale, retail or consumer level, etc.
FIELD SAFETY NOTICE (FSN): A communication sent out by a product
owner or its representative to the device users in relation to a FSCA. This
communication shall include the product identifier of affected units and a field
for the consignee to acknowledge that he has understood the contents of the
FSN.
HEALTH HAZARD ASSESSMENT (HHA): the scientific characterisation of
the probability of occurrence and severity of known or potential adverse health
effects resulting from exposure to hazards. The process generally consists of
the following steps: (i) hazard identification (ii) hazard characterisation, (iii)
exposure assessment, and (iv) risk characterisation.
MEDICAL DEVICE (as set out in the Act): means a medical device as
described in the First Schedule of the Act.
PRODUCT OWNER (as set out in the Regulations): in relation to a health
product, means a person who —
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supplies the health product under his own name, or under any trade mark,
design, trade name or other name or mark owned or controlled by him;
and
is responsible for designing, manufacturing, assembling, processing,
labelling, packaging, refurbishing or modifying the health product, or for
assigning to it a purpose, whether those tasks are performed by him or on
his behalf.
QUALIFIED PRACTITIONER (as set out in the Regulations): means —
a registered medical practitioner under the Medical Registration Act
(Cap. 174), when acting in the course of providing medical treatment to a
patient under his care; or
a registered dentist under the Dental Registration Act (Cap. 76) whose
name appears in the first division of the Register of Dentists maintained and
kept under section 13(1)(a) of that Act, when acting in the course of providing
dental treatment to a patient under his care.
QUARANTINE: effective restriction of the availability of material or device for
use or distribution by the dealer or qualified practitioner, until released by a
designated authority.
RECALL: any action taken to remove the medical device from the market or to
retrieve the medical device from any person to whom it has been supplied,
because the medical device —
may be hazardous to health; or
may fail to conform to any claim relating to its quality, safety or efficacy.
ROOT CAUSE ANALYSIS: an analysis into the most likely reason(s) why a
problem or issue had occurred with the medical device.
STOCK RECOVERY: a dealer’s removal or correction of a medical device
that has not been supplied or that has not left the direct control of the dealer.
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2. DETERMINING THE NEED FOR A FSCA
The product owner of the medical device in question is responsible for
determining the need for a FSCA.
FSCA may be triggered when information from the product owner’s post
market surveillance (including product complaints, adverse incidents, etc.)
indicates an unacceptable increase in risk.
Where necessary, the Health Sciences Authority (“Authority”) may instruct
product owners or their representative to implement a FSCA in relation to a
medical device due to risk of serious injury or death to patients, users or
others. Such risks are usually identified through adverse events reports or
other means.
In certain cases, it may be necessary to use precautionary measures in the
interest of public health and restrict or prohibit products subject to particular
requirements. It may also be necessary to remove a medical device from the
market. Risk communication to the general public may be necessary to
ensure effective conduct of the FSCA.
3. NOTIFICATION OF FSCA
If medical devices affected by the FSCA have been manufactured, imported
or supplied in Singapore, or have obtained a valid marketing authorization for
local supply, the FSCA shall require notification to the Authority. The dealer
that manufactured, imported or supplied the affected devices shall ensure that
necessary measures (e.g. initiation of FSCA, stock recovery, etc.) in relation
to the FSCA are undertaken without any undue delay.
Refer to Diagram 1 below for FSCA report submission decision flowchart.
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Diagram 1 FSCA Report Submission Decision Flowchart
Do affected devices
currently have
marketing
authorization*?
FSCA Reporting NOT required
START HERE
Yes
Yes
Yes
No
No
No
MDRR1 reporting
Yes
Is there unsupplied
physical stock of
affected devices in
Singapore?
No
MDRR3 reporting
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*NOTE: For the purposes of this guidance, marketing authorisation would
refer to either (i) registration on the Singapore Medical Device Register (SMDR), (ii)
placement on the Transition-List or (iii) Special Authorisation Routes for local supply (GN-26,
GN-27, GN-29 or GN-30(CR).
NOTE: In cases where the medical devices affected by the FSCA have been
imported but not supplied in Singapore or have obtained marketing authorisation from the
Authority but have not been manufactured, imported or supplied in Singapore, a MDRR3
report form shall be submitted.
R3.5 ► NOTE: Under circumstances where there is a subsequent clinical need for
the devices affected by the FSCA reported under MDRR3, a review would be required prior to
any supply. Hence, a subsequent MDRR1 report should be submitted to the Authority. ◄
NOTE: In cases where the medical devices affected by the FSCA have been
manufactured in Singapore, a MDRR1 report form shall be submitted, regardless of whether
the affected medical devices have been supplied in Singapore.
4. WHO NEEDS TO NOTIFY FSCA TO THE AUTHORITY?
The party that performs the reporting obligations to the Authority is also
referred to as the reporting person. The dealer that manufactured, imported or
supplied or obtained marketing authorisation for the affected devices in
Singapore shall be the reporting person. In cases, where more than one
dealer has manufactured, imported or supplied the affected devices in
Singapore, each dealer that manufactured, imported or supplied the affected
devices may be required to report individually.
NOTE: However, in certain cases, if complete distribution and stock inventory details
on affected devices can be obtained from one or more of the reporting persons, report
submission from each of the dealers may not be requested by the Authority.
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5. INITIATION OF FSCA IN SINGAPORE
Once the product owner initiates the FSCA, and affected devices have been
supplied in Singapore, the implementation of the FSCA should not be
delayed.
Prior to the initiation of the FSCA in Singapore, under the Regulations, it is a
requirement that the FSCA is notified to the Authority. Once the FSCA is
notified to the Authority, the dealer may proceed to initiate the FSCA or
conduct stock recovery unless otherwise instructed by the Authority.
Dissemination of the product owner’s FSN and implementation of the
corrective actions listed in the FSN are some measures (but not limited to)
that constitute initiation of the FSCA.
Once notified to the Authority, an approval from the Authority to proceed with
dissemination of the FSN or conduct of the FSCA is not required. However,
the Authority may instruct the dealer to perform additional measures (in
relation to the FSCA) that are deemed necessary to safeguard public health.
In certain cases, the Authority may require amendments to the FSCA risk
communication or FSCA strategy. Nevertheless, to ensure timely
communication, the dealer should inform all affected consignees (e.g. through
the dealer’s initial FSN) of the FSCA. Where amendments to the FSCA risk
communication or FSCA strategy are required, the Authority may require the
dealer to issue a subsequent risk communication to further clarify with the
affected consignees on amendments to the FSCA strategy.
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6. REPORTING TIMELINES
FSCA that falls under MDRR3 reporting should be submitted within 30 days of
the initiation in any country globally.
The FSCA MDRR1 Notification Report should be submitted before the
initiation of FSCA or stock recovering in Singapore. There shall not be any
undue delay in the initiation of the FSCA in Singapore once the product owner
has initiated the FSCA globally.
Note: An acknowledgement notice for the FSCA Notification Report would be
issued by the Authority after the submission of the FSCA Notification Report.
A Preliminary report, if requested by the Authority, shall be submitted within
24 hours after the commencement of the FSCA. A Follow-up or Final report is
to be submitted to the Authority within 21 days from the date of
commencement of the FSCA.
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7. PRESCRIBED FORM AND MANNER FOR SUBMISSIONS
All reports shall be submitted in the following form and manner that the
Authority prescribes:
Form# MDRR1 for Notification/Preliminary reporting of FSCAs that require
initiation in Singapore
Form# MDRR2 for Follow-up/Final reporting of FSCAs that require
initiation in Singapore
Form# MDRR3 for reporting of medical device related post-market
information
Refer to Diagram 1 for the decision flowchart on the FSCA report form to
submit.
NOTE: For submission of FSCAs where the affected medical devices have been
imported but not supplied in Singapore or have obtained marketing authorisation from the
Authority but have not been manufactured, imported or supplied in Singapore, a MDRR3
report form shall be submitted.
Submission is via email as described in the forms. A scanned copy of the
completed hardcopy FSCA Report is to be submitted, together with other
accompanying documents/ information. Email size should be under 2MB.
NOTE: For email size above 2MB, please split the email accordingly to ensure that
each email has a size of no more than 2MB.
Report forms are to be signed and dated. No unauthorised changes to the
form shall be performed. The Authority reserves its right to reject reports that
have not been received in the form or manner it prescribes.
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8. INFORMATION FOR INCLUSION IN FSCA REPORT SUBMISSIONS
When the need for a FSCA has been established, the product owner or its
representative should gather all relevant information on the medical device
and its distribution, and the action proposed. Some information may not be
available immediately (e.g. distribution chains, batch size etc.). Notification to
the Authority should not be delayed pending collation of these data.
8.1. Information to be provided as part of the MDRR1 Notification or
Preliminary Report
The dealer conducting the FSCA in Singapore shall ensure that the following
information is provided as part of the FSCA Notification or Preliminary Report
submission to the Authority (not limited to):
Reason for the FSCA
FSCA strategy (if affected stock have been supplied in Singapore)
Product owner’s Health Hazard Assessment (HHA)
Product owner’s Root Cause Analysis (RCA)
Product owner’s CAPA to reduce likelihood of recurrence of device issue
Product owner’s CAPA effectiveness/ validation
Affected device status, including
‐ List of affected consignees, including number of affected units per
local consignee
‐ Quantity manufactured, imported into, or supplied in Singapore.
‐ For manufactured devices that have been exported, list of countries
exported to and quantity of affected units exported shall be provided
to the Authority
Product owner’s FSN or other risk communication documents
A draft ‘Dear Healthcare Professional’ Letter (DHCPL) or print
advertisement (if applicable)
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NOTE: Refer to Section 10.1 for the necessary requirements of FSN submitted to the
Authority during FSCA Report submission.
The RCA should contain important technical information detailing the root
cause and the basis for determination and identification of devices affected by
the FSCA. The CAPA and CAPA effectiveness constitutes important technical
information detailing actions or measures undertaken to satisfactorily address
the root cause behind the FSCA and to support that the likelihood of future
supply being affected by a recurrence of the device defect/ problem/ issue has
been satisfactorily reduced or eliminated. In the interest of public health,
failure on the part of the dealer to promptly provide information on the RCA or
CAPA may necessitate further regulatory actions being undertaken against
the affected devices, including a stoppage to import, supply or use. Hence,
the dealer should ensure that FSCA related information is submitted within
deadlines stipulated in the Authority’s Notices.
In cases where the medical devices affected by the FSCA have not been
supplied in Singapore, this shall be indicated in the FSCA Notification Report
submission.
NOTE: Submission of false or misleading information on FSCA is a serious offence
under the Health Products Act. Dealers shall ensure that all submissions contain complete
and accurate information.
R3.5 ► NOTE: All FSNs of FSCAs reported under MDRR1 must be copied to the
Chairman Medical Board and/ or relevant Head-of-Departments of the affected healthcare
facilities. ◄
Based on the Authority’s risk assessment, the dealer conducting the FSCA
may be instructed by the Authority to perform additional risk control measures.
Such instructions shall be issued through written notice, which includes email.
These measures could include (non-exhaustive list):
Perform an inspection of affected devices supplied in Singapore and to
revert with an inspection report;
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Modify/ amend risk communication on FSCA;
Label existing supplied stock with information specified by the Authority; or
Publish risk communication in specified media.
Failure on the part of the dealer to perform these measures when instructed
by the Authority to do so, would constitute an offence under the Health
Products Act.
8.2. Information to be provided as part of the Final or Follow-Up
Report
A Final or a Follow-up report shall be submitted within 21 days of initiating the
FSCA. If the FSCA has not been completed within 21 days, a Follow-up report
shall be submitted to the Authority within 21 days. The Follow-up report
should provide an update on progress of the reconciliation of stock affected by
the FSCA, together with confirmation that the consignees have received the
FSN. It should also provide a progress report on the investigation to date and
any additional CAPA that is being considered by the product owner.
The dealer conducting the FSCA shall ensure that the following information is
provided as part of the Follow-Up or Final Report submission to the Authority
(non-exhaustive):
Product owner’s CAPA to reduce likelihood of recurrence of device issue
Product owner’s CAPA effectiveness/validation
For recalls, destructions certificates or airway or shipment bill of return of
recalled devices to the product owner
Declaration letter from the dealer on dealer’s letterhead stating the
completion of field correction for affected consignees in Singapore (Refer
to ANNEX 1 for the template of this declaration letter) Note: the
declaration should include all affected devices in warehouse (unsupplied),
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those supplied at the point of FSCA notification and subsequent new
supply of affected devices with FSN, or correction-in-progress devices.
Consignee acknowledgement receipts confirming the receipt of the Field
Safety Notice or DHCPL by the local affected consignees (when
requested)
For FSCAs that require a software upgrade or device modification, service
reports for the completion of the corrective actions specified in the FSN or
other risk communication documents (when requested).
NOTE: Both consignee acknowledgement receipts and service reports shall be
signed-off by the affected consignee, prior to its submission to the Authority when requested.
Unsigned documents shall not be accepted.
NOTE: For supply to overseas consignees, consignee acknowledgement receipts
shall not be required for submission to the Authority. However, the dealer remains responsible
for ensuring that information on the FSCA is disseminated to any overseas consignees.
All FSCA reports are to be submitted using the prescribed format. In some
instances, the Authority may deem that further information is necessary to
assess the adequacy and acceptability of the information provided and
request for it accordingly.
8.3. Information to be provided as part of the MDRR3 Notification
Report
The dealer conducting the FSCA in Singapore shall ensure that the following
information is provided as part of the FSCA Notification Report submission to
the Authority (not limited to):
Product owner’s FSN or other risk communication documents
Quantity imported but not supplied and/or present as stock in warehouse
(if applicable) Note: prior to any supply of these devices, ensure that these
are corrected of the FSCA, conforms to Essential Principles in the R3.2 ►
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GN-16: Guidance on Essential Principles for Safety and Performance of
Medical Devices ◄, and any other applicable regulatory requirements.
The purpose for requesting this information is to verify and confirm that there
has been no manufacture or supply of the affected devices in Singapore.
Furthermore, in the case of registered medical devices, the dealer shall
ascertain whether there is a need for submission of a change notification for
the medical devices corrected for the FSCA. The Authority reserves the right
to request for the submission of information on the FSCA, if deem necessary.
Such information, when requested, shall be submitted within the deadline
stated in the Authority’s written Notice (e.g. email).
8.4. Identification of affected device information in FSN
For FSCA where the affected devices have been manufactured, imported
and/or supplied in Singapore (i.e. MDRR1 report), the FSN can either:
a) provide the complete global list of affected identifiers identified by
product owner; OR
b) only list local affected identifiers in Singapore. In such an instance, a
statement (or any equivalent one) should be included to inform the
recipient or reader of FSN that there may be other affected identifiers
that are affected globally and that they should check with product
owner in the event they obtained the device from an overseas dealer.
For FSCAs where the affected devices have not been supplied in Singapore
(i.e. MDRR3 report), the affected identifiers listed in the FSN should be the
global list.
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9. FSCA INVOLVING CONSUMER-LEVEL MEDICAL DEVICES
In relation to FSCAs involving medical devices that have been supplied at
consumer level (e.g. contact lenses, blood glucose test strips), a draft print
advertisement shall be submitted to the Authority as part of the Notification
Report submission. For consumer-level FSCA, a print advertisement in public
media to the general public is deemed necessary for effective risk
communication to all affected consumers of the FSCA. In general, the
requirement would be to publish in each of the daily newspapers of the four
official languages, unless otherwise allowed by the Authority. In certain cases,
the Authority may also require a press release to be prepared. These
instructions would be stated in the FSCA Acknowledgement Notices.
The contents of the press release and/or print advertisement shall include the
following (non-exhaustive):
Reason for FSCA
Affected product identifier(s)
Pictorial information on how affected products can be identified (in layman
terms)
Information on returns procedure (e.g. to exchange affected units with
non-affected stock)
Dealer contact hotline (including operating hours) and email address for
enquiries
All consumer-level risk communications shall require prior clearance from the
Authority. Consumer-level FSCAs are highly time-sensitive and require urgent
actions to be undertaken. Dealers are expected to conduct such FSCAs
expediently and effectively.
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10. FSCA INVOLVING IMPLANTABLE MEDICAL DEVICES
For FSCAs involving implantable medical devices, dealers shall be required to
prepare a ‘Dear Healthcare Professional’ Letter (DHCPL) for dissemination to
qualified practitioners who have been supplied or performed implantations
using the devices affected by the FSCA. The DHCPL shall contain information
on the product owner’s clinical management advice to qualified practitioners
with regards to patients who have been implanted with medical devices
affected by the FSCA.
The DHCPL shall only be disseminated upon receipt of written clearance from
the Authority. Nevertheless, in the interim, the dealer should still inform all
affected consignees of the FSCA through product owner’s FSN, while
changes to the DHCPL are being finalised.
NOTE: For guidance on drafting a DHCPL, please refer to GN-09: Guidance on the
Component Elements of a DHCPL.
Dealers shall be required to report the number of implantations that had been
performed in Singapore using the affected medical devices that had been
supplied by them.
All qualified practitioners who have been supplied or performed the
implantation using the devices affected by the FSCA shall receive a copy of
the DHCPL from the dealer. The acknowledgement receipt of DHCPL is
intended to be signed by the said qualified practitioner. In cases where the
qualified practitioner has left his practice, the facility where the implantation
occurred shall acknowledge receipt of the DHCPL on behalf of the qualified
practitioner. Other recipients of the DHCPL should include the procurement
department of the healthcare facility.
NOTE: Acknowledgement of the DHCPL constitutes a confirmation that the qualified
practitioner involved has received a copy of the DHCPL or other risk communication
associated with the FSCA. This is a form of effectiveness check that the Authority performs.
FSN acknowledgement receipts will not be requested by The Authority for cases where
DHCPL is required.
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11. RISK MANAGEMENT PROCESS FOR SUPPLY OF MEDICAL
DEVICES.
Medical devices that are affected by the FSCA are determined from the
product owner’s FSN. In general, supply of medical devices that are affected
by a FSCA, and that have not been corrected, is not permitted. Medical
devices that are not affected by the FSCA can continue to be supplied subject
to standard regulatory requirements being continued to be satisfied.
Based on the corrective action intended by product owner, FSCAs can be
divided into two categories: (1) recalls, and (2) other corrective actions.
For recalls, by default, new supply of medical devices affected by the recall is
not permitted. Once affected devices have been recalled from the field, the
dealer shall ensure that the recalled devices are quarantined / disposed and
not permitted for further supply.
For other corrective actions, there are two main sub-categories: (1)
corrections limited to labelling, and (2) corrections not limited to labelling.
For other corrective actions that are limited to labelling (e.g. advice given by
product owner on device precaution or addition of user warning), new supply
of affected device may be permitted with the condition that supply of affected
device is accompanied by the product owner’s FSN.
NOTE: For any FSCA, including those where correction is limited to labelling, Authority
reserves its right to instruct additional measures where it deems necessary.
NOTE: For avoidance of doubt, when determining whether a FSCA is limited to labelling
changes, changes in indication or shelf life would be deemed as corrections that are not
solely limited to labelling.
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HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 23 of 29
For other corrective actions that are not limited to labelling, there are two
further sub-categories: (1) correction-in-progress devices, and (2) corrected
devices.
For corrected medical devices, supply may proceed, subject to standard
applicable regulatory requirement such as change notification (CN). For
further information on the types of changes to registered medical devices that
require CN, please refer to GN-21: Guidance on Change Notification. Failure
to notify and/or obtain approval from the Authority of changes made to
registered medical devices is an offence under the Health Products Act.
For correction-in-progress medical devices, whether the product owner’s
interim risk mitigation measures are sufficient is the main consideration in
relation to new supply. If the dealer and product owner substantiates to the
Authority that the interim risk mitigation measures are sufficient, and the
Authority concurs with the product owner’s justification, new supply of
correction-in-progress medical devices may be permitted, subject to
conditions. Examples of conditions that may be issued include (but not limited
to), ensuring correction-in-progress medical devices that were supplied
undergo full correction upon availability of final CAPA, FSN to be provided
with each supply, and a declaration to confirm that full correction for all
correction-in-progress medical devices has been completed.
Refer to Annex 2 for illustration on the risk management process for new
supply of medical devices.
NOTE: The Authority’s Notice would include instructions regarding supply of
correction-in-progress medical devices. Non-compliance to this Notice would constitute a
serious offence under the Health Products Act.
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HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 24 of 29
12. COMPLIANCE TO NOTICES
Pursuant to Regulations 46(4) of the Health Products (Medical Devices)
Regulations 2010, non-compliance to notices issued by the Authority would
constitute a serious offence. Penalties that apply for failure to perform the
measures required under notices issued by the Authority are a fine not
exceeding $10,000 or to imprisonment for a term not exceeding 6 months, or
to both.
13. PUBLICATION OF FIELD SAFETY NOTICES ON HSA WEBSITE
Safety communications of FSCAs reported to the Authority are publicly
accessible as field safety notices (FSN) on the HSA website. Accessibility to
safety information regarding medical devices will facilitate timely identification
and management of risks posed by medical devices affected by FSCAs.
Please note that FSNs are issued by the product owner or dealer of medical
devices pursuant to the requirements under the Health Products Act (Cap.
122D). These persons take full responsibility for all information contained in
the FSN.
Consignees who receive a FSN from a product owner or dealer must always
act on it. The Authority makes FSNs publicly available for information only.
For any specific questions on a FSN, consignees have been advised to
contact the product owner or dealer (as the case may be).
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13.1. FSN Requirements for Publication
The FSN for publication should:
be submitted as a single Adobe PDF document instead of a Microsoft
Word document;
not be tagged as “Draft”;
not include or add information that has not been authorised by the
product owner or the Authority;
not have information regarding the FSCA deleted, altered or concealed
from;
not be password-protected;
not contain any third party marks (e.g. contact details of consignees);
and
be accessible to any person who may have potentially been supplied
with affected devices. Therefore, the presence of “Privileged and
Confidential” or “Restricted” tags in the FSN is inappropriate and
strongly discouraged.
NOTE: The publication of FSN is to ensure FSCA related safety information is
accessible to any party who may have received affected medical devices so as to safeguard
public health.
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14. COMPLETION OF REPORTING OBLIGATIONS FOR FSCA
The FSCA reporting obligation will be considered completed when all
appropriate corrective actions have been undertaken by the dealer, subject to
the concurrence of the Authority. The FSCA reporting obligation is only
considered completed upon receipt of written confirmation from the Authority.
The dealer should maintain records related to the FSCA for a minimum period
of either 2 years or the projected useful life of the medical devices, whichever
is longer. Such records should include, inter alia, the FSN, list of affected
consignees, acknowledgement receipts for dissemination of FSN or DHCPL,
or service reports documenting device corrections performed.
Although the FSCA is deemed completed, the Authority reserves its right to
request for additional information in related to the FSCA when necessary.
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ANNEX 1
Declaration Template
[To be printed on dealer Letterhead of dealer]
Medical Devices Branch
Medical Devices Cluster
Health Products Regulation Group
Health Sciences Authority
[Date]
Dear Sir/Madam,
Subject: Declaration on completion of correction for Field Safety Corrective Action
Ref No. <HSA FSCA Ref No. HSA 600:41:01-xxx/yy/xx>
1. We, [name of dealer], hereby declare that the list of consignees in Singapore
supplied with medical device affected by FSCA, <HSA FSCA Ref No.>, are limited to:
Consignee Name
Quantity
Status of
correction of
affected device
<Consignee 1, provide full name of e.g.
clinic or hospital>
<completed>
<Consignee 2, provide full name of e.g.
clinic or hospital>
2. We confirm that we have provided to all affected consignees in Singapore,
listed in paragraph 1, a copy of the Field Safety Notice (FSN), and have completed
all corrections required to complete the aforementioned FSCA.
3. Written acknowledgements confirming full and effective completion of the field
corrections required as per product owner’s FSN have been collected from
consignees listed in paragraph 1. Records of acknowledgement receipts will be
provided to HSA when requested.
4. We attest the information submitted as part of this declaration has been
verified to be true and accurate, and are aware of the penalties that apply under the
Health Products Act and its subsidiary legislation for false or misleading submissions.
Yours Sincerely,
[Signature]
[Full Name and Title]
[Name and address of company]
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ANNEX 2
Risk Management Process for New Supply of Medical Devices (MD)
FSCA
MDRR1
MDRR3
Dealer notifies HSA
and submits
declaration
No supply of defective
MDs. FSCA reporting
obligation is completed.
Recall
s
Correction limited to
labelling (exclude
indications or shelf
life change)
Correction not limited
to labelling (all other
physical device
corrections, including
software upgrade)
New supply of
correction-in-progress
MD is allowed, subject
to conditions.
New supply with
FSN is allowed
Correction-in-
progress MD
Corrected MD
HSA’s
acknowledgment
notice (key
consideration: PO’s
interim risk mitigation
deemed sufficient?)
New supply of
correction-in-progress
MD is not allowed.
Yes
No
New supply of corrected
MD is allowed, subject to
standard applicable
regulatory requirements
e.g. CN
New supply is
not allowed
Affected MD
Not affected MD
New supply is
allowed
Other corrective
actions
Affected MD
Contact Information:
Medical Devices Branch
Medical Devices Cluster
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-03 Helios
Singapore 138667
www.hsa.gov.sg
https://crm.hsa.gov.sg/event/feedback