ANNEX 1 to GN-21: Change Notification Checklist
This checklist is provided to assist the Registrant in determining the required documents for types of changes proposed. Submission of this
checklist in MEDICS is mandatory.
NOTE:
All the required documents must be submitted for the relevant sections of the CSDT to support the proposed changes to the device. The
documentary requirements in this checklist are meant to cover the broadest aspect for each category of change. If any required documents as
defined in the respective category in this checklist are not available or applicable for the change proposed, please provide a clarification or
justification as appropriate.
Please also refer to GN-15 for the relevant templates/documents which may be required for the registered devices.
Provided?
Type of Change
Documentary Requirements
Yes
All category of changes
Completed
Annex
1
to
GN-21:
Change
Notification Checklist
Completed Annex 2 to GN-21:
Summary
Table of Change Notification (As per Annex 2
to this guidance document)
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Completed Annex 3 to GN-21: Medical Device
Safety and Performance Declaration
(As per Annex 3 to this guidance document)1
1A
Quality Management System certificate(s)
All changes to manufacturing and/or sterilisation
facilities with no changes to the manufacturing
and/or sterilisation processes.
Device labelling with changes redlined and
annotated beside each amended section
(if applicable)
Declaration letter from Product Owner on
company letterhead stating that there is no
change
to
existing
manufacturing
sterilisation process
Sterilization validation report
(if applicable)
1
Except changes implemented as a result of reportable AE/ FSCA
and
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
If no, please provide justification
For changes in manufacturing/ sterilization site of medical devices containing medicinal products in
an ancillary role, please contact the Medical Device Branch, Health Sciences Authority for further
advice.
1B
Quality Management System certificate(s)
All changes to manufacturing processes (including
changes made to outsourced processes) that result
in a change in
medical device
specifications of a registered
Device labelling with changes redlined and
annotated beside each amended section
(if applicable)
Summary of new manufacturing process
Validation studies covering new processes
Pre-clinical studies
Software validation report (For software only)
Clinical studies (For operating principles and
design characteristics change)
(if applicable)
Risk analysis
Provided?
Type of Change
Documentary Requirements
Yes
If no, please provide justification
For changes in manufacturing/ sterilization site of medical devices containing medicinal products in
an ancillary role, please contact the Medical Device Branch, Health Sciences Authority for further
advice.
1C
Sterilisation technique
All changes to sterilisation processes (including
changes made to outsourced processes)
Device labelling with changes redlined and
annotated beside each amended section
(if applicable)
Sterilization validation report (including the
Sterilisation Protocol, Sterilisation Standards
applied. Sterility Assurance Level, Sterilisation
Revalidation report)
Quality Management System certificate(s)
Post Sterilisation functional test report
1D
Updated
All changes to Quality Management System (QMS)
Certificate(s)
Quality
Management
System
Provided?
Type of Change
Documentary Requirements
Yes
certificate(s) for manufacturing and sterilisation
Device labelling with changes redlined and
facilities
annotated beside each amended section
(if applicable)
Reason for cancellation of QMS certificate
(if applicable)
2A
Pre-clinical studies
All changes to the control mechanisms, operating
principles
and/or
design
registered medical device
characteristics
of
a
Risk analysis
Clinical studies
(if applicable)
Device labelling with changes redlined and
annotated beside each amended section
Software validation report (For software only)
Detailed summary of software changes
(For software only)
2B
Pre-clinical studies
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
All changes in specifications of a registered
Clinical studies
medical device
(if applicable)
Risk analysis
Device labelling with changes redlined and
annotated beside each amended section
Software validation report (For software only)
Detailed summary of software changes
(For software only)
3A
Pre-clinical studies
All changes to biological materials that involve a
change in type, source, processing and/or supplier
of cells, tissues, and/or derivatives of animal,
human, microbial or recombinant origin without a
Clinical studies
(if applicable)
Biological safety data
change in the intended purpose of the biological
material
Information of sources/donors
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
3B
List of materials making direct/ indirect contact
All changes to materials or material formulation (of
with human body
If no, please provide justification
non-biological origin) including changes to device
coating or surface modification techniques, that
make direct/indirect contact with body tissues and
Pre-clinical studies
fluids, or is absorbed by the body
3C
Information on radiation source
All changes to materials that are used for shielding
Information on materials for shielding of
in medical devices emitting ionising radiation
radiation
3E
All changes to concentration or drug specifications
(DS) of medicinal substances in medical devices
that incorporate medicinal substances
Contact the Medical Device Branch, Health Sciences Authority for further advice
in an
ancillary role
4A
Pre-clinical performance evaluation data
All changes to materials that affect performance
Clinical performance evaluation data
Provided?
Type of Change
Documentary Requirements
Yes
specification of a registered IVD medical device,
including changes to biological materials that
involve a change in type, source, processing and/or
supplier of cells, tissues, and/or derivatives of
Information on source of material
animal, human, microbial or recombinant origin
Biological materials (including supplier of materials)
5A
Regulatory approval documents from the
All changes to the labelling of medical devices that
reference agencies for the change
involve addition and/or revision of the approved
indications for use
Device Information
Device labelling for new product(s) with
changes redlined and annotated beside each
amended section
Declaration of conformity document
Pre-clinical studies
Clinical studies
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Risk analysis
Software validation report (For software only)
Changes that involve a reduction of indications for
Reasons
use not due to device safety, quality or efficacy
indications
for
the
reduction
of
approved
considerations
Device labelling for new product(s) with
changes redlined and annotated beside each
amended section
5B
Reasons
All changes to the labelling of medical devices that
contraindications, warnings and precautions
involve
addition,
removal
and/or
revision
for
or
removal
of
of
warnings, precautions and/or contraindications
OR
involves addition of contraindications, warnings
Device labelling with changes redlined and
annotated beside each amended section
Pre-clinical studies
and/or precautions not due to safety, quality or
efficacy issues.
addition
Clinical studies
Risk Analysis
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
5C
Preclinical Studies
Labelling changes that only
- instructs the user to use the device in a different
manner from that originally approved
OR
- involve a change from ‘professional use only’ to
‘home use’
Device labelling with changes redlined and
annotated beside each amended section
Clinical Studies
Software validation report (For software only)
Risk analysis
5D
Labelling changes that involve clarification of
Device labelling with changes redlined and
existing instructions for use, not affecting safety,
annotated beside each amended section
quality or efficacy of the medical device
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
5E
Labelling changes that only
- involve changes in layout, colour, font sizes and
design,
without
change
in
prominence
of
precautions, warning and contraindications
OR
- involve addition and/or removal of languages not
Device labelling with changes redlined and
annotated beside each amended section
required by the Authority
OR
- involve the addition of reference agencies’
approvals (e.g. CE marking)
5F
Device labelling with changes redlined and
Other labelling changes
annotated beside each amended section
Details of changes and
the reason for
changes
Documents
supporting
detailed above
(if applicable)
proposed
changes
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
6A
Justification for addition of product(s) to be
Addition of new medical devices to a device listing
grouped within the registered product based
on GN-12: Guidance on Grouping of Medical
Device for Product Registration
Annex 2 for GN-17 and GN-18: List of
Configurations of Medical Devices to be
Registered
Regulatory approval documents from the
reference agencies
Device Information
Device labelling with changes redlined and
annotated beside each amended section
Declaration of conformity document
Letter of Authorisation (GN-15)
Pre-clinical studies
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Clinical studies
(if applicable)
Risk analysis
Software validation report (For software only)
Manufacturing information
Unless the change
Justification for addition of product(s) to be
involves the addition of new devices of the same
grouped within the registered product based
design, within the existing range of sizes already
on GN-12: Guidance on Grouping of Medical
registered.
Device for Product Registration
OR
involves a design change that does not affect the
safety, quality or efficacy of the medical device
(e.g. changes that improve device ergonomics,
aesthetic modification of the device
Annex 2 for GN-17 and GN-18: List of
Configurations of Medical Devices to be
Registered
Regulatory approval documents from the
reference agencies
Device Information
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Device labelling with changes redlined and
annotated beside each amended section
Declaration of conformity document
Letter of Authorisation (GN-15)
Pre-clinical studies (where applicable)
Software validation report (For software only,
where applicable)
Manufacturing information
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Unless the change
Involves addition of Class A non-sterile medical
Declaration on Registrant’s letterhead to state
(1) The added models are class A non-
device accessories that complement the registered
medical device as a SYSTEM/ GROUP
sterile
(2)
the name of the device affected
(3)
the device identifier
(4)
the name of Product owner for class A
non-sterile device
(5)
name
and
address
for
the
manufacturing site(s) for class A nonsterile device
Letter of acknowledgement from the product
owner of the Class A non-sterile device, that
they have no objection that their said Class
A non-sterile product is to be listed on SMDR
as a part of the registered SYSTEM
/GROUP.
(applicable only where, the
product owner of the Class A non-sterile
device
differs
SYSTEM/GROUP)
from
that
of
the
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
The quality management system certificate
Unless the change
Involves addition of Class A non-sterile medical
device accessories that complement the registered
medical device as a SYSTEM/ GROUP
Declaration on Registrant’s letterhead to state
(1) the added models are class A nonsterile
(2) the name of the device affected
(3) the device identifier
(4) the name of Product owner for class A
non-sterile device
(5) name
and
address
for
the
manufacturing site(s) for class A nonsterile device
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Letter of acknowledgement from the product
owner of the Class A non-sterile device, that
they have no objection that their said Class
A non-sterile product is to be listed on SMDR
as a part of the registered SYSTEM
/GROUP.
(applicable only where, the
product owner of the Class A non-sterile
device
differs
from
that
of
the
SYSTEM/GROUP)
The quality management system certificate
The quality management system certificate
Annex 2 for GN-17 and GN-18: List of
Configurations
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
6B/6C
Justification
All deletions of models from device listing
product(s) to be grouped within the registered
OR
product
Changes which increase or reduce the number of
Propose: Justification for deletion of product(s)
devices in a pack of a registered device
or justification for addition of product(s) to be
OR
grouped with the registered product based on
reduction in the number of models listed due to
GN-12: Guidance on Grouping of Medical
obsolescence and not due to safety, quality or
Device for Product Registration.
for
addition
or
deletion
of
efficacy considerations
Annex 2 for GN-17 and GN-18: List of
Configurations of Configurations
Device labelling for new product(s)
(if applicable)
6D
Declaration of Conformity document
All changes to Product Name only (including
identifier)
Declaration letter from Product Owner on
company letterhead to state that there is no
change to device in all aspects, including
intended use, technical specifications.
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
Annex 2 for GN-17 and GN-18: List of
Configurations of Configurations
Device labelling with changes redlined and
annotated beside each amended section
Letter of Authorisation (GN-15)
6 E (i)
Declaration of Conformity document
All changes to Product Owner
Declaration letter, from Product Owner on
company letterhead, to state that they will
undertake responsibility to provide post market
support and assistance related to the medical
devices <state device name> already supplied
under the former product owner’s name (if
applicable)
Device labelling with changes redlined and
annotated beside each amended section
Letter of Authorisation (GN-15)
If no, please provide justification
Provided?
Type of Change
Documentary Requirements
Yes
6 E (ii)
Device labelling with changes redlined and
A change in Product Owner Address
annotated beside each amended section
Letter of Authorisation (GN-15)
6F
Declaration of Conformity document
A change in regulatory status on rejection or
withdrawal (in any reference agencies) for models
included in the SMDR Listing.
Existing regulatory approval certificate(s)
Documents from relevant regulatory authorities
citing reason for the change in regulatory
status
Reason for
company to withdraw from
regulatory authorities
If no, please provide justification