Below provided tentative CE Certification cost for various classes. You may need to take our final proposal after considering all variants and Intended use by filling our quote request form online.
Cost of CE Marking depends on a number of technical files, Device Class, Intended use, constructional material & technology.
| Activity | Class of Medical Device | ||||||
|---|---|---|---|---|---|---|---|
| I | Is / Im / Ir | IIa / IIa (Active) | IIb / IIb (Active) | III | |||
| Technical documentation preparation and coordination with Notified body till certification | 4250 | 7500 | 9000 / 9500 | 12000 / 13500 | 15000 | ||
Additional Cases where further documentation shall be required depending upon product description |
|||||||
| (f) Animal Origin Or Radiation Emitting | – | – | 1000 | 1500 | 2000 | ||
| (g) Ancillary Medicinal Substances | – | – | – | – | 3000 | ||
| (h) Software driven / Standalone Devices | 1000 | 2000 | 2000 | 2000 | 2000 | ||
| Tentative NB Certification Fees (Euro) | NA | 9000 | 12000 | 18000 | 25000 | ||
| Activity | Class of Medical Device | |||
|---|---|---|---|---|
| A | B | C | D | |
| Technical documentation preparation and coordination with Notified body till certification | 4500 | 8500 | 9750 | 15000 |
Additional Cases where further documentation shall be required depending upon product description |
||||
| (h) Software driven / Standalone Devices | 1000 | 2000 | 2000 | 2000 |
| Tentative NB Certification Fees | NA | 9000 | 15000 | 22000 |
| Activity | Class of Medical Device | ||||
|---|---|---|---|---|---|
| I | Is / Im / Ir | IIa | IIb | III | |
| Literature Search Protocol & Literature Search Report only | 1500 | 3000 | 3500 | 5000 | 7500 |
| Complete Clinical Evaluation Plan & Report | 2000 | 4500 | 6000 | 8000 | 9000 |
| Activity | Class of Medical Device | ||||||
|---|---|---|---|---|---|---|---|
| I | Is / Im / Ir | IIa / IIa (Active) | IIb / IIb (Active) | III | |||
| Technical documentation preparation and coordination with Notified body till certification | 4250 | 5600 | 7500 / 8000 | 9750 / 10250 | 15000 | ||
Additional Cases where further documentation shall be required depending upon product description |
|||||||
| (f) Animal Origin Or Radiation Emitting | – | – | 1000 | 1500 | 2000 | ||
| (g) Ancillary Medicinal Substances | – | – | – | – | 3000 | ||
| (h) Software driven / Standalone Devices | 1000 | 2000 | 2000 | 2000 | 2000 | ||
| Tentative NB Certification Fees (Euro) | NA | 9000 | 12000 | 18000 | 25000 | ||
| Activity | Class of Medical Device | ||||
|---|---|---|---|---|---|
| Complete Risk Management Plan and Report | Class I & Class A | Class Is / Im / Ir & Class B | Class IIa & Class C | Class IIb & Class C | Class III & Class D |
| 850 | 1500 | 2000 | 2500 | 3000 | |
| Activity | Route of Application | ||
|---|---|---|---|
| Abbreviated 510K |
Traditional 510k |
Special 510k |
|
| Guidance (Offsite) | 6000 | 7000 | 8000 |
| 510k Preparation & Review | 8000 | 9000 | 10000 |
| Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier | 1000 | 1000 | 1000 |
| total | 15000 | 17000 | 19000 |
| Activity | Route of Application | ||
|---|---|---|---|
| Abbreviated 510K |
Traditional 510k |
Special 510k |
|
| Guidance (Offsite) | 8000 | 9000 | 10000 |
| 510k Preparation & Review | 8000 | 9000 | 9000 |
| Pre- Submission ( 2 Nos) with US Agent, Stationery & Courier | 1000 | 1000 | 1000 |
| total | 17000 | 19000 | 20000 |
| No of Devices | Fees |
|---|---|
| Up to 5 | 1450 |
| Up to 10 | 1700 |
| Up to 20 | 2000 |
| 20+ | 2500 |
The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to NB or CA for review & approval for CE certification.
Read MoreClinical evaluation enables manufacturers to provide sufficient clinical evidence for demonstration of conformity of the device with the general safety and performance requirements.
Read MoreIn India, medical devices were regulated as drugs under the Drug and Cosmetic Act 1940. This concept has changed now, with publication on the Indian Medical Device rule 2017
Read MoreFor legal commercialization of your product, 510k approval process need to be carried out by choosing the type of 510k and complying to the requirements established by the USFDA
Read MoreNIOSH must certify any respirator or respiratory protective product before it can be used in any workplace: medical, industrial, educational, etc. The regulation that empowers NIOSH to regulate and certify respiratory protective products is 42 CFR Part 84.
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