MOC - Sterile Medical Device Marketing - India

#1
Can anyone shine some light on an 'MOC' for the marketing of sterile medical devices in India? I'm guessing it's an M of C by the way the rest of the request is written. Thanks in anticipation.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
D Management of Change - MOC Procedure and Forms - Engineering, Project, Safety Systems Manufacturing and Related Processes 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M Bioburden Frequency (sterile MD) Other Medical Device Related Standards 2
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
K ISO 15223-1 Sterile barrier system - The 3-layer symbol EU Medical Device Regulations 1
J Sterile medical device expiration date 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
M GSPR 23.3 (h) Manufacturing date on sterile barrier EU Medical Device Regulations 0
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
R Labels on sterile packaging EU Medical Device Regulations 5
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
R Deciding if a medical device shall be supplied sterile or not Other Medical Device and Orthopedic Related Topics 5
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
S Package performance testing for non-sterile Hydrogels US Food and Drug Administration (FDA) 1
D What is your Sterile Medical Device Pouch Peel Strength Spec? Other Medical Device Related Standards 3
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
R Use of the "Non-Sterile" Icon - ISO7000-2609 EU Medical Device Regulations 4
Y Sterile device packaging under MDR EU Medical Device Regulations 3
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
N Medical device non sterile packaging requirement CE Marking (Conformité Européene) / CB Scheme 1
A Sterile Garbage Bag for Clean Room Manufacturing and Related Processes 6
F Bioburden Testing requirements for Non-Sterile Dental Products EU Medical Device Regulations 6
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
V Cleanliness/Bioburden for Non-Sterile Gas Path Medical Devices Other Medical Device Regulations World-Wide 7
Y Shelf Life of Non-Sterile Disposable Drug Inhaler 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
3 Egypt Medical Device Registration: Only required for Sterile Medical Devices? Other Medical Device Regulations World-Wide 10
shimonv Over-Labeling Sterile Packaging - Shelf Life 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Ethylene Oxide Sterile Implantable Medical Device Shelf Life Extension Other Medical Device Related Standards 1
P ISO 10993 - Sterile (Irradiation) Polypropylene Syringe Question Other Medical Device Related Standards 6
K AQL for Sterile Product - Laminate Tubes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F Date of Manufacture and Expiration (Sterile Medical Device) question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
shimonv Packaging Validation for Non-Sterile Package EU Medical Device Regulations 6
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
R Temperature Profile for Transport Simulation (Sterile Eye Drops) Other Medical Device Related Standards 1
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
I Use of the Non-Sterile Symbol (EN980/ISO7000/ISO15223-1) Other Medical Device Related Standards 3
D Class II Sterile Product Shelf Life Labeling - Should we do a recall? Nonconformance and Corrective Action 4
V Are microbial limit tests required for sterile products? Qualification and Validation (including 21 CFR Part 11) 3
T Sterile Medical Device Storage Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom