Medical Device Registration Phillippines

3

3l5m4r

Hi there,

Does anyone have an idea how the medical device registration process works in the philippines? As a foreign company without subsidiary, would we need a local authorized representative? If yes, can anyone recommend good consultants?

Also, I have found the attached draft of a regulation pertaining medical device registration, but unfortunately, I didn't find any information on whether the law has actually been passed in the meantime or whether it's still a draft.

What about an estimate for a registration timeline -- can anyone help with that?

Thanks in advance for your support. :)
 

Attachments

  • The New Documentary Requirements for the Registration of Medical Device Products.pdf
    197.7 KB · Views: 163

Marc

Fully vaccinated are you?
Leader
A quick "Bump". My Thanks in advanced to anyone who can help with this one.
 

sreenu927

Quite Involved in Discussions
This regulation has not come into effect yet.

For registration at this moment of time, no classification. Most of the products require registration. See attached for the complete list.
You can register your products through your distributor who must have an LTO (License to Operate).
There is a checklist of documents (see attached) require to submit for registration.
Usually it takes 6-9 months for registration.
Initial registration is valid for one year and subsequent renewal is valid for 5 years.

hope this helps!

Regards,
Sreenu
 

Attachments

  • FMC2014-005 - Updated List of Medical Devices required to be Registered Prior to Sale, Distribut.pdf
    1.5 MB · Views: 194
  • 01ACPRMedicalDevices.doc
    131 KB · Views: 174
3

3l5m4r

Hi Sreenu,

Thanks a lot.

2 more quick questions:

1.) You mention that one can register through a distributor who has an LTO -- however: is it necessary to register via local representative or would it also be possible to register without any representative, who's actually physically present on the Phillipines?

2.) Do products for professional use (i.e. not over the counter products) require information material (labeling, IFU) in Filipino or is English sufficient?

-Regards
 

sreenu927

Quite Involved in Discussions
1. If you have a local presence with LTO, then its fine.
2. For Professional use devices, at this moment, English is sufficient.

Regards,
Sreenu
 
Top Bottom