Regulatory Open Forum

Hi all--

I'm preparing an application to list our Class A medical device in Pakistan, but I am stumped by what seems like a very basic thing. The application form (Form 6-A) requires that we include "Essential principle of safety and performance." The definitions section of the document (Pakistan Medical Devices Rules 2017, attached) defines "essential principles" as "essential principles of safety and performance of medical device as described in these rules," which leads me to believe that the rules should include a list of Essential Principles that we should fill out and attach to the form. But I can't find such a list!

I have searched the Medical Devices Rules 2017 document multiple times to figure out what the essential principles are that they'd like me to use. I searched the Drug Regulatory Authority of Pakistan website, the Emergo RAMS regulatory repository, did a Google search--nothing! My best guess is that they want us to provide the general IMDRF Essential Principles checklist, but I thought I'd check here in case any of you have experience with Pakistani applications.

Thank you!

Hello Caitlin,

I have not done this personally myself, but I was aware of someone providing format from the IMDRF WG/N47 guidance for Essential Principles which is most similar to Australia TGA and the previous European Union MDD Essential Requirements.  As a note, this was providing in the Tabular Format similar to the EP/MDD "checklist" and did include more information beyond the IMDRF guidance.  Rather than create a new one, they just used the EP/MDD "checklist".  This was done 2 or 3 years ago and believe was accepted.  Sorry I do not have first hand knowledge, but based on experience from my other colleague, would say that is the best approach.

Hi all--

I'm preparing an application to list our Class A medical device in Pakistan, but I am stumped by what seems like a very basic thing. The application form (Form 6-A) requires that we include "Essential principle of safety and performance." The definitions section of the document (Pakistan Medical Devices Rules 2017, attached) defines "essential principles" as "essential principles of safety and performance of medical device as described in these rules," which leads me to believe that the rules should include a list of Essential Principles that we should fill out and attach to the form. But I can't find such a list!

I have searched the Medical Devices Rules 2017 document multiple times to figure out what the essential principles are that they'd like me to use. I searched the Drug Regulatory Authority of Pakistan website, the Emergo RAMS regulatory repository, did a Google search--nothing! My best guess is that they want us to provide the general IMDRF Essential Principles checklist, but I thought I'd check here in case any of you have experience with Pakistani applications.

Thank you!

Hi all--

I'm preparing an application to list our Class A medical device in Pakistan, but I am stumped by what seems like a very basic thing. The application form (Form 6-A) requires that we include "Essential principle of safety and performance." The definitions section of the document (Pakistan Medical Devices Rules 2017, attached) defines "essential principles" as "essential principles of safety and performance of medical device as described in these rules," which leads me to believe that the rules should include a list of Essential Principles that we should fill out and attach to the form. But I can't find such a list!

I have searched the Medical Devices Rules 2017 document multiple times to figure out what the essential principles are that they'd like me to use. I searched the Drug Regulatory Authority of Pakistan website, the Emergo RAMS regulatory repository, did a Google search--nothing! My best guess is that they want us to provide the general IMDRF Essential Principles checklist, but I thought I'd check here in case any of you have experience with Pakistani applications.

Thank you!

In 2019, I did exactly what Richard said.... I submitted the EP/MDD checklist in tabular format (cut and paste) and it was accepted.

Michele K. 

Hi all--

I'm preparing an application to list our Class A medical device in Pakistan, but I am stumped by what seems like a very basic thing. The application form (Form 6-A) requires that we include "Essential principle of safety and performance." The definitions section of the document (Pakistan Medical Devices Rules 2017, attached) defines "essential principles" as "essential principles of safety and performance of medical device as described in these rules," which leads me to believe that the rules should include a list of Essential Principles that we should fill out and attach to the form. But I can't find such a list!

I have searched the Medical Devices Rules 2017 document multiple times to figure out what the essential principles are that they'd like me to use. I searched the Drug Regulatory Authority of Pakistan website, the Emergo RAMS regulatory repository, did a Google search--nothing! My best guess is that they want us to provide the general IMDRF Essential Principles checklist, but I thought I'd check here in case any of you have experience with Pakistani applications.

Thank you!