Good Distribution Practices (GDP) and similiar for Medical Devices

pseudoazurin

Involved In Discussions
#1
Good Day Everyone,

I know that there is Good Distribution Practice for Medical Device in Singapore, Eucomed and Ireland (MHRA as well??) and coming up in Malaysia. WHO's GDP guidance "...Although medical devices are not included in the definition of pharmaceutical products for the purposes of this document, the main principles established in this document may also be used where applicable for medical devices...", is there any other country/agencies that already have or is going to have GDP or other medical device distribution control approach/gudiance/standard, voluntary or obligate or not.

Would Good Sales/Storage Practice be consider part of distribution control as well? Has anyone taking that seriously?

Many Thanks!
 
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Marcelo

Inactive Registered Visitor
#2
In some regulatory systems, the main distributor (generally the registration holder or the like) is treated as the manufacturer and so does have to comply with requirements for manufacturers...in Brazil, for example, they have to comply with relevante clauses of the Brazilian GMP (although there´s an ongoing debate wheter or not it´s really required by the law, for the company to be granted a licence to function the GMP requirements are audited).
 

pseudoazurin

Involved In Discussions
#3
Thx. Marcelo,

Is there anywhere I can get hold of a copy of Brazil's GMP in English, and can Brazil's distributors certified for "GMP"? I presume that they will be allowed to be exempted for many of the clauses of GMP, like design control and even certain document control (e.g. DMR. Technical file like requirment).

BTW, has anyone got experience with Korea FDA's Good Importing Practice, is it GDP like requirment or is it something else?

Many thanks.
 

Marcelo

Inactive Registered Visitor
#4
Hello

Anvisa does not provide english versiond of their medical devices regulations.

But you are correct, distributors are exempted from many of the requirements of RDC 59.
 
P

patel1234

#5
In some regulatory systems, the main distributor (generally the registration holder or the like) is treated as the manufacturer and so does have to comply with requirements for manufacturers...in Brazil, for example, they have to comply with relevante clauses of the Brazilian GMP (although there´s an ongoing debate wheter or not it´s really required by the law, for the company to be granted a licence to function the GMP requirements are audited).
Can you Help that QC Log Books and Lot No. Log Books are controlled document? I m Working in Medical Devices Manufacturing Company NJ USA

Regards,
Uday
 
Y

ymunwai

#6
Hi, Please see attached quideline for GDP which I obtained from the web.
I know TUV SUD MALAYSIA can do GDPMDS Certificaitons and I also heard that their are very professional.
 

harry

Super Moderator
#7
...................... I know TUV SUD MALAYSIA can do GDPMDS Certificaitons and I also heard that their are very professional.
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Last edited:
Y

ymunwai

#8
Noted on this. Appologize for not reading the TOS. I shall follow the terms in the future. I will take down the MSG.
 
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