Clinical research - Request from ANVISA

L

Lari1808

Registered
I received a request from ANVISA that says the following: '' Submit specific clinical research for the system object of this registration process in order to assess the clinical behavior of the saline to observe the real result of the device's behavior when implanted; considering that the results of pre-clinical tests will require clinical confirmation in view of the risks inherent to this type of stage in the manufacture of the device "

Could you please guide me to what should be done?
 
G

Ghisana F

Registered
Hi,

Do you have any special manufacturing process that could affect the product's implantation so ANVISA can request a clinical evaluation? What is the deadline for you to meet this requirement?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
R CRO (Contract Research Organization) Requirements for MDD Clinical Investigations EU Medical Device Regulations 5
D FDA Approval for Diagnostic Software Clinical / Research US Food and Drug Administration (FDA) 4
K Quality Assurance Clinical Research Auditor - Masters in Total Quality Management Career and Occupation Discussions 3
J Biocompatibility Regulation for Human Studies - Clinical Research Stage 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Clause 7.5.2 applicability to a CRO (Clinical Research Organisation) Qualification and Validation (including 21 CFR Part 11) 3
D Quality Manual Template for Clinical Research Field Quality Management System (QMS) Manuals 5
G Post market surveillance (PMCF) clinical investigation EU Medical Device Regulations 0
M Q: In what circumstances can a clinical investigator submit an EFS/IDE for the Significant Risk Device? US Medical Device Regulations 1
Ed Panek Use of Investigational Device i n Phase 1 Clinical Trial in EU EU Medical Device Regulations 1
G Post-Market Clinical Follow-Up (PMCF) studies EU Medical Device Regulations 0
T Clinical Study Design for IVD Self-Test (lay user) Products UK Medical Device Regulations 0
J US based company no longer selling in the EU: Clinical Evaluation Report and PMS requirements EU Medical Device Regulations 1
D MDR literature review on device without clinical claims EU Medical Device Regulations 7
A Clinical Evaluation Report Between Class I and Class IIa CE Marking (Conformité Européene) / CB Scheme 2
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
S Clinical investigation outside the EU EU Medical Device Regulations 0
B Clinical evaluation according to equivalence with another device EU Medical Device Regulations 4
N Unused proceses (Clinical Evaluation) ISO 13485:2016 - Medical Device Quality Management Systems 4
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
H MDR clinical evaluation EU Medical Device Regulations 0
I Brazil clinical data/trial requirement Other Medical Device Regulations World-Wide 1
Soog1459 Impact to clinical evaluation of MDCG2022-14 EU Medical Device Regulations 2
R Clinical evaluation for instrument of a navigation system EU Medical Device Regulations 1
I Clinical study suppliers (service providers) -- extent of control ISO 13485:2016 - Medical Device Quality Management Systems 4
A Loss of certification because of outdated information in the Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 8
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6
R Clinical Evaluation - state of the art literature search EU Medical Device Regulations 5
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
A Metadata For Drugs, API's, Regulatory & Clinical Documents and Dossier Service Industry Specific Topics 2
M Conducting a clinical investigation with clinical data from India EU Medical Device Regulations 3
V MDR – Article 65 – Clinical investigations on minors EU Medical Device Regulations 6
L Clinical Evaluation MDR EU Medical Device Regulations 15
B Clinical Investigation in Denmark for MDR EU Medical Device Regulations 2
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
S Exclusion of chapter 7.5 production for clinical investigation ISO 13485:2016 - Medical Device Quality Management Systems 1
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
A Post-market Clinical Follow-up Other Medical Device Related Standards 3
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
L Clinical investigation Medical Device and FDA Regulations and Standards News 0
I Clinical evaluation for legacy device EU Medical Device Regulations 16
M Clinical evaluation report training EU Medical Device Regulations 3
Aymaneh Clinical study CE Marking (Conformité Européene) / CB Scheme 1
K Continue to do clinical evaluation? or transfer to RA? or focus on clinical studies as MA? Career and Occupation Discussions 1
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
B Mexico - Clinical Investigation in children Other Medical Device Regulations World-Wide 4

Similar threads

Top Bottom