Medical Device Registration in Philippines

G

Gangavaram

#1
Hi members,

Could anyone please help me to understand if we can club multiple products under one application.

Fro ex: 5 Class A products under one application.

I am also looking for any consultants who can work as Local reps for registration and also who are interested to act as distributors for one of my cleint.

Regards,
Pradeep
 
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sreenu927

Quite Involved in Discussions
#2
Re: MD Registration in Philippines

Hi Pradeep,

Class A medical devices or IVDs and this classification is for which Country?
In Philippines, there is no medical device classification.

Pls be more clear so that covers can answer better.

Regards,
Sreenu
 
G

Gangavaram

#3
Dear Members,

We have a client who wants to market their Nasal saline, ear canal products in Philippines.

So we are currently looking for a consultant/entity who can work as a local rep to hold the MA's. :agree:

Can you please help me in finding one.

Thanks in advance for all your support in this regard.

Regards, Pradeep
 
G

Gangavaram

#4
Re: MD Registration in Philippines

Hi Sreenu,

Coming to your suggestion that there is no classification in Philippines, is there anything called "Certificate of Exemption" as many people (from contacts outside elsmar) are suggesting me to go for this initially. I am not able to get proper justification as to why we need to apply for this process or the next steps after getting this certificate.

Also trying to know the fate of the products if this application gets rejected as i believe this application is for exemption and if it gets rejected do i have any other options so that i can get the products into Philippines market.

Can anyone help me to understand RA landscape in Philippines.

Regards, Pradeep
 

somashekar

Staff member
Super Moderator
#5
Re: MD Registration in Philippines

Hi Sreenu,

Coming to your suggestion that there is no classification in Philippines, is there anything called "Certificate of Exemption" as many people (from contacts outside elsmar) are suggesting me to go for this initially. I am not able to get proper justification as to why we need to apply for this process or the next steps after getting this certificate.

Also trying to know the fate of the products if this application gets rejected as i believe this application is for exemption and if it gets rejected do i have any other options so that i can get the products into Philippines market.

Can anyone help me to understand RA landscape in Philippines.

Regards, Pradeep
Hi, Look at THIS
Very encouraging...
Local importers and distributors of medical equipment are required to obtain a license from the Bureau of Food and Drugs (BFAD), which is under the control of the Department of Health (DOH) to operate. Philippine laws require pharmaceutical firms to label their products with their generic names and doctors are obliged to prescribe medicines by their generic names instead of their brand names.

Visit HERE and understand more ...
 
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