Markets with No Prior Approvals? Without Country of Origin or other Prior Approval

K

kcovington

#1
#1
Hello all,
I am with a small medical device company focused on emerging markets. We do not yet have US FDA clearance or CE Mark approval. We are working towards building out our full quality system, but do not yet have ISO 13485 certification.

I have seen the list before of no reg countries from Reg Desk. My question is - are there countries where it is possible to submit without country of origin or other prior approval, and without a QMS certificate for a Class IIa device?

We identified Ghana as a market where they do not require home country approval, and perform their own GMP audits. Although it's an atypical path, are there other countries people are aware of that would meet this criteria?
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Marc

Marc

Fully vaccinated are you?
Leader
#2
#2
Re: Markets with No Prior Approvals? Without Country of Origin or other Prior Approva

A quick "Bump". My Thanks in advance to anyone who can help with this unanswered question. And, should you be browsing threads and find this one, and it still has no reply, if you can help we will all appreciate it.
 
J

jon.loo

#3
#3
Re: Markets with No Prior Approvals? Without Country of Origin or other Prior Approva

Is there any region you are looking at? In Singapore and Malaysia, prior regulatory approval is not compulsory, although they approval from GHTF countries does help to qualify your device for a "expedited" approval route with lower requirements
 
S

sweetasheaven

#4
#4
Re: Markets with No Prior Approvals? Without Country of Origin or other Prior Approva

kcovington said:
Hello all,
I am with a small medical device company focused on emerging markets. We do not yet have US FDA clearance or CE Mark approval. We are working towards building out our full quality system, but do not yet have ISO 13485 certification.

I have seen the list before of no reg countries from Reg Desk. My question is - are there countries where it is possible to submit without country of origin or other prior approval, and without a QMS certificate for a Class IIa device?

We identified Ghana as a market where they do not require home country approval, and perform their own GMP audits. Although it's an atypical path, are there other countries people are aware of that would meet this criteria?
Click to expand...
Hi there you can consider going into Thailand at the moment as registration is still quite minimal.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L Selling medical devices from USA in EU markets CE Marking (Conformité Européene) / CB Scheme 1
H Medical Devices Regulatory Intelligence for International Markets ISO 13485:2016 - Medical Device Quality Management Systems 1
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
E Responsibilities opening new markets outside EU Medical Device and FDA Regulations and Standards News 0
M Different websites for different markets - FDA, Health Canada or other requirements Medical Information Technology, Medical Software and Health Informatics 4
L BS EN 60601 or IEC 60601 or GB9706 - Our product is going to various markets ISO 13485:2016 - Medical Device Quality Management Systems 4
F Is anyone attending the VonLanthen Summit on Emerging Markets? Other Medical Device Regulations World-Wide 6
Wes Bucey Emerging industries and markets as a career choice Career and Occupation Discussions 5
R Labeling, translation requirements including software interface: EU & other markets EU Medical Device Regulations 2
V Overview of the Medical Device Approval Process in Major Markets Worldwide Other Medical Device Related Standards 2
AnaMariaVR2 Which Emerging Markets Are the Best Bets for Health Care Investment Returns? Hospitals, Clinics & other Health Care Providers 0
P Quotes re: Quality/Standards in Emerging Markets Professional Certifications and Degrees 4
B Medical Device Vigilance Reporting Multi Markets Other ISO and International Standards and European Regulations 2
B Any experience with cCSAus Mark for US and Canadian markets? Various Other Specifications, Standards, and related Requirements 4
P Gemba - Morning Markets - Lean program called Gemba Morning markets Lean in Manufacturing and Service Industries 8
Marc Markets take another dive - 20 FEB 2009 World News 4
Q Employee Involvement / Prediction Markets Quality Manager and Management Related Issues 1
Tim Folkerts Quality of the Economy - Looking at the markets and making predictions Coffee Break and Water Cooler Discussions 3
Randy E-Marketing - How can "e-markets" help redefine an organization? Coffee Break and Water Cooler Discussions 3
Marc Chery looks to pick off Western car markets World News 3
C Developing a management system to accommodate construction markets Philosophy, Gurus, Innovation and Evolution 10
Marc Quality and the Global Redistribution of Markets Philosophy, Gurus, Innovation and Evolution 0
D How to address the content deviation of 'cannot apply criteria of risk acceptability prior to...' ISO 14971 - Medical Device Risk Management 1
C Determining an as received OOT condition during calibration does not affect measurements taken prior to calibration. General Measurement Device and Calibration Topics 16
A Single-Use accessory disinfected prior to use Other Medical Device Related Standards 6
R Disruptions that happen prior to surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Inventory prior to AS9120 certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 10
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
L Unacceptable risk for basic safety prior to or after mitigation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
S IMS Manual Review and Revision Prior to Audit ISO 14001:2015 Specific Discussions 4
A ISO 9001:2015 registrar Auditor requesting copies of procedure prior to audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Q Top Management Change Prior to Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
H Do you have to perform an full internal prior to IATF 16949 audit? IATF 16949 - Automotive Quality Systems Standard 21
R AS9100 FAI - First Article Inspection to a prior Customers PO AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A Internal Audit - Findings - Recent Internet Audit (Prior to Certification) IEC 27001 - Information Security Management Systems (ISMS) 7
S Soak Time to Acclimate prior to Calibration General Measurement Device and Calibration Topics 1
O Process Mapping prior to Validation and Software to use to Map Process Maps, Process Mapping and Turtle Diagrams 12
JoCam Choose Medical Device Distributors prior to Device Registration? Other Medical Device Regulations World-Wide 6
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q ISO 9001:2008 requirement for Design Organization Approval prior to "Repair" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom