GROUPING. In Vitro Diagnostic Medical Devices. Dr Jiang Naxin Health Sciences Authority, Singapore 9 October 2012

Transcription

1 In Vitro Diagnostic Medical Devices GROUPING Dr Jiang Naxin Health Sciences Authority, Singapore 9 October

2 Scope Overview IVD Grouping Rules Case Study Q&A 2

3 1 grouped product registration application DE001 C Single OR Multiple SMDR listings DE001 DE002 DE003 Model 001 Model 002 Model 003 Model 004 DE003 1 dossier Multiple product models 3

4 Overview Why? Save time, effort and $$$ When? Upon planning registration A set of rules that allow similar MDs to be registered together in 1 application Who? Manufacturer/Registrant How? Guidance on grouping of medical devices for product registration 4

5 Overview 3 Basic Rules. One product owner; and One common intended purpose One generic proprietary name*. 5

6 Scope Overview IVD Grouping Rules Case Study Q&A 6

7 Qn: How can my IVDs be grouped together? Medical Device General Medical Device SINGLE FAMILY SYSTEM GROUP In Vitro Diagnostic (IVD) Device SINGLE FAMILY SYSTEM GROUP IVD TEST KIT IVD CLUSTER 7

8 IVD TEST KIT 8

9 IVD TEST KIT Reagents or articles: 1. From the same product owner 2. Used in combination to complete a specific intended purpose 3. Sold under a single IVD TEST KIT name or the labeling for each reagents or article states that the component is intended for use with the IVD TEST KIT 4. Compatible when used as a TEST KIT 5. Does not include the instrumentation, such as an analyser, needed to perform the test 9

10 Can my products be grouped together as an IVD TEST KIT? Are the reagents or articles: 1. From the same product owner? 2. Used in combination to complete a specific intended purpose? 3. Sold under a single TEST KIT name or the labelling for each reagents or article states that the component is intended for use with the IVD TEST KIT? 4. Compatible when used as a TEST KIT? 5. Does not include the instrumentation, such as an analyser, needed to perform the test? YES to all: Qualifies to be grouped as an IVD TEST KIT. 10

11 Example: Company X manufactures Reagent R1 and R2 that are used to detect antibodies to HIV. The user has to use positive controls C1 and C2 with reagents R1 and R2 for diagnosis. Clearly stated in all the product inserts as to be used with reagent R1. HSA Zen identi-hiv reagent R1 HSA Zen identi-hiv reagent R2 HSA Zen identi-hiv positive control C1 HSA Zen identi-hiv positive control C2 HSA Zen identi-hiv tubes 1. Are from the same product owner? Yes 2. Can be used in combination to complete a specific intended purpose? Yes 3. Does labelling state that the component is intended for use with the IVD TEST KIT? Yes 4. Compatible when used as a TEST KIT? Yes 5. Does not include instrumentation to perform the test? Yes YES to all: Qualifies to be grouped as a TEST KIT. 11

12 IVD SYSTEM 12

13 Can my products be grouped together as a IVD system? Typically consist of TEST KITs and instruments, for example, an analyzer designed to be used with that TEST KIT. Examples: Blood Glucose Meter and the Blood Glucose Test Strip Urinalysis Test Strip and the Urinalysis Analyzer Are the constituents: 1) From the same product owner? 2) Intended to be used in combination to complete a common intended purpose? 3) Compatible when used as a SYSTEM? 4) Sold under a single SYSTEM name or the labelling, IFU, brochures or catalogues for each constituent component states that the constituent component is intended for use with the SYSTEM? YES to all: Qualifies to be grouped as a IVD SYSTEM. 13

14 Example: Company X manufactures Reagent R1 and R2 that are used to detect antibodies to HIV. The user has to use positive controls C1 and C2 with reagents R1 and R2 for diagnosis. Company X also manufactures special test tubes that are for use with the reagents above. Clearly stated in all the product inserts as to be used with reagent R1. HSA Zen identi-hiv reagent R1 HSA Zen identi-hiv positive control C1 HSA Zen identi-hiv positive control C2 HSA Zen identi-hiv reagent R2 HSA Zen identi-hiv tubes HSA Zen Hi-tec Analyzer Are the constituents: 1) From the same product owner? 2) Intended to be used in combination to complete a common intended purpose? 3) Compatible when used as a SYSTEM? 4) Sold under a single SYSTEM name or the labelling, IFU, brochures or catalogues for each constituent component states that the constituent component is intended for use with the SYSTEM? YES to all: Qualifies to be grouped as a SYSTEM. 14

15 FAMILY 15

16 Can my products be grouped together as a FAMILY? 1. Are from the same product owner? 2. Has a common intended purpose? 3. Are of the same risk class? 4. Has the same design and manufacturing process? 5. Has variations that are within the scope of the permissible variants (GN-12: Annex 1)? YES to all: Qualifies to be grouped as a FAMILY. 16

17 FAMILY Same product owner? Y Same risk class? Y Common intended purpose? Y Same design and manufacturing process? Y Variations are within the scope of permissible variants? Y Submit as 1 FAMILY application N N N N N Cannot be submitted as a FAMILY 17

18 Example of FAMILY (IVD) HSA Zen HSV test kit for 50 reactions HSA Zen HSV test kit consisting of Reagent R1, R2 and test cassette (for 100 reactions- 100 ml) HSA Zen HSV test kit consisting of Reagent R1, R2 and test cassette (for 200 reactions- 200 ml) Qualify as an IVD TEST KIT? 1. Are from the same product owner? Yes 2. Can be used in combination to complete a specific intended purpose? Yes 3. Does labelling state that the component is intended for use with the IVD TEST KIT? 4. Compatible when used as a TEST KIT? Yes 5. Does not include instrumentation to perform the test? Yes Yes Qualify as a FAMILY? 1. Are from the same product owner? Yes 2. Has a common intended purpose? Yes 3. Are of the same risk class? Yes 4. Has the same design and manufacturing process? Yes 5. Has variations that are within the scope of the permissible variants (Closed list)? Yes: Different volume YES to all: Qualifies to be grouped as a FAMILY (of IVD TEST KITs). 18

19 Example: Company X wishes to register 3 types of early pregnancy tests. Can all 3 products be grouped in 1 application? HSA Zen HCG test Cassette HSA Zen HCG test strip HSA Zen HCG test Mid-stream kit 1. Are from the same product owner? Yes 2. Has a common intended purpose? Yes 3. Are of the same risk class? Yes 4. Has the same design and manufacturing process? Yes 5. Has variations that are within the scope of the permissible variants (Closed list)? Yes: Different assembly formats YES to all: Qualifies to be grouped as a FAMILY. 19

20 SYSTEM vs. FAMILY Step 1: Same product owner? Step 2: Iden fy the grouping type FAMILY or SYSTEM? SYSTEM FAMILY Step 2a: Intended to be used in combina on to complete a specific intended purpose? Step 3a: Compa ble? Step 2b: Same risk class? Step 3b: Common intended use & similar design and manufacturing process? Step 4: Permissible variants? (as listed in Annex 2 of GN- 12) 20

21 IVD CLUSTER 21

22 IVD CLUSTER An IVD CLUSTER comprises of a number of in vitro diagnostic reagents or articles, that are: 1) From the same Product Owner 2) Within Class A or Class B 3) Have a common test methodology (Annex 6, GN-12) and 4) From same IVD cluster category (Annex 6, GN-12) YES to all: Qualifies to be grouped as an IVD CLUSTER. *MDs in a IVD cluster will be listed separately. 22

23 Can my products be grouped together as a IVD cluster? An IVD CLUSTER comprises of a number of in vitro diagnostic reagents or articles, that are: 1) From the same Product Owner?; 2) Within class A or class B?; 3) Have a common test methodology (Annex 6, Gn-12)?; and 4) From same IVD cluster category (Annex 6, Gn-12)? 49 cluster categories.. YES to all: Qualifies to be grouped as a IVD CLUSTER. *MDs in a IVD cluster will be listed separately. 23

24 Example of IVD CLUSTER Wen Zen Alpha-Amylase test kit Wen Identi-Creatinine kit Wen Lipase detect kit Can these be grouped together? Annex 6, GN-12 S/N Methodology CLUSTER Category (closed list) 1 Clinical Chemistry Examples of Analytes (non- exhaus ve list) Enzymes (i) Acid Phosphatase (ii) Alpha- Amylase (iii) Crea ne Kinase (iv) Gamma- Glutamyl Transferase (v) Lactate Dehydrogenase (vi) Lipase 1) From the same Product Owner? Yes: Wen 2) Within class A or class B? Yes: Class B 3) Have a common test methodology? Yes: Clinical chemistry (Annex 6, GN-12) 4) From same IVD cluster category? Yes: Enzymes (Annex 6, GN-12) 2 Substrates (i) Albumin (ii) Bilirubin (iii) Urea/Blood Urea Nitrogen (iv) Cholesterol (v) Crea nine (vi) Glucose 3 Electrolytes Reagents 4 Electrolyte Electrodes YES to all: Qualifies to be grouped as a IVD CLUSTER. (i) (ii) (iii) (iv) (v) (vi) (i) (ii) (iii) (iv) (v) (vi) Ammonia Bicarbonate Calcium Chloride Magnesium Phosphate Inorganic/ Phosphorus Ammonia Electrodes Carbon Dioxide (Bicarbonate) Electrodes Calcium Electrodes Chloride Electrodes Magnesium Electrodes Potassium Electrodes 24

25 GROUP 25

26 Can my products be grouped together as a Group? A medical device GROUP is a collection of two or more medical devices, supplied in a single package. The IVD GROUP has: 1. a single proprietary GROUP name; and 2. a common intended purpose. Each item in the GROUP may differ in the number and combination of products that comprise each GROUP, while maintaining the same proprietary GROUP name and the GROUP s intended purpose. YES to all: Qualifies to be grouped as a GROUP. 26

27 Example: Company X wants to supply a glucose monitoring system consisting of a glucose meter, test strips, lancets and lancing device A and/or lancing device B. Company X wants to be able to customize the system based on hospitals needs: Hospital 1: HSA imonitor glucose monitor: containing glucose meter, test strip, lancets and lancing device A and B. Hospital 2: HSA imonitor glucose monitor: containing glucose meter, test strip, lancets and lancing device A only. Hospital 3: HSA imonitor glucose monitor: containing glucose meter, test strip, lancets and lancing B only. 1) Are they supplied in a single package? 2) Are they supplied under a single proprietary name? 3) Common intended purpose? Yes Yes Yes YES to all: Qualifies to be grouped as a GROUP. Submit 1 product registration application. 27

28 Example: HSA imonitor Glucose Monitoring system [Health SA Ltd] For monitoring blood glucose levels. Class C Medical Device DE Health SA Ltd [Health SA Ltd] 123 HSA Road, USA Medical D Pte Ltd 123 HSA Road, Singapore Perfect Glucose meter P-100F Perfect Glucose test strips P-110F Perfect Big Lancing device A P-120F Perfect large Lancing device B P-130F Company X wants to supply 10 units of the lancing device that was registered as part of HSA imonitor glucose monitoring system. It is to be supplied as Perfect Big Lancing device A. Possible? Are the components registered individually as SINGLE? Yes- Can be supplied. No - Cannot be supplied separately. 28

29 SINGLE 29

30 SINGLE (IVD) Device that does not meet IVD TEST KIT FAMILY SYSTEM IVD SYSTEM GROUP IVD CLUSTER It may be offered in a range of package sizes Varying quan es of the SAME product 30

31 Example: Can my products be grouped together as SINGLE? Company X wishes to register pregnancy tests that are sold in various package sizes? XYZ Pregnancy Test Midstream (1 Test/Pack) XYZ Pregnancy Test Midstream (2 Tests/Pack) XYZ Pregnancy Test Midstream (4 Tests/Pack) 1. One product owner? Yes 2. One common intended purpose? 3. One generic proprietary name? Yes Yes SINGLE product application. 31

32 Scope Overview IVD Grouping Rules Case Study Q&A 32

33 No 1: How can the following be grouped? XYZ analyzer: SINGLE XYZ hepatitis B test cassette and XYZ control solutions: TEST KIT XYZ hepatitis B test cassette for 50 tests, XYZ hepatitis B test cassette for 75 tests and XYZ hepatitis B test cassette for 100 tests: XYZ hepatitis B test cassette, XYZ control solutions and XYZ analyzer : SYSTEM FAMILY 33

34 No.2: Can the following be grouped together? Product Name XYZ Aware Urine Early Pregnancy Strip XYZ Aware Urine Early Pregnancy Casse e XYZ Aware Urine Early Pregnancy Midstream XYZ I- Know Urine Early Pregnancy Casse e Descrip on hcg Test Strip hcg Test Casse e hcg Test Midstream hcg Test Casse e Can all of the above be grouped together? Yes FAMILY 34

35 Summary Grouping: In Vitro Diagnos c (IVD) Device SINGLE FAMILY SYSTEM GROUP IVD TEST KIT IVD CLUSTER To be grouped and listed together: 3 Basic Rules. One product owner; and One common intended purpose; and one generic proprietary name.. And for FAMILY Are of the same risk class Has the same design and manufacturing process Has variations that are within the scope of the permissible variants (GN-12: Annex 1) 35

36 Summary And for TEST KIT Used in combination to complete a specific intended purpose. Sold under a single TEST KIT name or the labelling for each reagents or article states that the component is intended for use with the IVD TEST KIT. Compatible when used as a TEST KIT. Does not include the instrumentation. And for SYSTEM Intended to be used in combination to complete a common intended purpose. Compatible when used as a SYSTEM. Sold under a single SYSTEM name or the labelling, IFU, brochures or catalogues for each constituent component states that the constituent component is intended for use with the SYSTEM. 36

37 Summary And for IVD cluster From class A or class B. Have a common test methodology as per Annex 6 of GN-12. From same IVD cluster category as per Annex 6 of GN-12. And for GROUP Supplied in a single package. Components must be registered individually, if they are to be supplied separately. 37

38 Scope Overview IVD Grouping Rules Case Study Q&A 38

39 Thank You! 39