Medical Device Industry Briefing - HSA · Medical Device Industry Briefing - HSA ... marketing

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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




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




• 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?




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)




• 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)




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


(MAC)




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


(MAC)




• 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


(MAC)




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.




Change Notification Routes for Registered


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




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


CN-Route (GN-21)






Proposed Changes to

Medical Device

(Class B)



Change?

Is the change



Does change affect

device listing?

a) Submit a Minor

Administrative

Change

Notification

b) Immediate supply

c) No fees



Route

b) Fees:



a) Submit as CN1

b) Immediate supply

c) Fees: TBD

a) Submit as CN2


supply

c) Fees: TBD

YES

YES

NO YES

NO

NO




CN2-Route

Successful

Submission of

CN application

via MEDICS

Regulatory decision

and update of SMDR

for proposed

changes

Verification

and review of

application





• 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






• Product owner (including Product Owners’ details)

• Product name (including product Identifier)

• Addition of new product to device listing






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





• Sterilisation method


• Product name (including Product Identifier)




ADDENDUM A














Changes to the legal Product Owner’s identity, including the Product Owner’s

name and address

Product owner

(including Product Owners’ details)


• 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














Changes to the product name only, including the product “Identifier”

which uniquely identifies the device

Product Name

(including Product Identifier)


• Letter of authorisation (LOA) from Product Owner

• Device labelling (if applicable)

• Declaration from Product Owner on the change in product name


marketing in the HSA’s Medical Device Reference Agency(s)
















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


• 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




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


marketing in the HSA’s Medical Device Reference Agency(s)
















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)


• 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)






Proposed Changes to

Medical Device

(Class B)



Change?

Is the change



Does change affect

device listing?

a) Submit a Minor

Administrative

Change

Notification

b) Immediate supply

c) No fees



Route

b) Fees:



a) Submit as CN1

b) Immediate supply

c) Fees: TBD

a) Submit as CN2


supply

c) Fees: TBD

YES

YES

NO YES

NO

NO




CN 1 Route

Submission requirement

• Summary Table of Change Notification [Annex 2 for CN, GN-21]

• Updated labels including IFU, if applicable


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)


Successful

Submission of

CN application

via MEDICS

Verification of

documents

Registrant

implements

the changes




• 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




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.





Class A Medical Devices

Proposed Changes to

Medical Device

(Class A)



Change?

Is the change



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




Minor Administrative

Change - MAC

(Existing)

Change Notification 1

Route – CN1

(NEW)


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



(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






that intended for


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




action

Not applicable

Eligibility Criteria for CN routes




Eligibility Criteria for CN routes Minor Administrative

Change - MAC

(Existing)


Route – CN1

(NEW)


Route – CN2

(NEW)

Change Notification

Route

(Existing

as per GN-21)



(Class A-D)

Applicable to Class A&B Applicable for Class B

only



(Class A-D)

Closed list of categorical

changes (Table 1)






that intended for







that intended for


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




action




action

Not applicable

MAC CN1 CN2 CN(GN-21)

Increasing level of stringency







Case Studies




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




2) Addition of an early warning alarm to signal potential cardiac event


No.


No.


N.A

Change qualifies for CN Route- GN-21

(Technical Change)





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)


Yes, 1 application

CN Route (Technical) applies





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)




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





No.


Yes.


No.

Change qualifies for CN1

DE0004 DE0005 DE0006

C-12346


(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)




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


(Across Dossier)




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)


HSA Zen Portable

ECG

-ECG

- Electrodes

HSA Zen Pulse Oximeter

- Oximeter

- Sensors

DE001 DE002

C-12345 C-12346




HSA Zen Portable

ECG

-ECG

- Electrodes

HSA Zen Pulse

Oximeter

- Oximeter

- Sensors DE001 DE002



No.


Yes.


Yes.


MDB Zen Portable

ECG

-ECG

- Electrodes

MDB Zen Pulse

Oximeter

- Oximeter

- Sensors DE001 DE002


Equipments






No.


Yes.


No.



Equipments

Can the following changes be submitted as 1 change notification

application?



No. Not identical change across dossiers.

2 separate submissions required.




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.




MEDICS Submission of Change Notification

Application




Change Notification Application (Lower

Risk Class – Class A)

Direct link:

http://www.hsa.gov.sg/publish/hsaportal/en/services/medics/amendment.html




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.




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




6. Select the applicable types of changes and click Update Form. The Main Form

will appear again




7. Click on Edit Info under section 3 Device Info

Main Page




8. Modify the information accordingly and click Update Form. The Main Form

will appear again







9. Click on Edit Info under section 4 Product Owner Info

Main Page





will appear again




11. Click on Add/Edit Info under section 5 Manufacturing Site(s) Info

Main Page





will appear again




13. Click on Add/Edit Info under section 6 Model(s) Info

Main Page




14. Modify the information accordingly and click Update Form. The Main

Form will appear again




15. Click on Attach/Remove Document(s) under section 9 Supporting

Document(s). A prompt will appear.

20. Click OK

Main Page




16. For each Document Type, click Browse to select the file to be uploaded




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




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.




22. Enter Remarks for MDB if any.

23. Check the declaration checkboxes

24. Click Confirm. The Confirmation page will appear

Main Page




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




Change Notification Application (Higher

Risk Class – Class B)

Direct link:

http://www.hsa.gov.sg/publish/hsaportal/en/services/medics/supplementary_a

pplication.html




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




3. Click on Add/Edit Info under section 2 to select the Types of Changes

Main Page




4. Select the applicable types of changes and click Update Form. The Main

Form will appear again




MAC




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)




Main Page

5. Click on Edit Info under section 3 Affected Device Listing




6. Select the affected devices and click Add




7. Click Update Form. The Main Form will appear again




Main Page

8. Click on Attach/Remove Document(s) under section 4 Supporting Document(s).




9. Select the Device Listing you wish to upload document




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.




13. Enter Remarks for MDB if any.

Main Page




14. Click Confirm. A prompt will pop up to remind the applicant to submit all

changes collectively.

15. Click OK.




The Confirmation page will appear. The Submit button is only enabled when the

Declarations are accepted




16. Click Submit. Payment Advice page will appear.

17. Proceed to make payment according to submit the application




Documents

Medical Device Industry Briefing - HSA · Medical Device Industry Briefing - HSA ... marketing