Medical Device Requirements in Panama

A

apuigvert

Involved In Discussions
Hello, yes Panama requires product registration. If that kind of product wasn't registered before you must submit a pre-registration step.

Hope this helps
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B FDA Requirements for medical device to be used for training purposes only US Food and Drug Administration (FDA) 9
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
Aliken Registration veterinary medical device (laser) requirements Medical Device and FDA Regulations and Standards News 2
M Notification Requirements for Medical Device Raw Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Labeling Requirements for Medical Device Travel Case US Medical Device Regulations 9
B Software as a Medical Device - Language Requirements EU Medical Device Regulations 6
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 23
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K China Medical Device Labeling requirements - Language China Medical Device Regulations 9
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 6
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 2
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
Dobby1979 Requirements for the dimensions / color of medical device labels - Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 3
S Medical Device Initial Importer (DII) Requirements - Delivery Address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 20
C FDA Medical Device Label Requirements - serial numbers Other US Medical Device Regulations 9
D Documentation requirements for the new Medical Device Regulations (2019) CE Marking (Conformité Européene) / CB Scheme 5
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
S Medical Device Changes and How to Assess Their Impacts to Essential Requirements EU Medical Device Regulations 2
T Research Medical Device EU - Requirements and Regulations EU Medical Device Regulations 13
L Battery requirements for medical device (US/Canada/EU) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Sam Lazzara Medical Device File Requirements (ISO 13485 Cl. 4.2.3) ISO 13485:2016 - Medical Device Quality Management Systems 11
M Ground stud requirements on our medical device in IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Requirements for sending Medical Device Samples to Indonesia Other Medical Device Regulations World-Wide 5
C ISO 13485 Medical Device File requirements for IVD ISO 13485:2016 - Medical Device Quality Management Systems 1
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8

Similar threads

Top Bottom