Medical Device Registration Phillippines

3

3l5m4r

#1
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

Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
A quick "Bump". My Thanks in advanced to anyone who can help with this one.
 

sreenu927

Quite Involved in Discussions
#3
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

3

3l5m4r

#4
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
 
Thread starter Similar threads Forum Replies Date
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
MDD_QNA Medical Device registration Argentina Other Medical Device Regulations World-Wide 0
R Medical device registration in Iran Other Medical Device Regulations World-Wide 0
G Device Registration Ammendments - Modifications to Medical Devices Other Medical Device Regulations World-Wide 4
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 3
A Philippines Medical Device Registration Transfer Other Medical Device Regulations World-Wide 1
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
S Uzbekistan - Medical Device Registration Other Medical Device Regulations World-Wide 1
L Medical device registration in African/Asian countries Other Medical Device Regulations World-Wide 11
S FEE Registration LINK - EU Medical Device CE Marking (Conformité Européene) / CB Scheme 6
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
F IVD/Medical Device Registration (with MHRA DORS account in the UK) EU Medical Device Regulations 3
A Russia- Medical device with drug registration Other Medical Device Regulations World-Wide 0
3 Egypt Medical Device Registration: Only required for Sterile Medical Devices? Other Medical Device Regulations World-Wide 10
S Australian Registration of Non-CE Marked Medical Device CE Marking (Conformité Européene) / CB Scheme 2
Q Medical Device Establishment Registration/Listing for Foreign Private Labeler Other US Medical Device Regulations 8
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 9
B Strategy for Registration a Medical Device in China China Medical Device Regulations 2
Q RFID (radio frequency identification) registration for Medical Device Other Medical Device Regulations World-Wide 6
G Design Philosophy - Iran Medical Device Registration Other Medical Device Regulations World-Wide 7
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
G Medical Device Registration in Pakistan Other Medical Device Regulations World-Wide 3
Fatima444-4 Local Medical Device distributor registration UAE Other Medical Device Regulations World-Wide 1
K Medical device registration in Brunei Other Medical Device Regulations World-Wide 1
N Malaysian Medical Device Registration Requirements Other Medical Device Regulations World-Wide 8
I FDA Medical Device Registration - Scenario - Two Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Medical Device Registration and Listing Help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
B Taiwan Medical Device registration - Production or legal office Other Medical Device Regulations World-Wide 6
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
J Medical Device Registration in Venezuela Other Medical Device and Orthopedic Related Topics 4
JoCam Choose Medical Device Distributors prior to Device Registration? Other Medical Device Regulations World-Wide 6
E Medical Device Registration requirements for Bahrain Other Medical Device Regulations World-Wide 4
B Israel Medical Device registration Other Medical Device Regulations World-Wide 3
S Medical Device Registration in Republic of Moldova Other Medical Device Regulations World-Wide 0
R Medical Device and Accessory Establishment Registration and Listing Query Other US Medical Device Regulations 7
Q Mexico Medical Device Registration - Private Hospital Exemption Other Medical Device Regulations World-Wide 1
pittmatj Mexico - COFEPRIS Medical Device Registration Information Other Medical Device Regulations World-Wide 4
D Australian Registration of a CE Marked Medical Device Other Medical Device Regulations World-Wide 2
F Medical Device Registration in Slovenia EU Medical Device Regulations 1
M Austria Medical Device EU Distributor Registration EU Medical Device Regulations 2
X Indian Medical Device Registration Requirements Other Medical Device Regulations World-Wide 6
M Information about the registration of a Medical Device in Thailand Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom