Central/South America Regulatory Approval

A

aoldendo

#1
Hi all:

Is there a repository somewhere on the cove detailing regulatory approval process for US manufacturers to be able to sell their devices into most of Central/South America (sans Mexico and Brazil)? Might this information be somewhere else on the web?

Thanks...
 
Elsmar Forum Sponsor
Y

yana prus

#3
Hi aoldendo:

I would suggest you to reffer to the excellent article that was published in Regulatory Focus by RAPS in february 2010 - you can find there the comprehensive and updated info for registration process of medical device in Latin America (Argentina, Colombia, Costa Rica, Uruguay and Venezuela).

http: //www .raps. org/personifyebusiness/Portals/0/Documents/focus_feb10_md_latin-america.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Regards,

Yana
 

Attachments

Last edited by a moderator:
A

aoldendo

#4
arios,

Thank you for pointing out the thread on Venezuela. It provides us with information on a country we would like to sell into.

Yana,

The paper you referenced is indeed an excellent and vital source of information for us. I used it for the report I wrote to members of our management team. Thanks!

What do you think would be a useful strategy for approaching the countries without a regulatory approval process in place? Simply get in touch with the appropriate health ministry or equivalent?

Sincerely,
A
 
Y

yana prus

#5
Hi,

What do you think would be a useful strategy for approaching the countries without a regulatory approval process in place?
It's an interesting question as to responsibility of regulatory department.

The simplest approach is to cooperate with the distributors as to providing them with the necessary documents/info. It is worth to add to the contract with the distributors that they are ultimately responsible for the registration of the product in their Territory (and will bear the fees).

Regards,

Yana
 
M

MIREGMGR

#7
The simplest approach is to cooperate with the distributors as to providing them with the necessary documents/info. It is worth to add to the contract with the distributors that they are ultimately responsible for the registration of the product in their Territory (and will bear the fees).
Acknowledging that this is the most common global approach to device regulation in countries for which most devices are imported, we still have a problem with it.

Our experience and observation is that distributors who are made responsible for regulatory matters on a manufacturer's behalf, have conflicted motivations in regard to providing full feedback to the manufacturer regarding regulatory interactions and reported events.

And, distributors have undue power in such a relationship, because they "own" at least a significant part of the manufacturer's access to their national market. Depending on the distributor's relationship with the local regulatory authority and (in the real world) the extent to which the local system is dependent who-knows-who and on informal motivational payments, that "ownership" may be complete, with any effort by the manufacturer to change or correct a well-connected distributor doomed to failure.

We vastly prefer selling into countries where distributors have no responsibility or role in the regulatory system, and the regulatory authority interacts directly with us as the manufacturer. We never want a distributor to be responsible for our regulatory status in their country.
 
A

aoldendo

#8
MIREGMGR,

Thank you for your insightful comments. We will keep this in mind as we move forward into foreign markets.

- A
 
M

Marco L.

#9
Dear all,

I would like to have information about user's manual of medical devices. Is there the possibility to provide electronic IFU in the following countries: Argentina, Bolivia, Cuba, Colombia, Chile? Does exist a guide or a legal document to which I can refer?

Thank you very much!
 
Thread starter Similar threads Forum Replies Date
C X-Ray Producing Product Regulations in Mexico, Central America, and South America Other Medical Device Regulations World-Wide 2
N More Central Limit Theorem Questions Six Sigma 4
K Half-Fractional vs. Full Factorial Central Composite Design Using Minitab Software 6
I Shewhart Constants vs Central Limit Theorem in calculating Control Limits Statistical Analysis Tools, Techniques and SPC 18
AnaMariaVR2 Temperature Controlled Biopharmaceutical Logistics in Central America [infographic] Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
T Locating Medical Device Regulations in Central America Other Medical Device Regulations World-Wide 4
bobdoering SPC for Precision Machining Presentation March 25, 2010 ASQ Central Kentucky Section ASQ - American Society for Quality 1
xcanals_tecno-med.es ISO 13485 in Hospital Central Sterilization and Clinical Engineering Services ISO 13485:2016 - Medical Device Quality Management Systems 27
S Distributions - You can't approximate everything with central limit theorem? Six Sigma 12
Marc Time Warner Cable may Lose Viacom: MTV, Nickelodeon, Comedy Central MAY Go Dark After Work and Weekend Discussion Topics 3
E Using Median for Central Location - Analysis of Nonparametric Data Quality Tools, Improvement and Analysis 7
Marc Central European Automotive Manufacturers and TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
D T tests - To test for central measure (means) - Steel supplier Statistical Analysis Tools, Techniques and SPC 8
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
E Recommendations for CBs south of England AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
E South Korea, MFDS - GMP inspections Other Medical Device Regulations World-Wide 4
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
BradM Hurricane Harvey - Texas - August 2017 - Any South Texas Friends out there? Coffee Break and Water Cooler Discussions 10
K Medical Device Regulations in South Africa - Company makes thousands of Products Other Medical Device Regulations World-Wide 1
K New South African Medical Device License Requirement? (Jan 2017) Other Medical Device Regulations World-Wide 6
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
L South of England - experienced Auditor / QMS looking for a new job Career and Occupation Discussions 1
S Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact? Other Medical Device Regulations World-Wide 4
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
E Medical Device Distribution Quality Management in South Korea Other Medical Device Regulations World-Wide 0
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
B Combination Product South Africa CTD Other Medical Device Regulations World-Wide 1
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
S South Korea Ultrasound Software Requirements Other Medical Device Regulations World-Wide 1
M South Africa New Draft Regulations - Regulation Gazette No 37579, 22 April 2014 Other Medical Device Regulations World-Wide 2
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
Hershal Change in the South as I knew it back then Coffee Break and Water Cooler Discussions 3
V LEED Certification - South America Market Sustainability, Green Initiatives and Ecology 2
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
C Registration of Electromedical Device in South Africa Other Medical Device Regulations World-Wide 9
J Disinfectant Registration in Republic of Korea (South Korea) Other Medical Device Regulations World-Wide 2
C South Korean KFDA's KGMP Audit- Anyone with Firsthand Experience to share? Other Medical Device Regulations World-Wide 4
K South Korea IVD Medical Device Classifications Other Medical Device Regulations World-Wide 13
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
S Veterinary Diagnostic Kits Regulations in South East Asia Other Medical Device Regulations World-Wide 8
G Transfer of Import Licenses - Medical Device Regulations in South Africa Other Medical Device Regulations World-Wide 5
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
J Medical Software Regulatory Requirements for South America and Middle East Other Medical Device Regulations World-Wide 3
B Regulatory Requirements for for Class IIa Electro Medical Devices for South America Other Medical Device Regulations World-Wide 4
Hershal Tornadoes in the South of the US - April 2011 Coffee Break and Water Cooler Discussions 18

Similar threads

Top Bottom