Medical Device Regulations in Pakistan

Good Afternoon All,

Firstly I'd like to say what a resource that Elsmar is. It has helped me a huge amount with regards to worldwide medical device regualtions!

However, I have another one for you.

I am trying to investigate the current Pakistan Medical Device regulations. Whilst I do not believe that there are any specific regulations as of yet - and my hours of research seem to back this up - I have have found a Private Members Bill introduced to the National Assembly of Pakistan. It is a dedcated set of medical device regulations and was introduced in 2008. However my question is this: does anyone know if and when this bill will be voted upon of introduced as law in Pakistan?

Any help would be greatly appreciated,

Paul

Hi Paul,

Sometime back I found the attached from ITA website.
I hope this could be of some help to you.

I am not sure of such bill. However, I believe the information is still active, although its of CY2000.

In most of the South Asian and SEAsian Countries, although government has implemented (or trying to implement) medical device regulations, but due to lack of control, the distributors are not willing to spend money on registrations and distributing in the market without registration. So foreign manufacturers who wish to enter into such markets are not getting enough visibility of presence of regulations. Recently, in SriLanka, when I called the Authority, they confirmed everything (medical devices) has to be registered; however the agent has communicated a different version.

Anyway, I'l try to get the latest info for Pakistan soon.

Regards,
Sreenu

Good Morning Sreenu,

Thank you for you post and information, it was very helpful. One think that I have realised whilst researching for global medical device regulations is the number of countries where regulations are required, and yet to be fully implemented! (The lack of me being able to read multiple languages is another hurdle .....).

With regards to Pakistan, the other small issue is accesing various websites from outside pakistan - it takes a very long time and using the cache files in some cases. Unfortunately, I cannot post the links as I am still a newbie to the forum, however the medical device regulations are available from the National Assembly (google 'Pakistan National Assembly') and are located under Private Members Bills.

Again, thank you for your time,

Paul

Hi PFD2010..

Thank you very much.

Further to that, I have the latest and clear information for Pakistan regulations.
1. Drug Control Organization is the Regulatory Authority; HQ: Islamabad.
2. Pharmaceuticals+medical devices are under Pharmaceutical(s) Regulations.
3. Regulations are in Drug Act 1976. As per the Act, some products that are traditionally considered as medical devices are classified as Drugs.
There are no medical-device specific regulations implemented in Pakistan; however, medical devices mentioned in the Act are treated as drugs and therefore subject to the drug regulations. And Med devices that are not covered in the Act are NOT required to comply with any regulations.
4. No classification of devices.

Regards,
Sreenu

Thanks Sreenu, your posts are much appreciated

Hi Sreenu

Any update on the Medical Device Regulation in Pakistan?
Thanks for your help!

nrsching

Dear all,

Does anyone has any updates on the current status of the Medical Devices Regulation for Pakistan?

Thank you in advance!

Ocean. J

Ocean J said:

Dear all,

Does anyone has any updates on the current status of the Medical Devices Regulation for Pakistan?

Thank you in advance!

Ocean. J

Click to expand...

Welcome to the Cove, Ocean J

Pls note that I have deleted your duplicate post. Posting the same question in two different sections will dilute the chances of getting good response.

Refer to Drug Regulatory Authority of Pakistan for more details.

Hi All

I have checked all the references in this post and other related posts but I am unable to find the source legislation or even official guidance on which medical devices have been regulated as drugs.

The particular device I am interested in is a sterile cannula.

I have also found a web article which indicates, through


I am unable to locate these SROs to confirm this review.

Is anyone able to provide a direct link to any of these SROs?

And/or confirm that cannulae require registration in Pakistan?