Briefing for Industry - Apr 2010
M di l D
Medical
Device
i IIndustry
d t Briefing
B i fi
26th April 2010
Medical Device Branch
Health Products Regulation Group
Health Sciences Authority
1
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Scope
1.
2
2.
3.
4.
5.
6.
7.
8.
Implementation Milestones (Phase 3)
Product Registration Updates
Dealer’s Licence Updates
Fees Updates
Transition List
Authorisation Routes
Customs Declaration
Medical Devices Currently under Drugs Regulatory
Control
9. Change Notification
10 Clinical
10.
Cli i l T
Trials
i l U
Updates
d t
11. Secondary Assembly
2
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Reproduction of this document in its entirety for internal use is authorised, provided the source is acknowledged.
Briefing for Industry - Apr 2010
Scope
1. Implementation Milestones (Phase 3)
2.
2
3.
4.
5.
6.
7
7.
8.
9.
10.
11.
Product
P
d t Registration
R i t ti Updates
U d t
Dealer’s Licence Updates
Fees Updates
p
Transition List
Authorisation Routes
C t
Customs
Declaration
D l ti
Medical Devices Currently under Drugs Regulatory Control
Change
g Notification
Clinical Trials Updates
Secondary Assembly
3
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Implementation Milestones of Phase 3
First Part (Phase 3a)
From 1 May 2010
4
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Briefing for Industry - Apr 2010
From 1 MAY 2010
1. Implementation of Full Fees for product registration.
i e Standard fees will be applicable
i.e.
applicable.
2. Implementation of Streamlining of Application
dossier type
i.e. ONLY CSDT format shall be accepted for
product
d
registration.
i
i
V
Voluntary
l
P
Product
d
Registration Scheme (VPRS) format has been
phased out.
3. Implementation
p
of FINAL Transition List ((T List).
)
i.e. No more entries to T List after 30 April 2010.
5
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Implementation Milestones of Phase 3
Second Part ((Phase 3b))
From 1 AUGUST 2010
6
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Briefing for Industry - Apr 2010
From 1 AUGUST 2010
1. DEALERS LICENCES ( BUSINESS ACTIVITY )
Implementation of Mandatory Dealers Licences
ii.e. Companies
C
i will
ill need
dM
Manufacturer,
f t
IImporter
t and/or
d/
Wholesaler Licence to deal in medical devices
(regardless of its Risk Class)
7
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From 1 AUGUST 2010
2. MEDICAL DEVICES
Medical Devices allowed to be supplied in Spore:Spore:
i. Registered Class C & D Medical Devices
ii. Class C & D that are on the T List
iii. ALL Class A & B medical devices (until 31 Jul 2011)
iv. MDs licensed with CRPNS(NEA) (until 31 Jul 2011)
v. Unregistered
U
i t d class
l
C and
d D MD
MDs ((e.g. MD
MDs th
thatt are
NOT on the T List) – can ONLY be continued to be
supplied if they have gone through the Authorisation
Routes.
3 SUPPLEMENTARY APPLICATIONS
3.
Fees payable from 1 August 2010
8
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Briefing for Industry - Apr 2010
Scope
1.
2
2.
3.
4.
5.
6.
7.
8.
Implementation Milestones (Phase 3)
Product Registration Updates
Dealer’s Licences Updates
Fees Updates
Transition List
Authorisation Routes
Customs Declaration
Medical Devices Currently under Drugs Regulatory
Control
9. Change Notification
10 Clinical
10.
Cli i l T
Trials
i l U
Updates
d t
11. Secondary Assembly
9
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IMPLEMENTATION
MILESTONES (PHASE 3)
10
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Briefing for Industry - Apr 2010
Medical Device Definition
•
The medical device definition is g
gazetted in Schedule 1 of the
Health Products Act.
•
The above definition can be accessed through the following
weblink:
http://statutes.agc.gov.sg/non_version/html/homepage.html
•
Based on this definition, companies should seek verification
with the product owner on whether their product is controlled as
a medical device.
device
11
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Implementation Milestones
Phase 1 (1 Nov 2007 onwards)
Duties and Obligations under Part VIII of the
Health Products Act came into effect.
effect
1. Maintain Distribution and Complaint Records
2. Report FSCAs and AEs
3 Prohibition against false and misleading
3.
advertisements
Phase 2 (1 Nov 2008 to 30 April 2010)
1. Dealer’s Licencing and Product
Registration commenced (Incentive fees)
Dates are accurate as of 26 April 2010 and are
subject to revision
12
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Briefing for Industry - Apr 2010
Implementation Milestones
Phase 3A (1 May 2010 to 31 July 2010)
1. Product registration standard fees applicable
(incentive fees no longer apply)
2 CSDT d
2.
dossier
i submission
b i i
ffor P
Product
d tR
Registration
i t ti
(VPRS format phased out)
3. Transition List is finalised and published (last entry 30
p 2010))
Apr
Phase 3B (1 Aug 2010 to 31 July 2011)
1. Only licensed dealers shall manufacture, import or
wholesale medical devices (ALL
(
risk class))
2. Unless authorised by HSA or listed on the Transition
List, all unregistered class C and D medical devices shall
be prohibited from supply
Phase 3C (1 Aug 2011 onwards)
1. Only licensed dealers shall manufacture, import or
wholesale
h l
l medical
di l devices
d i
(ALL risk
i k class)
l
)
2. Unless authorised by HSA or listed on the Transition
List, all unregistered medical devices shall be prohibited
pp y
from supply
Dates are accurate as of 26 April 2010 and are
subject to revision
13
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PRODUCT REGISTRATION
UPDATES
14
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Briefing for Industry - Apr 2010
Risk Classification
•
The risk classification rules are specified
p
in: GN-13: Guidance on risk classification of general
medical devices, and
 GN
GN-14:
14: Guidance on risk classification for in-vitro
in vitro
diagnostic medical devices.
•
Companies should seek verify the risk class of their medical
device with the product owner based on its intended purpose.
15
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From 1 August 2010
Product Registration
• Unless authorised by HSA or listed on the Transition List, all
unregistered class C and D medical devices, except for those
currently licensed under the Radiation Protection Act (Cap.
262), shall be prohibited from supply.
•
From 1 August 2011 all Class B medical devices shall require
registration with HSA before supply
•
From 1 August 2011 all medical devices licensed under
Radiation Protection Act (Cap.262) shall require registration
with HSA before supply
•
Authorisation routes for supply of unregistered class C and D
medical
di l devices
d i
become
b
operational.
ti
l
g Notification
Change
• Supplementary application fees become payable.
16
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Briefing for Industry - Apr 2010
Product Registration by 1 August 2011
The following medical devices:• class A medical devices that have not been listed for
exemption from product registration in GN-22:
Guidance on List of Exempted Medical Devices,
• class B medical devices, and
• medical devices which are also licensed under the
R di ti P
Radiation
Protection
t ti A
Actt (C
(Cap.262)
262) b
before
f
1A
Augustt
2011,
shall have
ha e to be registered with
ith HSA if the
they are to be
supplied beyond 1 August 2011.
The above medical devices can still be supplied before
g
2011 even if not registered
g
with HSA yyet.
1 August
17
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DEALER'S LICENCE
18
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Briefing for Industry - Apr 2010
From 1 August 2010
Dealer’s Licences
• Onlyy licensed dealers shall manufacture, import
p or
wholesale medical devices, regardless of risk class.
EXEMPTION
O
The following shall be exempted from the importer’s and
wholesaler’s licensing
g requirements
q
under the Health Products Act :
1) The import and wholesale of medical devices that are licensable
under the Radiation Protection Act (Cap
(Cap. 262) by the Centre for
Radiation Protection and Nuclear Science (CRPNS) of the National
Environment Agency (NEA). (only for these products )
2) The import & supply of medical devices for Clinical Trials
19
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Dealer’s Licences
•
All dealers of medical devices require dealer’s licence, except:
Import and supply of Medical Device for Clinical Trials / medical
devices that are licensable under the Radiation Protection Act
(Cap. 262) by CRPNS
•
Manufacturer s Licence holder will not require to apply for a
Manufacturer’s
Wholesaler’s Licence for medical devices that it manufactures
•
This does not exempt the manufacturer from all applicable
wholesaler’s licence duties and obligations
•
All licences will have licence conditions
•
Licence type “Distributor”
Distributor and “Export
Export-only
only” is obsolete.
obsolete Please
apply for a Importer’s / Wholesaler’s Licence.
20
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Briefing for Industry - Apr 2010
Requirements of Dealer’s Licence
Manufacturer’s Licence
Importer’s Licence
Wholesaler’s Licence
ISO 13485 ((for finished
medical device
manufacturing)
GDPMDS *
OR
ISO 13485 certificate or
letter from certification
body should state that
scope of storage and
distribution is included
(for local manufacturers)
GDPMDS *
OR
ISO 13485 certificate or
letter from certification
body should state that
scope of storage and
distribution is included
(for local manufacturers)
List of Class A exempted
p
medical devices
manufactured
List of Class A exempted
p
medical devices imported
N.A.
*Exceptions: GDPMDS is not required for
•
Import for Re-Export only
•
Import for Non-Clinical Use only
A declaration will be submitted in place of the certificate. Template is available:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/regulatory_guidances.ht
ml
21
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Dealer’s Licence
•
Anyy licence application
pp
received byy 1 Julyy 2010 - will be
processed before 1 Aug 2010.
–
–
•
Any missing / incorrect documents may affect your dealers’
licence approval for 1 Aug 2010.
2010
Note (*): As stated in Guidance GN-02-R1 Guidance on Licensing
for Manufacturers, Importers and Wholesalers of Medical Devices)
Validity of licences will be 1 calendar year starting from 1 Aug
2010.
22
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Briefing for Industry - Apr 2010
Dealer’s Licence
Licences alreadyy approved
pp
in MEDICS.
Therefore, I have a valid licence from 1
Aug 2010?
Licences are only renewed when we receive
paymentt off fees.
f
Licence conditions will be included.
23
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Renewal of Dealer’s Licence (1st round)
If company has
1. An approved
pp
licence in MEDICS as at 14 March 2010
2. No outstanding product registration fee payment
3. Responded to input request for clarification on certification info
b stipulated
by
ti l t d d
due d
date
t (if applicable)
li bl )
Received invoice and made payment
(N GIRO paymentt d
(Non-GIRO
due d
date:
t 5M
May 10)
Licence is renewed with licence conditions.
New expiry date: 31/07/2011
NOTE: Disregard current expiry date (30 April 2010 or 20 July 2010) displayed in
MEDICS
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24
Briefing for Industry - Apr 2010
Renewal of Dealer’s Licence (1st round)
If company did not respond to input request for
clarification
l ifi ti on certification
tifi ti iinfo
f b
by stipulated
ti l t d d
due d
date
t (if
applicable)
Will not receive invoice for licence renewal
Renewal was unsuccessful
25
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Renewal of Dealer’s Licence (2nd round)
2nd round: For companies with outstanding product registration fee
payment.
payment
Will receive invoice by 11 May 10 if outstanding payment is settled
by stipulated due date
(GIRO deduction: 12 May 10
Non-GIRO payment due date: 25 May 10)
Licence is renewed with licence conditions.
New expiry date: 31/07/2011
Note: If payment for outstanding product registration fee was not made by stipulated
due date, no invoice for licences will be sent as the renewal was not successful.
26
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Briefing for Industry - Apr 2010
Renewal of Dealer’s Licence
• If renewals were not successful,,
1. Please cancel the existing licence
(http://www.hsa.gov.sg/publish/hsaportal/en/serv
ices/medics/cancellation.html)
2. Submit a new application
(http://www.hsa.gov.sg/publish/hsaportal/en/serv
ices/medics/dealer_s_licence_.html)
27
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New Dealer’s Licence Applications
after 1st April 2010
• For applications submitted from 1st to 5th April
2010, the payment advice was not automatically
generated.
• Companies will receive invoice by 28 April 2010
• GIRO:
GIRO Deduction
D d ti on 29 April
A il 2010
• Non-GIRO: Payment by 12 May 2010
• Applications can only be processed upon receipt
of payment.
p y
28
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Briefing for Industry - Apr 2010
New Dealer’s Licence Applications
after 1st April 2010
• For applications submitted from 6th April 2010
onwards
 GIRO payment: Payment is automatically
deducted upon submission
 non-GIRO payment: Please make payment
promptly
29
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Payment Modes for Dealer’s Licence
a) GIRO (expedited route)
b) Non-GIRO:
N GIRO
1. Cheque (pay to “Health Sciences Authority”)
mailed to :
Health Sciences Authority
(Medical Device Branch)
11 Biopolis Way #11-01
Helios Building, Singapore 138667
1. Credit Card and NETS (payment has to be
made
d iin-person att the
th Registry
R i t counter
t
@HSA HQ Outram)
We are unable to accept Cash payments.
30
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Briefing for Industry - Apr 2010
GDPMDS – for companies without
existing products
• Email MDB (hsa_md_info@hsa.gov.sg) with
your company’s details and name of
Certification Body who is unable to assist
you.
you
• MDB will be able to provide further advice.
31
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GPDMDS Inspection Scheme
• There is no extension of the GDPMDS Inspection
Scheme. It will be available till 31 May 2010.
• Companies will be advised of GDPMDS Inspection
Scheme application outcome by 30 June 2010.
• Email Audit Branch for any enquiries:
hsa_certification@hsa.gov.sg
32
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Briefing for Industry - Apr 2010
FEES UPDATE
33
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Fee Updates
•
All fees paid are non-refundable.
•
ONLY GIRO payment is accepted for the authorisation routes
that become operational
p
from 1 Aug
g 2010.
•
From 1 Jan 2011, all regulatory fees shall ONLY be payable by
GIRO.
GIRO
34
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Briefing for Industry - Apr 2010
Product Registration Fees
•
Incentive fees shall end on 01 May 2010.
•
From 01 May 2010, standard abridged evaluation route and full
evaluation route fees for class B, C and D medical devices would
apply.
Risk
Classification
Class B
Class C
Class D
Screening
Fees
$500
$500
$500
Abridged
Evaluation Fees
$1,800
$3,500
$5,700
Risk
Classification
Class B
Class C
Class D
Screening
Fees
$500
$
$500
$500
Full Evaluation
Fees
$3,500
$
,
$5,700
$11,400
Total
$2,300
$4,000
$6,200
Total
$ ,
$4,000
$6,200
$11,900
35
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Listing Retention Fees
•
Annual retention fees for class C and D medical devices would be
payable from 01 August 2011
2011.
•
Annual retention fees for class A and B medical devices would be
payable from 01 August 2012
2012.
Risk Classification
Cl
Class
A
Class B
Class C
Class D
Retention Fees
$25
$35
$60
$120
36
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Briefing for Industry - Apr 2010
Authorisation Route Fees
Authorisation Route
Application Fees
GN-26: Named-Patient Basis
$500
GN-27: PHMC Act Licensed Facility
$500
GN-28: Import for Re-export
$500
GN-29: Non-clinical purpose
$500
GN 30 Import
GN-30:
I
t on Consignment
C
i
t Basis
B i
T be
To
b advised
d i d llater
t
NOTE: The submission of application does not guarantee that the application shall be
approved. In cases where the application is rejected or withdrawn, HSA reserves the right
o ccharge
a ge a
an ad
administrative
s a e fee.
ee
to
37
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Change Notification and
Licence Amendment Fees
Change Notification Fees
Risk Classification
Class A
Total
Administrative
Technical
To be advised later
N.A.
TBA
$600
$600
$1,200
$1,200
$2,300
$2,300
Class B
Class C
To be advised later
Class D
Licence Amendment Type
Application Fees
Manufacturer’s
Manufacturer
s Licence
$150
Importer’s Licence
$150
Wholesaler’s
Wholesaler
s Licence
$150
38
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Briefing for Industry - Apr 2010
Change of Registrant Fees
•
The Change of Registrant fees are as follows and shall be payable
from 1 Aug 2010:
Change of Registrant fee
$800
(includes application fee of $500)
NOTE: For applications that are rejected or withdrawn, the application
fee of $500 would not be refunded.
39
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Dealer’s Licence Fees
•
The dealer’s licence fees are as follows:
Type of Dealer’s Licence
Application Fees
Manufacturer’s Licence
$1,000
Importer’s Licence
$1,000
Wholesaler’s Licence
$1,000
NOTE: For applications that are rejected or withdrawn, an administrative
fee of $150 would apply.
40
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Briefing for Industry - Apr 2010
TRANSITION LIST
41
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Transition List
Questions
• What devices qualify to be on the transition list?
• What happens to devices on the transition list?
• What information is on the transition list?
• Where to find the transition list?
42
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Briefing for Industry - Apr 2010
Transition List
Qn: What devices qualify to be on the transition list?
For Class C and D medical devices
devices, as long as the pre-market
applications or supplementary application is submitted through
MEDICS by 30 April 2010, you can continue to import and supply
until they are registered on SMDR. This would not apply to the
f ll i
following:
– Devices that do not qualify for abridged evaluation
– Devices currently subjected to drug registration
• Lubricant, eye
• Viscoelastic material, ophthalmic
• Dialysate
y
concentrate for hemodialysis
y
((liquid
q
or p
powder))
• Solution, irrigating, non-injectable
• Viscoelastic gels for joint lubrication (only as fillers)
– Implantable devices with only 1 reference agency approval
Medical devices whose applications are submitted after 1 May
2010 do not qualify to be on the transition list
list.
43
All Rights Reserved Health Sciences Authority
Transition List
Qn: What happens to devices on the transition list?
1.
Continues to be on the transition list as the device undergoes
evaluation.
l ti
2.
Once the product is approved, it will be removed from the
transition list and will
ill be listed on the SMDR
SMDR.
3.
If application is withdrawn or rejected, the device will be
removed from the transition list.
list
Devices cannot be imported and supplied.
Existing stock in Singapore’s warehouse can be exported or
destroyed with HSA’s authorisation.
destroyed,
authorisation
44
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Briefing for Industry - Apr 2010
Transition List
Qn: What information is on the transition list?
1.
2.
3.
4.
Transition list number
Job reference number
Name of registrant
Name of device as submitted under the “Device Info” section in
MEDICS.
Note: Model numbers will not be available
Qn: Where to find the transition list?
Published on the HSA website on 1 June 2010.
This listing shall be subject to periodic review
review.
45
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AUTHORISATION ROUTES
FOR IMPORT AND SUPPLY OF
UNREGISTERED MEDICAL
DEVICES FROM
1 AUGUST 2010
46
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Briefing for Industry - Apr 2010
Which medical devices require authorisation? (1)
From 1 Aug 2010, only unregistered class C and D medical devices require prior
authorisation from HSA before import and supply.
From 1 Aug 2010 to 31 July 2011, the following medical devices do NOT require
authorisation from HSA prior to import and supply:
• class A and B medical devices
• medical devices on the Transition List
.
exempted from product registration (See GN
GN-22:
22: Guidance on
• medical devices
List of Exempted Medical Devices),
• medical devices which are also licensed under the Radiation Protection Act
(Cap 262)
(Cap.262),
• medical devices for clinical trials, and
• custom-made medical devices
47
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Which medical devices require authorisation? (2)
From 1 Aug 2011 onwards, the following medical devices shall NOT
require authorisation from HSA prior to import and supply:
• medical devices on the Transition List
• medical devices exempted from product registration (See GN-22:
Guidance on List of Exempted Medical Devices),
Devices)
• medical devices for clinical trials, and
• custom-made
medical devices
.
48
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Briefing for Industry - Apr 2010
Authorisation Route Fees
•
•
•
•
•
All application fees for the authorisation routes shall ONLY be payable
via GIRO.
Authorisation route applications may be submitted from 19 July 2010
onwards. Applications submitted before 19 July 2010 would not be
processed.
ONLY GIRO account companies are eligible to apply for authorisation
routes.
Th application
The
li i forms
f
are currently
l available
il bl ffrom the
h ffollowing
ll i
webpage:
http://www.hsa.gov.sg/publish/hsaportal/en/services.html
p
g
gp
p
(Click on the e-services & forms tab on HSA website)
GIRO form to be submitted to HSA Finance:HSA (Finance)
11 Outram Road (S169078)
49
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Summary of Authorisation Routes
Other Authorization
Routes
Import of Custom-made
Medical Devices
Import
p on
Consignment Basis
(Unregistered)
Import on
Consignment Basis
(Registered)
Import for
Non-Clinical
Non
Clinical Purpose
Importer’s
Licence Required?
Wholesaler’s Licence
Required?
Yes
Yes
Yes
N.A (Supply not
authorised)
Yes
Yes
(Exempted from
GDPMDS)
Yes
Yes
Yes
Yes
Yes
(Exempted from
GDPMDS)
Yes
Yes
(Exempted from
GDPMDS)
TAT
(working days)
14 days
No
Supply on Request by
PHMC Licensed Facilities
Supply on
Named Patient Basis
Import for
Re-Export Only
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Briefing for Industry - Apr 2010
Supply on Named-Patient Basis
Purpose
To seek exemption from product registration for the import and supply of an
unregistered medical device for supply to named-patient
Licence
Onl licensed importer will
Only
ill be allo
allowed
ed to import the unregistered
nregistered medical de
device
ice
Application
Procedure
Refer to GN-26: Application Form for Exemption from Product Registration for
p of an Unregistered
g
Medical Device for Supply
pp y on Named-Patient
the Import
Basis
Application
Submitter
Qualified practitioner (patient confidentiality)
Documentary
Requirements
Refer to GN-26: Guidance on the Requirements for Exemption from Product
Registration for the Import of an Unregistered Medical Device for Supply on
Named-Patient Basis
G
Grouping
i
M lti l devices
Multiple
d i
from
f
1 product
d t owner can be
b submitted
b itt d under
d one
application for 1 named-patient 1 import-consignment
NOTE: Authorisation to import and supply would be subject to conditions of approval. Failure
to adhere to these conditions would invalidate the authorisation.
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Supply to Facilities licensed under PHMC Act
Purpose
To seek exemption from product registration for the import and supply of an
unregistered medical device to a clinical laboratory, medical clinic or private
hospital licensed under the PHMC Act (Cap. 248)
Licence
Only licensed importer will be allowed to import the unregistered medical device
Application
pp
Procedure
Refer to GN-27: Application
pp
Form for Exemption
p
from Product Registration
g
for
the Import of an Unregistered Medical Device for Supply to Clinical Laboratory,
Medical Clinic or Private Hospital licensed under the PHMC Act
Application
Submitter
Licensed importer
Documentary
Requirements
Refer to GN-27: Guidance on the Requirements for Exemption from Product
Registration for the Import of an Unregistered Medical Device for Supply to
y, Medical Clinic or Private Hospital
p
licensed under the PHMC
Clinical Laboratory,
Act.
*Attestation by authorised person (i.e. chief executive/ head of
department) from facility is required.
G
Grouping
i
M lti l d
Multiple
devices
i
can b
be submitted
b itt d under
d one application,
li ti
multiple
lti l importi
t
consignment within validity period.
NOTE: Authorisation to import and supply would be subject to conditions of approval.
approval Failure
to adhere to these conditions would invalidate the authorisation.
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Briefing for Industry - Apr 2010
Import for Re-export
Purpose
To seek exemption from product registration for the import of an unregistered
medical device solely for re-export
Licence
Onl licensed importer will
Only
ill be allo
allowed
ed to import the unregistered
nregistered medical de
device
ice
Application
Procedure
Refer to GN-28: Application Form for Exemption from Product Registration for
p of an Unregistered
g
Medical Device solely
y for Re-export
p
the Import
Application
Submitter
Licensed importer
Documentary
Requirements
Refer to GN-28: Guidance on the Requirements for Exemption from Product
Registration for the Import of an Unregistered Medical Device solely for Reexport
Modes of import
Multiple import consignments
Grouping
Multiple devices can be submitted under one application
NOTE: Authorisation to import and supply would be subject to conditions of approval. Failure
to adhere to these conditions would invalidate the authorisation.
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Supply for Non-Clinical Purpose
Purpose
To seek exemption from product registration for the import of an unregistered
medical device to supply for non-clinical purpose.
e g for display at exhibition
e.g.
exhibition, training purposes
purposes, supply of unregistered in-vitro
diagnostic medical device for research-use only purposes, etc
Licence
Only licensed importer will be allowed to import the unregistered medical
device.
Application
Procedure
Refer to GN-29: Application Form for Exemption from Product Registration for
the Import of an Unregistered Medical Device to Supply for Non-Clinical
Purpose
Application
A
li ti
Submitter
Li
Licensed
d iimporter
t
Documentary
Requirements
Refer to GN-29: Guidance on the Requirements for Exemption from Product
Registration for the Import of an Unregistered Medical Device to Supply for
Non-Clinical Purpose
Grouping
Multiple devices can be submitted under one application for 1 import –
consignment
NOTE: Supply for clinical purpose is NOT permitted unless authorised by HSA. Authorisation
to import and supply would be subject to conditions of approval. Failure to adhere to these
conditions would invalidate the authorisation.
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Reproduction of this document in its entirety for internal use is authorised, provided the source is acknowledged.
Briefing for Industry - Apr 2010
Import on Consignment Basis
((Unregistered
g
devices))
Purpose
To seek authorisation* to import a single consignment of low-utilisation
unregistered medical devices under an entity’s importer’s licence.
supply, which has to be sought via
* Does not include authorisation to supply
GN-26 , GN-27 , GN-28 or GN-29.
Licence
Only licensed importer will be allowed to import the unregistered medical device
Application
Procedure
Refer to GN-30: Application Form for Approval to Import on Consignment Basis
(Consignment Unregistered Route)
Application
Submitter
Licensed importer
Documentary
Requirements
Refer to GN-30: Guidance on the Requirements for Approval to Import on
Consignment Basis
Grouping
Multiple devices can be submitted under one application for 1 import –
consignment (tied to invoice number)
NOTE: Authorisation to import would be subject to conditions of approval. Failure to adhere
to these conditions would invalidate the authorisation.
authorisation
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Import on Consignment Basis
(Registered devices)
Purpose
For dealer not authorised by the Registrant to seek authorisation from HSA for
the import of a registered medical device
Licence
Onl licensed importer will
Only
ill be allo
allowed
ed to import the unregistered
nregistered medical
device.
Once approval is obtained, supply can be performed by licensed wholesaler.
Application
Procedure
Refer to GN
GN-30:
30: Application Form for Approval to Import on Consignment Basis
(Consignment Registered)
Application
Submitter
Licensed importer
Documentary
Requirements
Refer to GN-30: Guidance on the Requirements for Approval to Import on
Consignment Basis
Grouping
1 application per device listing from 1 product owner for 1 importconsignment. (tied to invoice number)
NOTE: Authorisation to import and supply would be subject to conditions of approval. Failure
to adhere to these conditions would invalidate the authorisation.
authorisation
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Reproduction of this document in its entirety for internal use is authorised, provided the source is acknowledged.
Briefing for Industry - Apr 2010
Custom-made medical devices
•
Product registration is not required prior to supply
of custom-made medical devices.
•
No need to apply through authorisation route.
•
However, all dealer’s licence requirements apply.
•
For Customs clearance of imports of custom-made
medical devices, a custom-made
custom made medical device
verification form would be made available on the
HSA website in the near future.
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CUSTOMS DECLARATION
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Briefing for Industry - Apr 2010
Customs Declaration
• The following medical devices imported has to be
pp p
HS Code
declared at customs with the appropriate
and product code:
1. Class C and D medical devices on the SMDR
and transition list
2. Medical devices imported via special access
routes
• HS Codes and product codes are required for Class
A exempted,
t d A and
d B medical
di l d
devices.
i
• Email invites to freight forwarders for a briefing on
Tradenet controls will be sent out in July 2010
2010.
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Expiry date will be
updated later
Importer and supplier
will be updated later
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Briefing for Industry - Apr 2010
MEDICAL DEVICES CURRENTLY UNDER
DRUGS REGULATORY CONTROL
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Medical Devices Currently under
Drugs Regulatory Control
Devices currently subjected to drug registration:
•
Lubricant, eye
•
Viscoelastic material,
material ophthalmic
•
Dialysate concentrate for hemodialysis (liquid or
powder)
•
Solution, irrigating, non-injectable
•
Viscoelastic gels for joint lubrication (only as fillers)
From 1 Aug 2010, irrespective of the risk class (Class A,
g
with HSA
B, C or D)) these products have to be registered
before supply. Companies are to inform MDB of the
product registration submission via email.
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Briefing for Industry - Apr 2010
Medical Devices Currently under
Drugs Regulatory Control
Products currently registered with PBB (HSA)
Time p
period
Now to 31 July 2010
Regulatory
g
y Control
Regulated as drug
1 August 2010 onwards Regulated as medical
device
•
•
•
All medical devices currentlyy regulated
g
as drugs
g will be
ported over on 1 Aug 2010.
No Variation Applications can be submitted via PRISM (with
immediate effect).
effect)
Companies shall submit change notification for these
products only when notified by MDB that the applications are
ready for access in MEDICS
MEDICS.
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Medical Devices Currently under
Drugs Regulatory Control
New Applications
Time Period
How to Submit New Applications?
pp
1 Mayy – 31 Jul 2010
Unable to submit new applications.
pp
Freeze period for new applications in
PRISM to facilitate the port over
exercise.
1 Aug 2010 onwards
Submit as a medical device in
MEDICS
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Briefing for Industry - Apr 2010
Medical Devices Currently under
Drugs Regulatory Control
Product licence fees
• P
Product
d t lilicences th
thatt expire
i b
before
f
1A
Augustt 2010
will be renewed via PRISM i.e. Drug licence fees will
apply.
apply
• Product licences that expire on and after 1 August
2010 will be renewed via MEDICS i.e. MD licence
pp y
fees will apply
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All Rights Reserved Health Sciences Authority
Medical Devices Currently under
Drugs Regulatory Control
31 Jul 10
SCENARIO 1
SCENARIO 2
1 Aug 10
31 Jul 11
31 Jul 2010: Listing renewed in
PRISM for 1 year and drug fee is
payable.
01 Aug 11
31 Jul 12
31Jul 2011: Listing renewed in
MEDICS for 1 year and medical
device retention fee is payable.
1 Aug 2010: Listing renewed in
MEDICS for 1 year and medical
device retention fee is payable.
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Briefing for Industry - Apr 2010
CHANGE NOTIFICATION
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All Rights Reserved Health Sciences Authority
Change Notification
Supplementary application fees for Change Notification shall become payable from 1
August 2010. These fees shall be published on the HSA website in the near future.
Change Notification is divided into 3 types:
•
Administrative
•
Technical (without clinical studies) ,and
•
Technical (with clinical studies)
For administrative changes, the medical device can be supplied upon
acceptance of the supplementary application through MEDICS by HSA.
In the event, the supplementary application for an administrative change is rejected,
product supply shall cease. If necessary, a product recall would be mandated.
For technical changes, the medical devices shall not be supplied until approval is
received from HSA.
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Briefing for Industry - Apr 2010
Change Notification - Administrative
The following include changes that would be deemed administrative:
•
change of name and address of manufacturing facility (no change in
manufacturing
f t i process),
)
•
changes to Quality Management Certification (e.g. ISO 13485 certificate for
registered medical device),
•
reduction in approved indications for use,
•
changes to batch numbering system,
other labelling changes (as specified in GN-21)
GN 21),
•
•
deletion of products within a grouped registration,
•
product name change,
•
product owner (including
(
changes to product owner name)) change,
•
regulatory status on rejection or withdrawal (in any reference agencies), and
p
of regulatory
g
y approval
pp
certificates.
•
update
An updated GN-21: Guidance on Change Notification would be published by 31 May
2010
2010.
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All Rights Reserved Health Sciences Authority
Change Notification TAT
•
From 1 August 2010, Change Notification shall be mandatory for registered
class C and D medical devices.
•
From 1 August 2011, Change Notification shall be mandatory for ALL registered
medical devices.
Type of Change Notification
Turn-Around Time
Administrative
N.A
Technical (without clinical studies) 60 days
Technical (with clinical studies)
90 days
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Briefing for Industry - Apr 2010
Input Requests
• For premarket and supplementary applications
applications, only
the following changes are allowed when company
responds to the 1st input request:
1. Addition of models; or
2. Change of manufacturing site. (If change of
manufacturing site also involves a change of
product owner, changes are not allowed)
• Once the 1st input request response is received by
MDB no further changes would be possible
MDB,
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CLINICAL TRIALS
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Briefing for Industry - Apr 2010
Medical Device for Clinical Trials
All Clinical Trials application will be handled by Clinical
Trial Branch (CTB) of HSA
Submit application to CTB directly
M di l d
Medical
devices
i
ffor Cli
Clinical
i lT
Trials
i l are exempted
t d ffrom
product registration.
The following organizations are exempted from
Importer’ss and Wholesaler
Importer
Wholesaler’s
s licence requirement
requirement, when
importing and supply the medical device
Sponsor
Contract Research Organization
3rd party importer
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All Rights Reserved Health Sciences Authority
Medical Devices for Clinical Trials –
Procedure for CTM application
pp
INTERIM APPROACH –
From 1 Aug 2010 till the implementation of the clinical
trial regulations:
In order to Import and Supply Medical Devices for Clinical Trials -
Obtain IRB
approval for the
Cli i l Trial
Ti l
Clinical
Sponsor to
submit CTM
application (hard
copy) to HSA –
Clinical Trial
Branch (CTB)
CTB to Issue
Clearance for
import and
supply of
M di l D
i
Medical
Devices
in the context of
the Clinical Trial
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Briefing for Industry - Apr 2010
Medical Devices for Clinical Trials
– Key Points
 Medical devices authorized for import and supply by the CTM
application, shall not be supplied for use other than in the Clinical Trial.
 Duties and obligations under Part VIII of the Health Products Act 2007
shall apply.
• Reporting of defects and adverse effects to HSA
• Notification to HSA concerning recalls
• Duty to maintain records of import and supply
 The import authorisation would be valid for the period of the Clinical
Trial.
 The medical devices shall be exported out of Singapore, or destroyed
within 6 months of the completion
p
of the trial.
 To maintain proper records on the import, supply and export.
75
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SECONDARY ASSEMBLY
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Briefing for Industry - Apr 2010
Secondary Assembly
•
Secondary assembler is an entity engaged in the process
of packing the medical device, which is in its labelled
primary package, into its secondary package. The process
may also include labelling of the secondary package before
the medical device is sold or supplied.
•
No breach of the primary packaging.
•
The addition of a label bearing their name and address on the
importer and wholesaler of a medical device shall not be
deemed as secondary
secondar assembl
assembly.
 However, the additional label must not cover any text of the
original label.
•
Email invites for a briefing on regulatory controls that apply to
secondary assemblers will be sent out in May 2010
2010.
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All Rights Reserved Health Sciences Authority
Supply from 1 August 2010 to 31 July 2011
Hence, with the exception of the following:• class A and B medical devices,
• medical
di l devices
d i
exempted
t d from
f
product
d t registration
i t ti (S
(See GNGN
22: Guidance on List of Exempted Medical Devices),
• medical devices which are also licensed under the Radiation
Protection Act (Cap.262),
• medical devices for clinical trials, and
• custom-made
t
d medical
di l d
devices
i
all medical devices shall either have to be:
(i) registered on SMDR,
(ii) placed on the Transition List, OR
(iii) cleared for import and supply through one of the authorisation
routes,
prior to supply
supply.
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Briefing for Industry - Apr 2010
Thank you
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