medical device industry briefing - hsa · medical device industry briefing - hsa ... marketing
TRANSCRIPT
1 © Copyright 2012, Health Sciences Authority.
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Enhancements to Change Notification
for Class A and B Medical Devices
November 2012
Medical Device Branch
Health Products Regulation Group
Health Sciences Authority
Medical Device Industry Briefing
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Introduction
Changes not qualifying as Change Notification
Minor Administrative Change Notification (MAC) for all
risk classes
NEW Change Notification Routes for Class A and B
Medical Devices
Changes that would not affect the SMDR device listing
(CN1)
Changes that would affect the SMDR device listing
(CN2)
Case Studies
MEDICS Submission of Change Notification
Application
Scope
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• To update the authority of any change to the registered
specification of the registered medical devices (MD)
Inputs
• Materials
• Components
• New Technologies
Process
• Design
• Manufacture
Finished Product
• Product Owner
• Name
• Label Color
• Font size
Examples of changes to a registered MD:
Why Change Notification?
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Changes that require New Pre-market Application
• Change to intended purpose
• Change to the risk classification of a device
• Addition of variant(s) not considered a permissible variant
• Change of medicinal substance in a device incorporating
medicinal product
Changes NOT qualifying as Change
Notification
Other Changes
• Change of Registrant (GN-24)
• Cancellation of medical device listing (GN-25)
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• Applicable to all risk classes of registered medical
devices (Class A to D)
• Minor Administrative Change Notification could be
implemented upon successful submission of the MAC
Notification application to HSA
• No fees are payable for this route of submission and
SMDR listing will be updated accordingly if required.
Minor Administrative Change Notification
(MAC)
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Category of
Change
Type of Change
Labels including
Instructions for
Use (IFU)
Layout
Colour
Font size and design
Addition and/or removal of languages not required by HSA
Addition of reference agencies’ approvals Eg: CE marking
Software
version
Changes to software version number that are not due to
changes affecting safety, quality or effectiveness of the
medical device, such as:
a) Software changes solely to correct an inadvertent software
error which does not add new functions, does not pose any
safety risks and is intended to bring the system to
specification
Minor Administrative Change Notification
(MAC)
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Category of
Change
Type of Change
Software version b) Software changes which augment interfacing to
other non-medical peripherals such as printers
or VDUs and which has no diagnostic or
therapeutic function
c) Software changes which only modify the
appearance of the user interface with no risk to
diagnostic or therapeutic function of the device
Changes in
package size
Changes which increase or reduce the number of
devices in a pack of the device
Model Listing –
Deletion only
Reduction in the number of models listed e.g. due
to obsolescence or line rationalisation
Certificates Update of validity dates to QMS documents such as
ISO 13485
Minor Administrative Change Notification
(MAC)
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• Summary Table of Change Notification [Annex 2 for CN,
GN-21]
• Updated certificates, if applicable
• Updated labels including IFU, if applicable. Changes
should be clearly redlined/tracked.
Submission requirement for MAC
Successful
Submission of
CN application
via MEDICS
Verification of
documents
Registrant
implements
the changes
Processing of applications
Minor Administrative Change Notification
(MAC)
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Overview of Change Notification Routes for
Class B Medical Devices
Changes other than MAC to be submitted through the following routes
Changes Authorised for marketing in Reference Agencies
• CN1 Route (Changes that do not affect the device listing)
• CN2 Route (Changes that affect the device listing)
Changes NOT Authorised for marketing in Reference Agencies
• CN Route (as current GN-21)
New Routes for CN are not applicable if the medical device is a subject of an
open FSCA.
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Change Notification Routes for Registered
Class B Medical Devices
Proposed Changes to
Medical Device
(Class B)
Does the change qualify
as Minor Administrative
Change?
Is the change
authorised for marketing
in Reference Agency?
Does change affect
device listing?
a) Submit a Minor
Administrative
Change
Notification
b) Immediate supply
c) No fees
a) Submit the CN based on
current GN-21 requirements – CN
Route
b) Fees:
$500 (Application Fees)
$600 (Evaluation Fees)
a) Submit as CN1
b) Immediate supply
c) Fees: TBD
a) Submit as CN2
b) Approval required before
supply
c) Fees: TBD
YES
YES
NO YES
NO
NO
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Regulatory decision
and update of SMDR
for proposed changes
(if applicable)
Verification
and review of
application
Submission of
CN application
via MEDICS
• Checklist of Supporting documents (Annex 1: only require the
relevant sections)
• Summary Table of Change Notifications (Annex 2),
• All supporting documents.
• The relevant section(s) of Common Submission Dossier
Template (CSDT) information; where applicable, and when
requested
Submission requirement
Processing of applications
CN-Route (GN-21)
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Change Notification Routes for Registered
Class B Medical Devices
Proposed Changes to
Medical Device
(Class B)
Does the change qualify
as Minor Administrative
Change?
Is the change
authorised for marketing
in Reference Agency?
Does change affect
device listing?
a) Submit a Minor
Administrative
Change
Notification
b) Immediate supply
c) No fees
a) Submit the CN based on
current GN-21 requirements – CN
Route
b) Fees:
$500 (Application Fees)
$600 (Evaluation Fees)
a) Submit as CN1
b) Immediate supply
c) Fees: TBD
a) Submit as CN2
b) Approval required before
supply
c) Fees: TBD
YES
YES
NO YES
NO
NO
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CN2-Route
Successful
Submission of
CN application
via MEDICS
Regulatory decision
and update of SMDR
for proposed
changes
Verification
and review of
application
Processing of applications
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• Manufacturing facility, process,
quality control
• Manufacturing facility
• Sterilization method
• Sterilization process
• Design or performance
specifications
• Changes in materials (General
MD)
• Changes in materials (IVD)
• Changes in labeling
• Indications for use
• Contraindications/warnings/pre
cautions
• Expiry duration, shelf life and
storage conditions
• Other labeling changes
• Other changes
• Addition of a new product within a
grouped Device Listing
• Change to product name only
• Change in product owner, including
product name and address
• Addition of a new product within a
grouped Device Listing (package
size)
• Deletion of product within a grouped
registration
• Change in regulatory status in
reference agencies
• Update of regulatory approval
certificates from reference agencies
Changes identified in boxes affect the device
listing
Changes that would affect the device listing
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• Manufacturing facility
• Sterilization method
• Product owner (including Product Owners’ details)
• Product name (including product Identifier)
• Addition of new product to device listing
• Indications for use
Changes that would affect the device listing
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Changes to the manufacturing facility include changes to
• Outsourced sterilisation facilities
• manufacturing facility name
• changes to quality management certificate and
• changes to manufacturing facility address
Manufacturing facility
Submission requirements include:
• Quality Management System certificate(s)
• Device labelling, if applicable
• Validation studies from new site, if applicable
• Declaration that the proposed changes are authorised for
marketing in HSA’s Medical Device Reference Agency(s)
• Declaration that the medical device is not a subject of an open
field safety corrective action
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• Manufacturing facility
• Sterilisation method
• Product owner (including Product Owners’ details)
• Product name (including Product Identifier)
• Addition of new product to device listing
• Indications for use
Changes that would affect the device listing
ADDENDUM A
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• Manufacturing facility
• Sterilization method
• Product owner (including Product Owners’ details)
• Product name (including product Identifier)
• Addition of new product to device listing
• Indications for use
Changes that would affect the SMDR device listing
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Changes to the legal Product Owner’s identity, including the Product Owner’s
name and address
Product owner
(including Product Owners’ details)
Submission requirements include:
• Letter of authorisation (LOA) from new Product Owner
• Quality management system (QMS) certificate(s) (If applicable)
• Regulatory approval certificate(s) (If applicable)
• Device labelling (if applicable)
• Declaration of conformity (DOC) document from new Product Owner
• Declaration from new Product Owner for the post-market responsibility of
products already supplied under the former product owner’s name (If
applicable)
• Declaration that the proposed changes are authorised for marketing in the
HSA’s Medical Device Reference Agency(s)
• Declaration that the medical device is not a subject of an open field safety
corrective action
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• Manufacturing facility
• Sterilization method
• Product owner (including Product Owners’ details)
• Product name (including product Identifier)
• Addition of new product to device listing
• Indications for use
Changes that would affect the SMDR device listing
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Changes to the product name only, including the product “Identifier”
which uniquely identifies the device
Product Name
(including Product Identifier)
Submission requirements include:
• Letter of authorisation (LOA) from Product Owner
• Device labelling (if applicable)
• Declaration from Product Owner on the change in product name
• Declaration that the proposed changes are authorised for
marketing in the HSA’s Medical Device Reference Agency(s)
• Declaration that the medical device is not a subject of an open
field safety corrective action
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• Manufacturing facility
• Sterilization method
• Product owner (including Product Owners’ details)
• Product name (including product Identifier)
• Addition of new product to device listing
• Indications for use
Changes that would affect the SMDR device listing
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Addition of a new product to an existing SMDR device listing
MUST fulfil the FAMILY, SYSTEM, GROUP or TEST KIT
requirement as set out in GN-12: and must have same
proprietary name in order to be added to the listing.
Addition of new product
to device listing
Submission requirements include:
• The CSDT information for ALL applicable sections for Class B
devices and relevant to the new model being added.
• Annex 2 for GN-17 and GN-18: List of Configurations of Medical
Devices to be Registered
• Justification for addition of product(s) to be grouped within the
registered Product
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Addition of new product
to device listing
Submission requirements include (con’t):
• Regulatory approval documents from the reference agencies
• Device Information
• Device labelling for new product(s)
• Declaration of conformity document
• Letter of authorisation (LOA) from Product Owner
• Declaration that the proposed changes are authorised for
marketing in the HSA’s Medical Device Reference Agency(s)
• Declaration that the medical device is not a subject of an open
field safety corrective action
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• Manufacturing facility
• Sterilization method
• Product owner (including Product Owners’ details)
• Product name (including product Identifier)
• Addition of new product to device listing
• Indications for use
Changes that would affect the SMDR device listing
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Indications for use is a general description of the disease or condition that the
medical device will diagnose, treat, prevent, cure or mitigate and includes a
description of the target patient population for which the medical device is
intended.
Indications for use
(Expansion or Reduction)
Submission requirements include:
• The relevant sections of the CSDT
• Updated device labelling for new product(s), including IFU
• Declaration of conformity document
• Declaration that the proposed changes are authorised for marketing in
the HSA’s Medical Device Reference Agency(s)
• Declaration that the medical device is not a subject of an open field
safety corrective action
• Reason for the reduction of the approved indications (for reduction of
indications for use only)
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Change Notification Routes for Registered
Class B Medical Devices
Proposed Changes to
Medical Device
(Class B)
Does the change qualify
as Minor Administrative
Change?
Is the change
authorised for marketing
in Reference Agency?
Does change affect
device listing?
a) Submit a Minor
Administrative
Change
Notification
b) Immediate supply
c) No fees
a) Submit the CN based on
current GN-21 requirements – CN
Route
b) Fees:
$500 (Application Fees)
$600 (Evaluation Fees)
a) Submit as CN1
b) Immediate supply
c) Fees: TBD
a) Submit as CN2
b) Approval required before
supply
c) Fees: TBD
YES
YES
NO YES
NO
NO
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CN 1 Route
Submission requirement
• Summary Table of Change Notification [Annex 2 for CN, GN-21]
• Updated labels including IFU, if applicable
• Declaration that the proposed changes are authorised for
marketing in HSA’s Medical Device Reference Agency(s)
• Declaration that the medical device is not subject of an open field
safety corrective action (Annex A)
Processing of applications
Successful
Submission of
CN application
via MEDICS
Verification of
documents
Registrant
implements
the changes
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• Email notification of approval will be sent within 48
hours (on weekdays) upon successful submission
– Note that this is applicable only for change notification
applications solely with CN1 changes submitted via CN1
Route
– In the event, that CN1 changes are submitted together with
CN2 or CN changes in MEDICS under the CN2 or CN Route,
the supply of the changed device will be subject to the
approval of the change notification application
• If the device does not qualify for CN1 Route then
Registrant will have to resubmit via CN2 or CN Route
CN 1 Route ADDENDUM B
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Overview of Change Notification Routes for
Class A Medical Devices
Changes other than MAC to be submitted through the following routes
Changes Authorised for marketing in Reference Agencies
• CN1 Route (Changes that do not affect the device listing)
• CN Route (Changes that affect the device listing; as current GN-21)
Changes NOT Authorised for marketing in Reference Agencies
• CN Route (as current GN-21)
New Routes for CN are not applicable if the medical device is a subject of an
open FSCA.
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Change Notification Routes for Registered
Class A Medical Devices
Proposed Changes to
Medical Device
(Class A)
Does the change qualify
as Minor Administrative
Change?
Is the change
authorised for marketing
in Reference Agency?
Does change affect
device listing?
a) Submit a Minor
Administrative
Change Notification
b) Immediate supply
c) No fees
a) Submit the CN based on current
GN-21 requirements – CN
Route
b) Fees: $25 a) Submit as CN1
b) Immediate supply
c) Fees: TBD
YES
YES
YES NO
NO
NO
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Minor Administrative
Change - MAC
(Existing)
Change Notification 1
Route – CN1
(NEW)
Change Notification 2
Route – CN2
(NEW)
Change Notification
Route
(Existing
as per GN-21)
Applicable to all risk
class of medical devices
(Class A-D)
Applicable to Class A&B Applicable for Class B
only
Applicable to all risk
class of medical devices
(Class A-D)
Closed list of categorical
changes (Table 1)
Changes proposed are
authorized for marketing
in at least one of HSA’s
reference agencies for
intended use identical to
that intended for
marketing in Singapore
Changes proposed are
authorized for marketing
in at least one of HSA’s
reference agencies for
intended use identical to
that intended for
marketing in Singapore
All changes and
proposed changes to a
Class A or B medical
device that are NOT
eligible for marketing in
any of HSA’s reference
agencies.
Administrative or
technical change would
apply.
Changes that may or
may not affect the
device listing
Changes that do not
affect the device listing
Changes that affect the
device listing
Changes that may or
may not affect the
device listing
Not applicable
The medical device is
not subject of an open
field safety corrective
action
The medical device is
not subject of an open
field safety corrective
action
Not applicable
Eligibility Criteria for CN routes
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Eligibility Criteria for CN routes Minor Administrative
Change - MAC
(Existing)
Change Notification 1
Route – CN1
(NEW)
Change Notification 2
Route – CN2
(NEW)
Change Notification
Route
(Existing
as per GN-21)
Applicable to all risk
class of medical devices
(Class A-D)
Applicable to Class A&B Applicable for Class B
only
Applicable to all risk
class of medical devices
(Class A-D)
Closed list of categorical
changes (Table 1)
Changes proposed are
authorized for marketing
in at least one of HSA’s
reference agencies for
intended use identical to
that intended for
marketing in Singapore
Changes proposed are
authorized for marketing
in at least one of HSA’s
reference agencies for
intended use identical to
that intended for
marketing in Singapore
All changes and
proposed changes to a
Class A or B medical
device that are NOT
eligible for marketing in
any of HSA’s reference
agencies.
Administrative or
technical change would
apply.
Changes that may or
may not affect the
device listing
Changes that do not
affect the device listing
Changes that affect the
device listing
Changes that may or
may not affect the
device listing
Not applicable
The medical device is
not subject of an open
field safety corrective
action
The medical device is
not subject of an open
field safety corrective
action
Not applicable
MAC CN1 CN2 CN(GN-21)
Increasing level of stringency
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Case Studies
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Case Study 1: Software Change
The following changes were made:
1) Software update which affects the color coding of a visual display on ECG
monitor, without any additional information/decisional change
1. Is this a minor administrative change?
Yes
2. Is the change authorised for marketing in Reference Agency?
N.A
3. Does change affect device listing?
N.A
Change qualifies for MAC
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2) Addition of an early warning alarm to signal potential cardiac event
1. Is this a minor administrative change?
No.
2. Is the change authorised for marketing in Reference Agency?
No.
3. Does change affect device listing?
N.A
Change qualifies for CN Route- GN-21
(Technical Change)
Case Study 1: Software Change
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Can the following changes be submitted as 1 change notification
application?
1) Software update which affects the color coding of a visual display on
ECG monitor, without any additional information/decisional change
MAC
2) Addition of an early warning alarm to signal potential cardiac event
CN (Technical)
MAC CN1 CN2 CN(GN-21)
Yes, 1 application
CN Route (Technical) applies
Case Study 1: Software Change
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One Dossier vs Across Dossier
DE001
• Model A
• Model B
• Model C
DE002 • Model D
• Model E
DE003
• Model F
• Model G
• Model H
• Model I
DE001
• Model A
• Model B
• Model C
DE002 • Model B
• Model E
DE003
• Model B
• Model H
• Model I
1 dossier
(Multiple listing)
Multiple dossiers
(Identical change)
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The following changes were made:
- Change in material of the same transfusion tubing that were included in
the different dossiers (C-12346, C-12347 and C-12348)
i.e. Identical change across dossiers:
Same tubing is in DE0004, DE0005 and DE0006
DE0004 DE0005 DE0006
C-12346
Case Study 2: Transfusion Sets
(Across Dossier)
HSA Yen
Transfusion Set :
- Needle
- Transfusion
tubing
- Connectors
- Clamps
HSA Ven
Transfusion Set :
- Needle
- Transfusion
tubing
- Connectors
- Clamps
HSA Ren
Transfusion Set :
- Needle
- Transfusion
tubing
- Connectors
- Clamps
C-12347 C-12348
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1. Is this a minor administrative change?
No.
2. Is the change authorised for marketing in Reference Agency?
Yes.
3. Does change affect device listing?
No.
Change qualifies for CN1
DE0004 DE0005 DE0006
C-12346
Case Study 2: Transfusion Sets
(Across Dossier)
HSA Yen
Transfusion Set :
- Needle
- Transfusion
tubing
- Connectors
- Clamps
HSA Ven
Transfusion Set :
- Needle
- Transfusion
tubing
- Connectors
- Clamps
HSA Ren
Transfusion Set :
- Needle
- Transfusion
tubing
- Connectors
- Clamps
C-12347 C-12348
1) Change in material of tubing (C-12346, C-12347 and C-12348)
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ANNEX 2 of Change Notification for Class A and B Medical Devices
The medical device in this Change Notification application is not a subject of an
open field safety corrective action. Yes No
Type of Changes (according
to Annex 1) [Does this
change qualify for MAC,
CN1 or CN2 ?]
Present Proposed Reason for change Status of proposed
change in
reference agencies
Change in material:
Transfusion tubing material
changed from polyvinyl
chloride (PVC) to silicone
[Change Qualify for CN1]
(Same tubing is in all the
SMDR Device listing below )
SMDR Device listing no(s):
(i) DE0004
(ii) DE0005
(iii) DE0006
Transfusion
tubing
material:
polyvinyl
chloride
(PVC)
Transfusion
tubing
material:
silicone
Improve patient
safety by changing
to DEHP-free tubing
material
Australia TGA –
pending
EU Notified Body –
authorised for
marketing
Health Canada –
not supplied
US FDA – not
supplied
Japan MHLW – not
supplied
Case Study 2: Transfusion Sets
(Across Dossier)
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Case Study 3: Vital Signs Monitoring
Equipments
The following changes were made
1) Change in the product owner name from “HSA” to “MDB”
2) Change of material of ECG electrode (DE001)
MAC CN1 CN2 CN(GN-21)
HSA Zen Portable
ECG
-ECG
- Electrodes
HSA Zen Pulse Oximeter
- Oximeter
- Sensors
DE001 DE002
C-12345 C-12346
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HSA Zen Portable
ECG
-ECG
- Electrodes
HSA Zen Pulse
Oximeter
- Oximeter
- Sensors DE001 DE002
1) Change in the product owner name from “HSA” to “MDB”
1. Is this a minor administrative change?
No.
2. Is the change authorised for marketing in Reference Agency?
Yes.
3. Does change affect device listing?
Yes.
Change qualifies for CN2
MDB Zen Portable
ECG
-ECG
- Electrodes
MDB Zen Pulse
Oximeter
- Oximeter
- Sensors DE001 DE002
Case Study 3: Vital Signs Monitoring
Equipments
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2) Change of material of ECG electrode (DE001)
1. Is this a minor administrative change?
No.
2. Is the change authorised for marketing in Reference Agency?
Yes.
3. Does change affect device listing?
No.
Change qualifies for CN1
Case Study 3: Vital Signs Monitoring
Equipments
Can the following changes be submitted as 1 change notification
application?
1) Change in the product owner name from “HSA” to “MDB”
2) Change of material of ECG electrode (DE001)
No. Not identical change across dossiers.
2 separate submissions required.
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Case Study 3: Vital Signs
Monitoring Equipments
2 separate submissions required:
1. CN2 Route application for change in product owner
name to DE002
2. CN2 Route application for change in product owner
name (CN2) and change in material of ECG electrode
(CN1) to DE001
ADDENDUM C
All changes (CN1 and CN2) in this application
shall be implemented only upon approval in
MEDICS.
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MEDICS Submission of Change Notification
Application
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Change Notification Application (Lower
Risk Class – Class A)
Direct link:
http://www.hsa.gov.sg/publish/hsaportal/en/services/medics/amendment.html
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1. Access the amend@medics e-Service from HSA website. After logging in
and accepting terms and conditions, the following screen will appear.
2. Retrieve the Low Risk Medical Device you wishes to submit a Change
Notification for.
3. Click on the Registration No. URL.
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The Main Change Notification for Low Risk Device Form will appear with the
new section 2 Change Notification.
4. Fill in all mandatory fields in section 1 Applicant Info.
5. Click on Add/Edit Info under section 2 to select the Types of Changes
Main Page
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6. Select the applicable types of changes and click Update Form. The Main Form
will appear again
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7. Click on Edit Info under section 3 Device Info
Main Page
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8. Modify the information accordingly and click Update Form. The Main Form
will appear again
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9. Click on Edit Info under section 4 Product Owner Info
Main Page
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10. Modify the information accordingly and click Update Form. The Main Form
will appear again
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11. Click on Add/Edit Info under section 5 Manufacturing Site(s) Info
Main Page
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12. Modify the information accordingly and click Update Form. The Main Form
will appear again
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13. Click on Add/Edit Info under section 6 Model(s) Info
Main Page
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14. Modify the information accordingly and click Update Form. The Main
Form will appear again
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15. Click on Attach/Remove Document(s) under section 9 Supporting
Document(s). A prompt will appear.
20. Click OK
Main Page
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16. For each Document Type, click Browse to select the file to be uploaded
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17. Click the upload file button to start uploading the selected file
18. For the Quality Management System, select the applicable option. The
Browse button is only enabled for the selected option
Select an expiry date for the selected option
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19. Click Browse under the selected option to select the file to be uploaded
20. Click the upload file button to start uploading the selected file
21. After uploading all required documents, click Attach. The Main Form will
appear again.
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22. Enter Remarks for MDB if any.
23. Check the declaration checkboxes
24. Click Confirm. The Confirmation page will appear
Main Page
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25. The Submit button is only enabled when the Declarations are accepted.
26. Click Submit. Payment Advice page will appear.
27. Proceed to make payment according to submit the application
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Change Notification Application (Higher
Risk Class – Class B)
Direct link:
http://www.hsa.gov.sg/publish/hsaportal/en/services/medics/supplementary_a
pplication.html
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1. Access the Change Notification for High-risk Devices e-Service from HSA
website. After logging in and accepting terms and conditions, the following
screen will appear.
2. Fill in all mandatory fields in section 1 Applicant Info.
Main Page
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3. Click on Add/Edit Info under section 2 to select the Types of Changes
Main Page
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4. Select the applicable types of changes and click Update Form. The Main
Form will appear again
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MAC
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MAC
When submitting MAC changes together with other
changes, registrants are required to identify and
select the MAC change in the MEDICS system, in
addition to identifying the overall route of the
application based on stringency (i.e. CN1, CN2 or
CN)
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Main Page
5. Click on Edit Info under section 3 Affected Device Listing
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6. Select the affected devices and click Add
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7. Click Update Form. The Main Form will appear again
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Main Page
8. Click on Attach/Remove Document(s) under section 4 Supporting Document(s).
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9. Select the Device Listing you wish to upload document
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10. Click Browse to select the file you wish to upload for each required document
type
11. Click Add Attachment start uploading the selected file(s)
12. After uploading all required documents, click Update Form. The Main Form will
appear again.
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13. Enter Remarks for MDB if any.
Main Page
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14. Click Confirm. A prompt will pop up to remind the applicant to submit all
changes collectively.
15. Click OK.
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The Confirmation page will appear. The Submit button is only enabled when the
Declarations are accepted
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16. Click Submit. Payment Advice page will appear.
17. Proceed to make payment according to submit the application