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PQDx_173 V4 DRAFT 19 December 2019

ABRIDGED PREQUALIFICATION ASSESSMENT

Prequalification of In Vitro Diagnostics

DRAFT FOR COMMENT

comments to be submitted to [email protected] by 29 February 2020

P r e q u a l i f i c a t i o n T e a m - D i a g n o s t i c s

PQDx_173 V4 DRAFT 19 December 2019

© World Health Organization 2019

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PQDx_173 v4 DRAFT 19 December 2019 Page 1

Contents 1

1. Introduction ............................................................................................................................................... 2 2

2. Intended Audience ..................................................................................................................................... 2 3

3. Definitions .................................................................................................................................................. 2 4

4. Abbreviations ............................................................................................................................................. 2 5

5. Rationale for abridged assessment............................................................................................................ 3 6

6. Abridged assessment process .................................................................................................................... 3 7

6.1. Eligibility for abridged assessment ........................................................................................................ 3 8

6.2. Abridged assessment process ............................................................................................................... 5 9

Pre-submission stage ......................................................................................................................................... 5 10

6.2.1. Decision to abridge prequalification assessment .............................................................................. 6 11

6.2.2. Abridged product dossier review ...................................................................................................... 7 12

6.2.3. Manufacturing site(s) inspection of abridged scope ......................................................................... 7 13

6.2.4. Performance evaluation .................................................................................................................... 8 14

6.2.5. Labelling review ................................................................................................................................. 9 15

6.2.6. Prequalification decision ................................................................................................................... 9 16

6.2.7. Cancellation of Application ................................................................................................................ 9 17

7. Relevant documents .................................................................................................................................. 9 18

Annex 1: Abridged product dossier: draft requirements ................................................................................. 10 19

20

21

PQDx_173 V4 DRAFT 19 December 2019 Page 2

1. Introduction 22

World Health Organization (WHO) prequalification of in vitro diagnostics (IVDs) is coordinated 23

through the department of Regulation and Prequalification. Focus is placed on IVDs for priority 24

diseases and their suitability for use in resource-limited settings. 25

26

WHO prequalification of IVDs is a comprehensive quality assessment of individual IVDs through a 27

standardized procedure aimed at determining whether the product meets WHO prequalification 28

requirements. 29

30

The abridged prequalification assessment includes the following components: 31

• review of an abridged product dossier; 32

• performance evaluation, including operational characteristics; 33

• manufacturing site inspection of abridged scope; and 34

• labelling review. 35

36

This document should be read in conjunction with the “Overview of the WHO prequalification of in 37

vitro diagnostics assessment” document PQDx_007, as well as with the other relevant documents 38

set forth in Section 7 below. 39

2. Intended Audience 40

This document has been prepared to provide manufacturers with information on the abridged 41

prequalification assessment. Manufacturers wishing to apply for WHO prequalification of their 42

product(s) should read this document before submitting the pre-submission form for 43

prequalification. 44

3. Definitions 45

Abridged WHO prequalification assessment

Prequalification assessment by WHO including review of an abridged product dossier, performance evaluation, manufacturing site inspection of abridged scope and labelling review

4. Abbreviations 46

BLA Biologics License Application EC European Commission GHTF HSA IFU IMDRF

Global Harmonization Task Force Health Sciences Authority of Singapore Instructions for use International Medical Device Regulators Forum

IVD IVDD IVDR

In vitro diagnostic medical device Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

JMHLW Japanese Ministry of Health, Labour and Welfare PMA Premarket Approval TGA Australian Therapeutic Goods Administration WHO World Health Organization


5. Rationale for abridged assessment 47

The rationale for abridged prequalification assessment is that a prior regulatory approval provides 48

a level of assurance relating to the product’s quality, safety and performance in countries where it 49

is approved, but it cannot always provide the same assurance when the product is used in other 50

jurisdictions, including resource-limited settings. 51

The aim of an abridged prequalification assessment is to avoid duplication of effort and reduce the 52

time taken to prequalify a product by focusing on aspects where WHO prequalification assessment 53

brings added value. WHO will review the pre-submission form and supporting documentation to 54

determine whether the product qualifies for an abridged prequalification assessment. Products 55

that do not qualify for abridged prequalification assessment will undergo a full prequalification 56

assessment 57

WHO will apply the abridged prequalification assessment process, in accordance with this document, 58

in the following instances: 59

1. if a stringently assessed regulatory version is submitted for prequalification; 60

2. if a non-stringently assessed (rest of world) regulatory version of the product is submitted for 61

prequalification assessment but a stringently assessed regulatory version also exists, and there 62

are no substantial differences between the two regulatory versions. 63

WHO reserves the right to shift from an abridged assessment to a full assessment at any stage in 64

the prequalification assessment process, if the manufacturer fails to submit satisfactory evidence 65

supporting a previous stringent review. 66

6. Abridged assessment process 67

6.1. Eligibility for abridged assessment 68

When considering whether a product qualifies for an abridged assessment procedure, WHO takes 69

into account two factors: whether the product has been stringently assessed and, if so, whether 70

the regulatory version of the product submitted for prequalification is the same regulatory 71

version1 that was stringently assessed. The assessments by the following regulatory authorities for 72

the following risk classes are considered to be stringent for purposes of WHO’s abridged 73

prequalification assessment, see Table 1. 74

Table 1- Recognized stringent assessment 75

Regulatory authority Risk classes undergoing stringent assessment

European Union Annex II, List A (IVDD), Class C and Class D (IVDR)

Food and Drug Administration of the United States of America

Class III

Health Canada Class III and Class IV

Therapeutic Goods Administration, Australia Class 3 and Class 4

Ministry of Health, Labour and Welfare, Japan

Class III

Singapore Health Sciences Authority Class C and Class D

1 The “same regulatory version” relates to the information associated with a submission for approval by a regulatory authority. The submitted version is defined by all of the documentation related to development, manufacture and intended use, labelling and post-market surveillance of the product and all the documented evidence supporting the safety and performance claims associated with that submission. If any aspect of this documentation differs in any way between the submissions to different regulatory authorities or assessment bodies (United States Food and Drug Administration, Health Canada, a Notified Body for CE marking, etc.) it is considered to be a different regulatory version.


Based on these factors, a product is eligible for abridged assessment if one of the following 76

conditions is met: 77

• The regulatory version submitted for WHO prequalification has undergone prior recognized 78

stringent assessment by one of the regulatory authorities listed in Table 1 of this document 79

(hereinafter referred to as a “Recognized SRA”); or 80

• The regulatory version submitted for WHO prequalification is different from the version that 81

underwent regulatory review by a Recognized SRA, but there are no substantial differences 82

between the two regulatory versions that will have impact on the safety, quality or 83

performance of the IVD. 84

Conversely, a product is not eligible for abridged assessment if: 85

• The regulatory version submitted for WHO prequalification is different from the version that 86

underwent regulatory review by a Recognized SRA, and there are substantial differences 87

between the two regulatory versions; or 88

• No stringently assessed regulatory version of the product exists. This includes products 89

previously assessed by a Recognized SRA, but not according to an appropriate level of 90

stringency (lower risk classification), and products previously assessed by a regulatory 91

authority other than a Recognized SRA listed in Table1. 92

Products which are determined by WHO to not be eligible for abridged prequalification 93

assessment will be required to undergo a full prequalification assessment. 94

95

Figure 1 summarizes the eligibility requirements and decision process for abridged assessment. 96

97

98

99

100

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

117

118

119

120

121

122

123

Figure 1- Decision tree for abridged assessment

Was the product stringently assessed and approved by a

Recognized SRA

Is the regulatory version submitted for prequalification

the same as that assessed by the Recognized SRA

Are there substantial differences between regulatory versions?

Full prequalification

assessment

NO

YES YES

NO

YES

NO

Abridged prequalification

assessment


Differences between a full and an abridged prequalification assessment 124

125

The full prequalification assessment process includes the following components: 126

• review of a full product dossier; 127

• performance evaluation, including operational characteristics; 128

• inspection of a manufacturing site of full scope; and 129

• labelling review. 130

131

An abridged assessment considers available evidence that an eligible product meets certain WHO 132

prequalification requirements as a result of its stringent regulatory approvals. Table 2 lists the 133

differences between a full and an abridged prequalification assessment. Additional details are 134

provided in Section 6.2 below. 135

136

Table 2 - Differences between a full and an abridged prequalification assessment 137

PQ stage Full assessment Abridged assessment

Review of a product dossier Full product dossier Abridged product dossier

Inspection of a manufacturing site

Inspection of manufacturing site(s) of full scope

Manufacturing site inspection of abridged scope

Performance evaluation, including operational characteristics

Yes Yes

Labelling review Yes Yes

138

6.2. Abridged assessment process 139

Pre-submission stage 140

A prequalification pre-submission form must be submitted by the manufacturer to WHO. Such 141

form will serve to: 142

• provide information on the product submitted for prequalification; 143

• identify the regulatory version submitted for prequalification; and 144

• determine the differences between existing regulatory versions of the product. 145

146

WHO will determine (i) if there is acceptable evidence of prior stringent assessment and approval 147

for the product submitted for prequalification, and (ii) if the product is eligible for abridged 148

assessment. For such evidence to be considered acceptable, the product must meet the 149

requirements for placing on the market in the respective regulatory jurisdiction. Table 3 and 4 150

show acceptable evidence for abridged prequalification assessment. 151

152

Table 3 - Acceptable evidence of stringent regulatory assessment for GHTF/IMDRF Class D IVDs 153

Recognized SRA Acceptable evidence

European Union EC Full Quality Assurance Certificate and EC Design Examination Certificate,

EC Production Quality Assurance Certificate and EC Type-Examination Certificate.


Certificate under Annex IX of the IVDR

Certificates under Annex X and XI of the IVDR


PMA letter or BLA license

Health Canada Medical Device License

Therapeutic Goods Administration, Australia

TGA Full Quality Assurance Certificate and TGA Design Examination Certificate; or

TGA Production Quality Assurance Certificate and Type-Examination Certificate

Japan Ministry of Health, Labour and Welfare

JMHLW Minister’s Approval

Registration to JMHLW of Manufacturer (seizogyo touroku)

Registration to JMHLW of Foreign Manufacturer (gaikoku seizogyosha touroku)

Singapore Health Sciences Authority

Listing on the Singapore Medical Device Register (SMDR) as Class D IVD.

154

Table 4 - Acceptable evidence of stringent regulatory assessment for GHTF/IMDRF Class C IVDs 155

Recognized SRA Acceptable evidence

European Union EC Full Quality Assurance Certificate EC Production Quality Assurance Certificate EC Type-Examination Certificate

Certificate under Annex IX of the IVDR

Certificates under Annex X and XI of the IVDR


PMA letter or BLA license

Health Canada Medical Device Licence

Therapeutic Goods Administration, Australia

TGA Full Quality Assurance Certificate;; or TGA Production Quality Assurance Certificate and Type-

Examination Certificate

Japan Ministry of Health, Labour and Welfare

JMHLW Minister’s Approval

Registration to JMHLW of Manufacturer (seizogyo touroku)

Registration to JMHLW of Foreign Manufacturer (gaikoku seizogyosha touroku)

Singapore Health Sciences Authority

Listing on the Singapore Medical Device Register (SMDR) as Class C IVD2.

6.2.1. Decision to abridge prequalification assessment 156

WHO will determine if the product qualifies for abridged assessment according to Section 6.1 157

above. If the regulatory version submitted for WHO prequalification is different from the version 158

that underwent regulatory review by a Recognized SRA listed in Table 1, WHO will compare the 159

2 Based on the full review by HSA.


key differences between the stringent regulatory version and the regulatory version submitted for 160

prequalification. These differences may include the product description, intended use, test 161

procedure, labelling and instructions for use, quality management system, design, manufacturing 162

site, key suppliers, verification/validation studies, and lot release criteria. 163

As described in Section 6.1 above, if there are substantial differences, the full prequalification 164

assessment will be performed. If there are no substantial differences, the abridged 165

prequalification assessment will be performed. 166

167

NOTE: In some cases, a product may have multiple regulatory versions and associated approvals 168

and more than one of the different types of evidence specified in Tables 3 and 4. Each of these 169

approvals may support different aspects of the WHO requirements, further facilitating the abridged 170

prequalification assessment. Therefore, it is important for the manufacturer to submit to WHO all 171

available evidence of previous stringent regulatory approvals. 172

6.2.2. Abridged product dossier review 173

If the product qualifies for abridged prequalification assessment, the manufacturer must submit 174

the abridged product dossier according to the requirements and provisions set forth in the 175

Product Dossier Checklist3. 176

6.2.3. Manufacturing site(s) inspection of abridged scope 177

Under the abridged prequalification assessment, a manufacturing site inspection of abridged scope 178

will take place. The on-site inspection will be limited to those product- and user-specific processes 179

that are a major focus of WHO prequalification inspections (e.g. risk management, in-use stability 180

under poorly controlled conditions, impact on stability of transportation, information gathered from 181

the market etc., user training and training material additional to the IFU, etc.). 182

In addition to the above-referenced processes, the abridged inspection scope will also take into 183

consideration the findings of the most recent regulatory audit report. There will be limited sampling 184

of some of the general quality management processes and associated records and a follow-up on, 185

or clarification of, individual findings identified in the available report. 186

187

A preliminary report (i.e., close out record) detailing issues of concern (if any) will be provided to 188

the manufacturer usually—but not necessarily— on the final day of the inspection. A final 189

inspection report, including the graded nonconformities will be issued to the manufacturer after 190

the inspection of the manufacturing site(s) as per relevant WHO timelines. 191

192

All nonconformities, regardless of their grading, must be actioned by the manufacturer, as part of 193

a corrective action plan (or CAPA), through suitable corrective actions that identify and address 194

the root cause of each nonconformity. The manufacturer will have the opportunity to submit to 195

WHO up to two corrective action plans. Depending on the nature and number of nonconformities, 196

objective evidence of the effective implementation of proposed corrective actions may be 197

required to be provided by the manufacturer to WHO. WHO will assess the information and 198

evidence provided and decide whether the corrective action plan can be accepted. Conformity 199

with WHO’s prequalification requirements will be established based on, among other things, the 200

Organization’s assessment of such information and evidence. The number and criticality of 201

3 For further information refer to Annex 1: Abridged product dossier requirements


nonconformities may require that the effective implementation of proposed corrective actions be 202

verified by WHO in a follow up inspection, before the nonconformities may be closed off. 203

204

If the product successfully meets WHO’s prequalification requirements, a summary of the findings 205

of the inspection of the manufacturing site(s) will be included in the WHO prequalification public 206

report. In certain cases, WHO may, in its sole discretion, permit the manufacturer to correct 207

specific nonconformities after prequalification, provided that the manufacturer commits in writing 208

to address them by an agreed upon deadline. Such a “commitment to prequalification” will be 209

reflected in the WHO prequalification Final Report Letter and will be verified during any follow-up 210

inspection. Failure by the manufacturer to comply with its commitments to prequalification within 211

the agreed deadlines will result in the removal of the product from WHO’s list of prequalified IVDs. 212

6.2.4. Performance evaluation 213

The purpose of the performance evaluation is to independently verify and evaluate the performance 214

and operational characteristics of the product. It is carried out by specified WHO Collaborating 215

Centre(s) or designated laboratory(ies) (collectively referred to as “evaluating site(s)”), using the 216

WHO prequalification evaluation protocol. The product will be evaluated against pre-determined 217

performance criteria established by WHO. 218

219

The manufacturer must choose one of the following two performance evaluation options, and 220

must indicate its choice in the pre-submission form: 221

• Option 1: Performance evaluation commissioned by WHO and carried out at an evaluating site 222

listed by WHO. The manufacturer must indicate in the pre-submission form its choice to 223

undergo a performance evaluation coordinated by WHO and performed by an evaluating site 224

selected by WHO. 225

• Option 2: Performance evaluation commissioned by the manufacturer and carried out at an 226

evaluating site listed by WHO. The manufacturer must indicate in the pre-submission form its 227

choice to have the performance evaluation performed by an independent laboratory selected 228

by the manufacturer from the list of prequalification evaluating sites.4 If this option is chosen, 229

the manufacturer will be responsible for paying the full cost of the performance evaluation (in 230

addition to paying the applicable prequalification assessment fee) and for coordinating the 231

performance evaluation directly with the evaluating site. 232

Regardless of the option chosen, the performance evaluation must be carried out in accordance 233

with a publicly available WHO protocol developed in collaboration with international experts. 234

WHO will have absolute, exclusive, unfettered control over the manner in which the 235

prequalification assessment process is carried out (including the performance evaluation and/or 236

the publication of results of the prequalification assessment, regardless of the outcome). 237

A summary of the performance evaluation report/findings will be included in the WHO 238

prequalification public report, if the product successfully meets the WHO prequalification 239

requirements. 240

241

Irrespective of whether the product meets WHO prequalification requirements, a summary of the 242

performance evaluation report will be published in a WHO composite report as part of the WHO 243

technical series on the performance and operational characteristics of commercially available 244

IVDs. If the product fails to meet WHO prequalification acceptance criteria for performance 245

evaluations, the application will be cancelled. 246

4 The List of WHO prequalification evaluating laboratories is available at: http://www.who.int/diagnostics_laboratory/evaluations/170308_list_of_pq_laboratories.pdf?ua=1


6.2.5. Labelling review 247

The IFU version for the product which is submitted with the pre-submission form will be 248

considered during the abridged assessment. The manufacturer must obtain WHO’s written 249

agreement prior to implementing any changes to this version of the IFU, otherwise, the 250

application may be cancelled. 251

252

The product labelling will be reviewed as part of the pre-submission form, product dossier, 253

performance evaluation and inspection of manufacturing site(s). The IFU is reviewed for clarity, 254

correctness, consistency with the information submitted in the technical documentation and with 255

international guidance and requirements, and suitability for the target user group in WHO 256

Member States. The overall feedback on the labelling review will be provided to the manufacturer 257

after all abridged assessment components have been completed. If requested by WHO, the 258

manufacturer must amend the labelling before the product can be prequalified. 259

260

The agreed product labelling will be included in the prequalification public report. 261

6.2.6. Prequalification decision 262

WHO will determine whether the product meets the WHO prequalification requirements and can 263

be included in the WHO list of prequalified IVDs. The decision to include the product in the WHO 264

list of prequalified IVDs is made based upon information available to WHO at the time of the 265

prequalification assessment, including information obtained as a result of the outcomes of the 266

product dossier review, manufacturing site(s) inspection, the performance evaluation findings and 267

the labelling review. This decision is subject to change on the basis of new information that may 268

become available to WHO. 269

6.2.7. Cancellation of Application 270

If the manufacturer fails to meet WHO prequalification requirements or fails to provide any 271

information or evidence requested by WHO within the specified time periods, or if any of the 272

other conditions outlined Section 10.3 (Cancellation of Application) of the document “Overview of 273

the WHO prequalification of in vitro diagnostics assessment” document PQDx_007, WHO reserves 274

the right to cancel the manufacturer’s application for prequalification of its product. 275

7. Relevant documents276

This document must be read and understood in conjunction with other relevant documents of the 277

WHO Prequalification of IVDs Programme5 including, without limitation, the following: 278

• Overview of the prequalification of in vitro diagnostics assessment: Document PQDx_007279

• Instructions for Completion of the Pre-submission Form: Document PQDx_017280

• Pre-Submission Form: Document PQDx_015281

• Product Dossier Checklist: Document PQDx_049282

• Instructions for Compilation of a Product Dorissier : Document PQDx_018283

• Information for manufacturers on the manufacturing site(s) inspection (assessment of the284

quality management system) Geneva: World Health Organization PQDx_014.285

5 Documents can be accessed through the WHO website: http://www.who.int/diagnostics_laboratory/evaluations/en/


Annex 1: Abridged product dossier: draft requirements 286

287

285 Abridged product dossier content requirement

286 1. ADMINISTRATIVE

287 1.1 Cover letter

288 1.3 List of terms

289 1.4 Application form

290 1.5 Listing of devices

291 1.6 QMS or other regulatory certificates

292 1.7 Free sale certificate / Certificate of marketing authorisation

293 1.8 User fees

294 1.11 Statements/Certifications/Declarations of conformity

295 2. SUBMISSION CONTEXT

296 2.4 Device description

297 2.4.1 Comprehensive device description and principle of operation

298 2.4.3 Description of device packaging

299 2.5 Indications for use and/or intended use

300 2.5.1 Intended use; Intended purpose; Intended user; Indications for use

301 2.5.2 Intended environment / setting for use

302 2.6 Global market history

303 2.6.1 Global market history

304 2.6.2 Global incident reports and recalls

305 2.6.4 Evaluation / inspection reports

306 2.7 Other submission context information

307 2.7.2 Training and support networks

308 3. NON-CLINICAL EVIDENCE

309 3.2 Risk management

310 3.5 Analytical performance

311 3.5.4.2 Precision of measurement (repeatability and reproducibility) - If applicable, studies to establish repeatability undertaken by non-laboratory personnel are provided

312 3.6 Other studies

313 3.6.4 Usability / Human factors

314 3.6.5 Stability of the IVD

315 3.6.5.1 Claimed shelf life

316 3.6.5.2 In-use stability

310 3.6.5.3 Shipping stability

311 5 LABELLING AND PROMOTIONAL MATERIAL

312 5.2 Product/package labels

313 5.3 Package insert/Instructions for use

314 5.6 Technical / operators manual

315 5.8 Other labelling and promotional materials

P r e q u a l i f i c a t i o n T e a m - D i a g n o s t i c s


6. Information package contents6:

316 Element Required documents

317 Quality Management System

318 Quality manual including staff organogram

319 List of current quality management procedures

320 Standard operating procedures for:

321 o Complaint handling and vigilance

322 o Control of nonconforming goods/processes

323

324 o Change control/change notifications (product and processes)

325 o Risk management

326

327 o Supplier evaluation and control, verification of purchased product

328 o Design and development

329

330

Audit report of the most recent full regulatory inspection/audit and all subsequent surveillance inspections/audits

331 Any valid quality management system certificate(s) (e.g. ISO 13485)

332

333 Name and contact details of the responsible person at the site of manufacture regarding the inspection

334 Product

335 Labelling (instructions for use (IFU), component labels and box labels)

336 Photographs of kit, box including contents, kit components

337 Accessories (including photographs)

338 Copy of current product regulatory approval certificate(s)

339

340 Summary of changes initiated or applied to the product subsequent to the above regulatory approvals

341 Manufacturing

342

343 Full address, including latitude and longitude of the manufacturing facility(s)

344 Site floor plan

345 Manufacturing flowchart including in-process control points

346

347 List of critical raw materials (including details of the supplier of each material)

348

349

350

351

List of outsourced processes with direct product impact (e.g. outsourced manufacturing of components (conjugated antibodies, strips, reagents, outsourced laboratory testing, packaging, printing, etc.) including details of the supplier for each process

6The quality management system-related information referenced under the Information package will be

integrated in the abridged product dossier following the ToC format.