What kind of DMR must a Medical Importer have?

D

DRDDO

#1
Dear All
:cool::rolleyes:
Frankly, it is not my concern, because some medical device importers in Thailand ask me this interesting question.
As all of you know, ISO 13485, requires some document call DMR (device master record), :frust: so, for ISO 13485 certified-medical device-importer (from overseas to sales in Thailand), they must have DMR; the problem is what kind of DMR or document must or shall or should they have? :frust: Advice needed.

DRDDO

:whip:
 
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Michael Malis

Quite Involved in Discussions
#2
Dear All
:cool::rolleyes:
Frankly, it is not my concern, because some medical device importers in Thailand ask me this interesting question.
As all of you know, ISO 13485, requires some document call DMR (device master record), :frust: so, for ISO 13485 certified-medical device-importer (from overseas to sales in Thailand), they must have DMR; the problem is what kind of DMR or document must or shall or should they have? :frust: Advice needed.

DRDDO

:whip:
As someone who is involved with Medical Devices daily, I don't know any reason why your Thailand importer NEED a DMR.
Device Master Record is required only for the Manufacturer of the Medical Device. This is the recipe of how to build the product and is confidential information!
 
M

MIREGMGR

#3
"DMR" is an FDA term. The best-corresponding ISO 13485/MDD concepts would be "technical file" or "design dossier".

I hadn't been aware that Thailand applied or referenced ISO 13485 in regard to medical devices. I'm under the impression that that regulatory summary here is still applicable.

In any case, I don't know of a reason why a distributor would want to maintain a DMR or technical file. Perhaps what they actually want is sufficient technical product information to make an appropriate TFDA Class 1 or 2 license filing.
 
D

DRDDO

#4
"DMR" is an FDA term. The best-corresponding ISO 13485/MDD concepts would be "technical file" or "design dossier".

I hadn't been aware that Thailand applied or referenced ISO 13485 in regard to medical devices. I'm under the impression that that regulatory summary here is still applicable.

In any case, I don't know of a reason why a distributor would want to maintain a DMR or technical file. Perhaps what they actually want is sufficient technical product information to make an appropriate TFDA Class 1 or 2 license filing.
main issue is the medical device - importor is iso 13485 certified company, and as indicated in ISO 13485 clause 4.2.1 ....for each type or model of medical device, organization shall establish and maintain a file .......

they needs some document becuase of ISO 13485 requirement, it may be DMR, Technical file from device makers, if it confidential as both of say, how to solve this problem:frust:
:frust:
DRDDO
 

Michael Malis

Quite Involved in Discussions
#5
main issue is the medical device - importor is iso 13485 certified company, and as indicated in ISO 13485 clause 4.2.1 ....for each type or model of medical device, organization shall establish and maintain a file .......

they needs some document becuase of ISO 13485 requirement, it may be DMR, Technical file from device makers, if it confidential as both of say, how to solve this problem:frust:
:frust:
DRDDO
As I mention before, the 4.2.1 clause apply here to device manufacturer (company that legally responsible for this product, including "maintain a file")

I would recommend to clarify what is really needed for Thailand registration vs. your importer perception. They may need some Technical Information not a copy of TF or DMR...
 
D

DRDDO

#6
As I mention before, the 4.2.1 clause apply here to device manufacturer (company that legally responsible for this product, including "maintain a file")

I would recommend to clarify what is really needed for Thailand registration vs. your importer perception. They may need some Technical Information not a copy of TF or DMR...
I see.
:agree1::applause::thanx:
DRDDO
 
B

Bill Goss

#7
So if a company makes medical device components that are designed by a medical device manufacturing company, the contract component manufacturing company does NOT need a DMR nor DHR .... is that what I am hearing?
 
M

MIREGMGR

#8
A contract manufacturer does not maintain a DMR of its own...at least, not one with legal significance...but will want to have ready access to the Manufacturer/designer/marketer's DMR, since it's regulatorily essential that production be conducted in a manner that is controlled by and consistent with the current DMR.

A contract manufacturer does not maintain a DHF...at least, not one with legal significance.

A contract manufacturer normally does maintain the DHR i.e. file of production batch records, on behalf of and as a contractural obligation to the Manufacturer/designer/marketer.

***

On a related note, you use the term "components" in conjunction with "medical devices". If the thing you make is a low-level component that is not significantly related to critical functionality of a finished medical device, its manufacture may not be subject to medical device regulation at all. The assumption above, because you bothered to ask the overall question, is that whatever you make, its "component" status is sufficiently high-level or critically related to functionality of a medical device that the Manufacturer/designer/marketer regards themselves as subject to regulation regarding your process of making it.
 
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