Does anyone have procedure on "Regulatory Compliance"?

I am tasked to write a high level procedure on “Regulatory Compliance on Medical Devices” for my company at the Corporate level that would state we are in the field of medical devices and list various markets that we serve.

In line with the markets, I will also mention our device listings against the respective facilities and applicable regulations that should be followed in each of the continents viz. America, Mexico, Europe and Asia.

Does anyone have an example ? Also if I could get thoughts on the procedure, that would be great.

Re: Does anyone have procedure on "Regulatory Compliance" ?

I don't think your procedure needs to say much more than something like:

"We ensure legal compliance in the jurisdictions in which we operate by staying up to date with laws in that jurisdiction by subscribing to xyz updating service or regularly reviewing applicable laws in the relevant jurisdiction.

We regularly carry out legal compliance audits in all jurisdictions in which we operate to ensure legal compliance is achieved.

Results of audits reviewed by local and corporate jurisdictional management and required actions are carried out and managed as per the organisations corrective action process."

Re: Does anyone have procedure on "Regulatory Compliance" ?

SGquality said:

I am tasked to write a high level procedure on “Regulatory Compliance on Medical Devices” for my company at the Corporate level that would state we are in the field of medical devices and list various markets that we serve.

In line with the markets, I will also mention our device listings against the respective facilities and applicable regulations that should be followed in each of the continents viz. America, Mexico, Europe and Asia.

Does anyone have an example ? Also if I could get thoughts on the procedure, that would be great.

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I acknowledge that I don't have the detailed knowledge of your operations but I would imagine your procedure needs to say not much more than something like:

"We ensure legal compliance in the jurisdictions in which we operate by staying up to date with laws in those jurisdiction by subscribing to xyz updating service in each jurisdiction or regularly reviewing applicable laws in the relevant countries.

We regularly carry out legal compliance audits in all facilities and jurisdictions in which we operate to ensure legal compliance is achieved.

Results of audits reviewed by local and corporate jurisdictional management and required actions are carried out and managed as per the organisations corrective action process."

hope it helps

Re: Does anyone have procedure on "Regulatory Compliance" ?

Thanks kgott.

I understand your point but I want to use this procedure also to mention our Establishment Registrations, device listing, lit of DMFs etc. in addition to list of regulations across different regions.

Re: Does anyone have procedure on "Regulatory Compliance" ?

"Regulatory Compliance" is the essence of the ISO13485 QMS.
It is more about Understand >> Plan >> Do >> Review and Maintain than about writing a procedure.
As the regulatory is always dynamic with new or revised requirements coming up, the Job discription or the Authorities & responsibilities vested to your regulatory head itself will contain points about Regulatory compliance.
"Regulatory Compliance" is a combination of Product requirement / QMS requirements / Legal requirements.
The best person who can do this is your regulatory person who can write down what all he / she has done so for and why thay were done and towards which region regulatory it meets.
An .xls matrix of Product requirements / QMS requirements / Legal requirements Vs Market regions can be thought of to demonstrate the same at corporate level.

Re: Does anyone have procedure on "Regulatory Compliance" ?

somashekar said:

"Regulatory Compliance" is the essence of the ISO13485 QMS.
It is more about Understand >> Plan >> Do >> Review and Maintain than about writing a procedure.
As the regulatory is always dynamic with new or revised requirements coming up, the Job discription or the Authorities & responsibilities vested to your regulatory head itself will contain points about Regulatory compliance.
"Regulatory Compliance" is a combination of Product requirement / QMS requirements / Legal requirements.
The best person who can do this is your regulatory person who can write down what all he / she has done so for and why thay were done and towards which region regulatory it meets.
An .xls matrix of Product requirements / QMS requirements / Legal requirements Vs Market regions can be thought of to demonstrate the same at corporate level.

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Hi,

I disagree that "regulatory compliance" is the essence of ISO 13485. The essence of 13485, IMO, is best QMS practices for medical devices manufacturers. It can be utilized to meet regulatory requirements concerning QMS for medical devices manufacturing, however full medical devices regulatory compliance involves more than QMS. For example, ISO 13485 addresses some of the FDA's requirements only in a very indirect way.

Cheers,
Ronen.

Re: Does anyone have procedure on "Regulatory Compliance" ?

kgott said:

I don't think your procedure needs to say much more than something like:

"We ensure legal compliance in the jurisdictions in which we operate by staying up to date with laws in that jurisdiction by subscribing to xyz updating service or regularly reviewing applicable laws in the relevant jurisdiction.

We regualrly carry out legal complince audits in all juristictions in which we oeprate to ensure legal complaince is acheived.

Results of audits reviewed by local and corporate jurisdictional management and required actions are carried out and managed as per the organisations corrective action process."

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Hi,

IMO the above can serve as a policy, but hardly as a procedure. The difference is that a (good) procedure is normally detailed and specific, provides useful and concrete instructions and allows objective auditing to.

The above might sound OK for the general industry, but from a heavily regulated industry (like medical devices) perspective it is quite far from being useful or acceptable. I'm sure any auditor would deem it as lacking basic detail - it looks almost like a template waiting to be filled.

Just my humble opinion.

Cheers,
Ronen.

Re: Does anyone have procedure on "Regulatory Compliance" ?

Ronen E said:

Hi,

I disagree that "regulatory compliance" is the essence of ISO 13485. The essence of 13485, IMO, is best QMS practices for medical devices manufacturers. It can be utilized to meet regulatory requirements concerning QMS for medical devices manufacturing, however full medical devices regulatory compliance involves more than QMS. For example, ISO 13485 addresses some of the FDA's requirements only in a very indirect way.

Cheers,
Ronen.

Click to expand...

When the applicable regulatory requirements are stiched well into the QMS of the organization for the continued compliance across the organization and personnel, then the purpose of the QMS is best achieved, and the essence of this is compliance of the applicable regulatory requirements. This is the very reason why 8.2.1 (Customer satisfaction) is replaced by 8.2.1 (Feedback) in the Monitoring and measurement.

For example, ISO 13485 addresses some of the FDA's requirements only in a very indirect way.

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When someone is ISO13485 certified, and FDA is an applicable regulatory requirement, then ISO13485 QMS must assist in meeting the requirements for FDA regulatory purpose entirely. This is what I mean by essence.

Re: Does anyone have procedure on "Regulatory Compliance" ?

SGquality said:

I am tasked to write a high level procedure on ?Regulatory Compliance on Medical Devices? for my company at the Corporate level that would state we are in the field of medical devices and list various markets that we serve.

In line with the markets, I will also mention our device listings against the respective facilities and applicable regulations that should be followed in each of the continents viz. America, Mexico, Europe and Asia.

Does anyone have an example ? Also if I could get thoughts on the procedure, that would be great.

Click to expand...

SGquality,

If your process-based management system already is in place and working effectively it should include a process for "Deploying Legal Requirements" to the documented parts of your organizational management system.

The documented procedure governing this process identifies the agencies and the people responsible for monitoring changes to legal requirements. The procedure would then show what is done to deploy legal requirements and changes to legal requirements to the management system. It would include evaluating compliance and monitoring effectiveness of this process and procedure.

Of course this process would by monitored and corrected or improved as necessary before it is audited for effectivess.

When employees are trained and supervised to use and improve their management system, the organization is assured of compliance with legal requirements (laws and regulations). Indeed, this is the objective of this process and its procedure.

Your global organizational management may currently be a collection of subsystems operating at a national level. In which case corporate could establish a global policy that mandates development, use and improvement of such processes at the national level but imposing a global procedure would not work too well in my opinion.

John

Re: Does anyone have procedure on "Regulatory Compliance" ?

What is the objective of this " high level procedure on ?Regulatory Compliance on Medical Devices?"?