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Registration of Class B Medical Devices – 1
Guidance for Industry Consultation 2
3
1 BACKGROUND 4
5
Medical devices are classified based on a rule based risk classification system into 6 four risk classes – class A to D with class A being the lowest risk class and this is in 7 line with the recommendations from the Global Harmonization Task Force (GHTF). 8 The actual risk classification of each medical device depends on the claims made by 9 the product owner and on its intended purpose. Class B medical devices are typically 10
of low-moderate risk and includes devices such as hypodermic needles, suction 11 apparatus, pregnancy test kits and ultrasound imaging equipment. 12
13
2 EVALUATION ROUTES 14
15
Currently, there are two evaluation routes for Class B medical devices: 16
(i) Full Evaluation Route 17
(ii) Abridged Evaluation Route 18
19
With the enhancements to the medical device regulatory framework announced on 20
20 April 2012, there will be two more evaluation routes for Class B medical devices:- 21
22
(i) Expedited Class B Registration (EBR) Evaluation Route 23
(ii) Immediate Class B Registration (IBR) Evaluation Route 24
25
The eligibility for the different evaluation routes depends on the numbers of prior 26
approvals obtained from HSA’s reference agencies at the point of submission. The 27
types of approvals that qualify for abridged, EBR and IBR evaluation routes are: 28
Australia Therapeutic Goods Administration (TGA) 29
Health Canada (HC) 30
Japan Ministry of Health, Labour and Welfare (MHLW) 31
o Pre-Market Certification from a Japanese Registered Certification 32
Body; OR 33
o Pre-Market Approval from MHLW 34
US Food and Drug Administration (US FDA) 35
o 510K clearance 36
o PMA 37
European Union Notified Bodies (NB) via EC certificates issued according 38
to 39
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o Directive 93/42/EEC Annex II section 3 or Annex V for Class IIA 40
devices 41
o Directive 98/79/EC Annex IV including sections 4 and 6 for List A 42
IVDs 43
o Directive 98/79/EC Annex IV or Annex V with Annex VII for List B 44
and self-testing IVDs 45
46
2.1 Full Evaluation Route 47
A medical device that has not obtained any prior approval from any HSA’s 48
reference agencies at the point of application will be subject to full evaluation route. 49
50
2.1.1 Submission Requirements 51
Letter of Authorisation 52
Annex 2: List of configurations of medical devices to be registered 53
Common Submission Dossier Template (CSDT) 54
a) Executive Summary 55
b) Essentials Principles Checklist and Declaration of Conformity 56
c) Device Description 57
d) Detailed Information of Design Verification and Validation Documents 58
− Full reports of Preclinical Studies including the detailed sterilization 59
validation if applicable 60
− Clinical Evidence, including publications and full reports of the 61
studies referenced in the clinical evaluation report 62
e) Proposed Device Labeling 63
f) Risk Analysis 64
g) Manufacturer Information 65
− Name and address of the manufacturing site(s) 66
− Proof of Quality Management System – e.g. ISO13485 Certificate, 67
Conformity to US FDA Quality System Regulations or Japan MHLW 68
Ordinance 169 69
− Manufacturing Process – Flow Chart 70
71
For medical device with label claims beyond the inherent performance of the device, 72
additional clinical data may be requested to substantiate the proposed label use. 73
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74
2.1.2 Processing of application 75
76
77
78
Upon submission via MEDICS, an application fee will be charged immediately. The 79
application dossier will be verified for completeness before the application is 80
accepted for evaluation. Any omitted documents will need to be addressed via input 81
requests. 82
Upon acceptance of the dossier for evaluation, the evaluation fees will be triggered. 83
The payment mode (GIRO or progressive payment or others) will depend on the 84
applicant’s selection at the point of submission in MEDICS. 85
Evaluation of the dossier by HSA is based on the data set submitted by the applicant. 86
An input request will be issued to the applicant if clarification or additional information 87
is required. A regulatory decision is made based on the outcome of HSA’s evaluation 88
of the submitted dossier. Only application which satisfy the registration requirement 89
will be listed on the Singapore Medical Device Register (SMDR). 90
The stop-clock starts whenever HSA issues an input request and ends when HSA 91
receives a complete and satisfactory response from the applicant. 92
93
2.2 Abridged Evaluation Route 94
A medical device that has obtained at least one reference agency approval for a 95
labeled use similar to that intended for marketing in Singapore at the time of 96
submission will qualify for the abridged evaluation route. 97
2.2.1 Submission Requirements 98
Letter of Authorisation 99
Annex 2: List of configurations of medical devices to be registered 100
Proof of approval by reference agency (e.g. approval letters, certificates) 101
Common Submission Dossier Template (CSDT) 102
a) Executive Summary 103
Submission of
application
via MEDICS
Evaluation of
application
Regulatory decision and
listing on SMDR for
successful registration
Verification
of application
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b) Essential Principles Checklist and Declaration of Conformity 104
c) Device Description 105
d) Summary of Design Verification and Validation Documents 106
− Summary of Preclinical Studies including the sterilization validation if 107
applicable 108
− Clinical Evidence 109
e) Proposed Device Labeling 110
f) Risk Analysis (if applicable) 111
g) Manufacturer Information 112
− Name and address of the manufacturing site(s) 113
− Proof of Quality Management System – Eg: ISO13485 Certificate, 114
Conformity to US FDA Quality System Regulations or Japan MHLW 115
Ordinance 169 116
117
For medical device with label claims beyond the inherent performance of the device, 118
additional clinical data may be requested to substantiate the proposed label use. 119
120
2.2.2 Processing of application 121
122
123
124
Upon submission via MEDICS, an application fee will be charged immediately. The 125
application dossier will be verified for completeness before the application is 126
accepted for evaluation. Any omitted documents will need to be addressed via input 127
requests. 128
Upon acceptance of the dossier for evaluation, the evaluation fees will be triggered. 129
The payment mode (GIRO orprogressive payment or others) will depend on the 130
applicant’s selection at the point of submission in MEDICS. 131
Evaluation of the dossier by HSA is based on the data set submitted by the applicant. 132
An input request will be issued to the applicant if clarification or additional information 133
is required. A regulatory decision is made based on the outcome of HSA’s evaluation 134
of the submitted dossier. Only application which satisfy the registration requirement 135
will be listed on the SMDR. 136
Submission of
application
via MEDICS
Evaluation of
application
Regulatory decision and
listing on SMDR for
successful registration
Verification
of application
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The stop-clock starts whenever HSA issues an input request and ends when HSA 137
receives a complete and satisfactory response from the applicant. 138
139
140
2.3 Expedited Class B Registration (EBR) Evaluation Route 141
(NEW for industry’s feedback) 142
143 2.3.1 Eligibility Criteria 144 145
The following medical devices are eligible for submission via the EBR evaluation 146
route: 147
148
(A) EBR-1: a medical device that has 149
obtained approval from at least one of HSA’s independent reference agencies for 150
a labeled use similar to that intended for marketing in Singapore; and 151
[HSA’s independent reference regulatory agencies are HC, MHLW, US FDA and 152
TGA/EU NB and the corresponding approvals listed under Section 2 Evaluation 153
Route] 154
been marketed for at least 3 years in the above independent reference agency’ 155
jurisdiction [or in Singapore]1; and 156
no safety issues globally, defined as 157
a) no deaths; 158
b) no serious deterioration in the state of health2 globally, 159
160
arising from the use of the medical device(s) as intended by the Product Owner, in 161
the last three years; and 162
163
c) no open field safety corrective actions (including recalls) at the point of 164
submission 165
OR 166
1 Or the medical device has been used in Singapore for at least 3 years prior to the implementation of requirement for
product registration for Class B medical devices on 1st January 2012
2 Serious deterioration in the state of health, in relation to a person means: (a) a life-threatening illness or injury suffered
by that person; (b) a permanent impairment of a bodily function of that person; (c) any permanent damage to any part of that person’s body; or (d) a condition requiring medical or surgical intervention to prevent any such permanent impairment or damage.
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(B) EBR-2: a medical device that has obtained approval from at least two of HSA’s 167
independent reference agencies for a labeled use similar to that intended for 168
marketing in Singapore. 169
2.3.2 Submission Requirements 170
Letter of Authorisation 171
Annex 2 List of configurations of medical devices to be registered 172
Proof of approval from independent reference agencies – [Note: one independent 173
reference agency for EBR-1 and two independent reference agencies for EBR-2] 174
Proof of marketing history in the same independent reference agency’ 175
jurisdictions e.g. Invoice with date, proof of sale – [Note: for EBR-1 only] 176
Declaration of no safety issue globally (Refer to Annex C for the template for this 177
declaration) – [Note: for EBR-1 only] 178
Common Submission Dossier Template (CSDT) 179
a) Executive Summary 180
b) Essentials Principles Checklist and Declaration of Conformity 181
c) Device Description 182
d) Summary of Design Verification and Validation Documents 183
− Summary of Preclinical Studies including summary of sterilization 184
validation if applicable 185
− Clinical Evidence 186
e) Proposed Device Labeling 187
f) Risk Analysis (if applicable) 188
g) Manufacturer Information 189
- Name and address of the manufacturing site(s) 190
- Proof of Quality Management System – e.g. ISO13485 Certificate, 191
Conformity to US FDA Quality System Regulations or Japan MHLW 192
Ordinance 169 193
194
For medical device with label claims beyond the inherent performance of the device, 195
additional clinical data may be requested to substantiate the proposed label use. 196
197
2.3.3 Processing of application 198
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199
200
201
Upon submission via MEDICS, an application fee will be charged immediately. The 202
application will be verified for eligibility for EBR and once confirmed, the application 203
will be accepted for evaluation. The evaluation fees will be charged at this point. In 204
view of the shortened processing timeline, progressive payment will not be an option 205
available for applications submitted via this route. In the event that the application 206
does not qualify for EBR, the application will be re-routed to the abridged evaluation 207
route and the respective evaluation fee shall apply. 208
Evaluation of the dossier by HSA is based on the data set submitted by the applicant. 209
An input request will be issued to the applicant if clarification or additional information 210
is required. A regulatory decision is made based on the outcome of HSA’s evaluation 211
of the submitted dossier. Only application which satisfy the registration requirement 212
will be listed on the SMDR. 213
The stop-clock starts whenever HSA issues an input request and ends when HSA 214
receives a complete and satisfactory response from the applicant. 215
216
2.4 Immediate Class B Registration (IBR) Evaluation Route 217
(NEW for industry’s feedback) 218
219
2.4.1 Eligibility Criteria 220
221 222
A medical device that fulfils the following criteria will be eligible for IBR: 223 224
approval by at least two of HSA’s independent reference agencies for intended 225
use similar to that submitting for registration in Singapore; and 226
marketed for at least 3 years in both independent reference agencies’ 227
jurisdictions; and 228
no safety issues globally, defined as 229
a) no deaths; 230
b) no serious deterioration in the state of health2 231
232
globally, arising from the use of the medical device(s) as intended by the Product 233
Owner, in the last three years; and 234
235
Submission of
application
via MEDICS
Evaluation of
application
Regulatory decision and
listing on SMDR for
successful registration
Verification
of application
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c) no open field safety corrective actions (including recalls) at the point of 236
submission 237
238
In addition, the medical device should not have any rejection/withdrawal in any 239
reference agency or prior rejection/withdrawal in Singapore. 240
HSA’s independent reference regulatory agencies are HC, MHLW, US FDA and 241
TGA/EU NB and the corresponding approvals listed under Section 2 Evaluation 242
Route. 243
244
2.4.2 Submission Requirements 245
Letter of Authorisation 246
Annex 2 List of configurations of medical devices to be registered 247
Proof of approval from independent reference agencies 248
Proof of marketing history in the same two independent reference agencies’ 249
jurisdictions e.g. Invoice with date, proof of sale 250
Declaration of no safety issue globally (See Annex C for the template for this 251
declaration) 252
Common Submission Dossier Template (CSDT): 253
a) Executive summary 254
b) Device description 255
c) For sterile device only: declaration of conformity to ISO sterilization 256
standards for sterile medical devices. If not in conformity to ISO 257
sterilization standards, a summary of sterilization validation is required. 258
d) Proposed device labeling 259
e) Manufacturer Information 260
- Name and address of the manufacturing site(s) 261
- Proof of Quality Management System – Eg: ISO13485 Certificate, 262
Conformity to US FDA Quality System Regulations or Japan MHLW 263
Ordinance 169 264
For medical device with label claims beyond the inherent performance of the device, 265
additional clinical data may be requested post-registration to substantiate the 266
proposed label use. 267
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2.4.3 Processing of application 268
269
270
Upon successful submission via the MEDICS, the medical device will be listed on the 271
SMDR immediately. The total fees will also be charged immediately upon successful 272
submission for this route. As the device is listed immediately upon successful 273
submission, applicants are reminded to ensure that all the required information is 274
entered correctly and accurately. 275
HSA will verify the documents submitted in MEDICS after successful submission. 276
Based on the intended use of the device by the Product Owner, additional licensing 277
conditions may be imposed post-registration. 278
The IBR evaluation route facilitates immediate market access for the medical devices. 279
Any IBR application which fails to fulfill ALL criteria specified under section 2.4.1 for 280
the IBR evaluation route, not supported by the correct documents or a wrong risk 281
class medical device submitted via the IBR evaluation route will result in cancellation 282
of registration and total registration fee will NOT be refunded. This device will have 283
to be re-submitted via other evaluation routes or submitted as other risk class. In 284
these cases, the corresponding new application and evaluation fees shall apply. 285
286
3 GENERAL NOTES 287
All aspects of the medical device’s quality including packaging, labelling (including 288
instruction of use), and intended purpose/indications for use, intended for supply in 289
Singapore shall be the same as that approved by the reference agencies that have 290
approved the medical device. Registrants are required to attach appropriate 291
explanation if there are differences from those stated in the certificates or the 292
reference agency approved labelling. 293
For further information on the specific content and requirements for the letter of 294
authorization and CSDT, please refer to GN-15, GN-17 and GN-18 guidance 295
documents, respectively. 296
A summary of the evaluation routes and its corresponding documentation 297
requirements is attached in Annex A and B respectively. 298
299
Successful submission
of application via
MEDICS
Completion of
registration and
listing on SMDR
Verification of
documents
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Annex A 300
Summary of Evaluation Routes 301
Evaluation Route
Full Abridged Expedited Class B registration - EBR
(NEW for industry’s feedback)
Immediate Class B registration – IBR
(NEW for industry’s feedback)
Criteria
(at the time of submission)
Not approved by any of HSA medical device’s reference agencies
At least 1
reference
agency’s
approval
EBR – 1
At least 1 reference
independent
agency’s approval
Marketed for ≥ 3
years in the above
independent
reference agency’s
jurisdiction*
No safety issues
globally
OR
EBR-2
At least 2 independent reference agencies approvals
At least 2
independent
reference
agencies’
approvals
Marketed for ≥ 3
years in the
above 2
independent
reference
agencies’
jurisdiction
No safety issues globally
No prior rejection/withdrawal by independent reference agencies and Singapore
Targeted Turn-Around-Time
160 working days#
100 working days#
60 working days# Immediate listing upon
successful submission in MEDICS
Total Fee S$4,000 S$2,300 S$1,400 S$1,400
*Or the medical device has been used in Singapore prior to the implementation of requirement for 302 product registration for Class B medical devices on 1st January 2012 303 #Excluding company’s response time to input request 304 305 306
307 308 309 310
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Annex B 311
Summary of Submission Requirements 312
Documentary Requirements Full Abridged
EBR -1 and 2
(NEW for industry’s feedback)
IBR (NEW for industry’s feedback)
1 Letter of authorization
2 Annex 2 List of Configurations
3 Proof of reference agency’s approval(s)
4 Proof of marketing history in the reference agencies’ jurisdictions e.g. Invoice with date,
Only
required for
EBR-1
5 Declaration of no safety issues globally
6 Executive Summary
7 Essential Principles Checklist and Declaration of conformity
8 Device description
9
Design verification and validation documents including :
o Preclinical studies o Clinical evidence
Detailed reports1
Summary2
Summary2
Sterilisation validation for Sterile device
only3
10 Proposed device Labelling4
11 Risk Analysis
If applicable If applicable
12 Manufacturing site’s name and address
13
− Proof of Quality Management
System – Eg: ISO13485
Certificate, Conformity to US
FDA Quality System
Regulations or Japan MHLW
Ordinance 169
14 Manufacturing Process – Flow
Chart
1 Full study reports containing complete descriptions of the objectives, protocols, methods of data 313 analysis, results and conclusions are to be provided. 314 2 A summary of the studies undertaken is to be provided and should include a brief description of 315 the study objectives, test methods, results and conclusions. 316 3 A declaration of conformity to ISO Sterilization standards is acceptable. If not, a summary report of 317 sterilisation validation is required. 318
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4 Medical device with label claims beyond the inherent performance of the device, additional clinical 319
data may be requested to substantiate the proposed label use. For medical device submitted via 320
IBR route, the additional data may be request post registration. 321 322
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Annex C 323
Safety Declaration Template 324 325
[To be printed on Company Letterhead of Registrant] 326
Medical Device Branch 327 Pre-Marketing Division 328 Health Products Regulation Group 329 Health Sciences Authority 330 331 [Date] 332
333
Dear Sir/Madam, 334
335 Subject: Declaration of no safety concerns 336 337 I, [name of Registrant], the applicant for registration of the medical device(s) stated below, hereby 338 declare that there are: 339 340
No deaths 341 342
No serious deterioration in the state of health1 343 344 globally, arising from the use of the medical device(s) when used as intended by the Product Owner, 345 in the last three years from dd/mm/yyyy]; and 346 347
No open field safety corrective actions (including recalls) 348 349 This declaration shall apply to the following medical device(s): 350 351 [List containing product names of medical devices] 352 353 354 I, the applicant, am aware that a false declaration is an offence under the Health Products Act (Cap. 355 122D) and may result in the cancellation of registration of the above medical devices under Section 356 37(1) of the Act. 357 358 Yours Sincerely, 359 360 [Signature] 361 362 [Full Name and Title of Senior Company Official] 363 364 [Company stamp] 365 366 ------ 367 1 Serious deterioration in the state of health, in relation to a person means: (a) a life-threatening illness or injury suffered 368
by that person; (b) a permanent impairment of a bodily function of that person; (c) any permanent damage to any part of 369 that person’s body; or (d) a condition requiring medical or surgical intervention to prevent any such permanent impairment 370 or damage 371