Papua New Guinea Medical Device Regulations

[chloep17]

Hi there,

We are a UK based Class IIa, IIb and III medical device manufacturer. We have had some interest in our product in Papau New Guinea but have no experience of the regulatory requirements for the country. Has anyone had any experience that they can share on the regulatory hurdles?

Many thanks

 

[AnaMariaVR2]

Re: Papau New Guinea Medical Device Regulations

http://www.wipo.int/wipolex/en/text.jsp?file_id=199156

PAPUA NEW GUINEA - Department of Health
http://www.health.gov.pg/

http://www.who.int/medical_devices/countries/png.pdf

sorry...I'm in a rush but here are some resources to hopefully start from...

New Zealand High Commission Port Moresby, Papua New Guinea
Customs requirements
http://www.nzembassy.com/papua-new-guinea/going-to-new-zealand/customs-requirements


Technical standards - Medical devices
http://www.unicef.org/supply/index_52841.html

The Study Programme for the Pharmaceutical Affairs Experts
November, 2009, Tokyo, Japan
Country Reports
http://www.jicwels.or.jp/files/CountryReports_100318.pdf

 

[somashekar]

Re: Papau New Guinea Medical Device Regulations

PAPUA NEW GUINEA - Department of Health
http://www.health.gov.pg

This link does not open and so very unfortunate ...

Can anyone help with this url ?

 

[MIREGMGR]

Google indicates that this is a good URL. Apparently the server is stalled at the moment, but it's been online recently enough that it's still in the DNS.

 

[chloep17]

Thank you for the very useful links, it's unfortunate that the Ministry of Health Website is not available. Do you think that this is a temporary problem?

 

[MIREGMGR]

It appears to me that the server actually is responding, but is serving a blank page.

So, I'd assume this is a temporary technical problem.

 

[sweetasheaven]

Hi guys went through all the guidelines but there is no information. can some kind soul shed some light? need this information urgently.

Thanks!

 

[Ronen E]

Hi guys went through all the guidelines but there is no information. can some kind soul shed some light? need this information urgently.

Thanks!

No information?...

Maybe a little outdated, but this link seems to have some...

 

[sweetasheaven]

Thanks for the kind reply. I went into the link but there is also nothing much concerning the registration route and requirements. It seems that there is annex of devices that is procured for the country's need.

The link only show what is required on the label and advertisement control.

 

[Ronen E]

In countries such as PNG it is likely that the requirements are quite minimal. Unless there's a clear indication that there's an additional, significant body of requirements somewhere else, I would assume that that's it.