Forced into Regulatory Affairs Role - Where do I begin?

[supadrai]

Hi Everyone, I'm new here and have so far found this forum to be amazing with some very detailed information that is difficult to find elsewhere. Seems like you have great members here, and I hope to be in a position to contribute also.

I was hired by my current company to deal with a demerger and, once the project was completed, they kept me on. The company owns a few medical examination glove factories and we are now exporting to 72 jurisdictions or so worldwide. All of our regulatory affairs people went with the company we demerged from, so because I'm a native English speaker and a trained lawyer, they threw it all to me. It's pretty overwhelming and I fear I might be making some serious errors that will affect our ability to sell into these jurisdictions.


I have zero regulatory affairs experience.

Where should I begin? Any advice?

Thank you in advance!

 

[pkost]

Oh dear, that doesn't sound like a pleasant experience, I'm not sure where to get you started beyond recommending you request someone is recruited, or failing that get a consultant in to assist.

The first question I would have is how do you manufacture? Do you hold the licenses/approvals or do your customers? the answer affects the risk and liability to your business

Regardless:

Step 1:
get yourself on a training course on the US FDA or EU MDD (medical device directive - 93/42/eec (soon to be changing to MDR)). I assume you are in both of these markets and they are particularly important to you as a business. Fortunately the concepts between regulatory environments are broadly similar so once you understand one you will start to be able to deduce requirements and expectations of others (i.e. identify areas of significant risk)

Step 2:
As you have a legal background you shouldn't have much difficulty reading the regulations:
Europe regulation 93/42/eec: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

US regulation: CFR - Code of Federal Regulations Title 21 (parts 800-899)

Step 3:
As you have spun out from a parent company I would check and consider whether:
1. You transferred the technical documentation to the new business
2. You registered with all of the jurisdictions with your new details


Questions from me:
Do you still have anyone managing the quality system? (Not someone checking the gloves are good, but the system itself)
Do you have anyone managing complaints and vigilance (reporting of safety issues)
Do you manufacture sterile surgical gloves?

Good news: examination gloves are low risk so you won't be on the radar of too many authorities!
Bad news: with 70 odd markets, something will go wrong sooner rather than later

 

[supadrai]

Thank you so much! All well noted.

The first question I would have is how do you manufacture? Do you hold the licenses/approvals or do your customers?

QMS is managed by the factory and they have an excellent team with a lot of experience over the past 20 years since the first factory opened. That's been a blessing. We hold the licenses for the big markets ... smaller markets are a mixed bag.

Questions from me:
Do you still have anyone managing the quality system? (Not someone checking the gloves are good, but the system itself)
Do you have anyone managing complaints and vigilance (reporting of safety issues)
Do you manufacture sterile surgical gloves?

Quality team seems excellent and while they didn't manage the regulatory in out export markets, they obtained all our certifications and handled all audits. Again, a blessing. Complaints and vigilance is another part of what we lost - so me? No sterile surgical gloves at present.

Thank you again. I love new challenges, just being grumbly.

Working hard to find a good regulatory people. Should have one on board by end of October but that's just the US and Canada. So we will probably need to use some consultants in other markets until they can take on that work.

 

[Ronen E]

I'm happy to assist in whatever you need. I haven't been to Bangkok in a while. Please send me a PM if interested.

I would start with an orderly list of all jurisdictions you sell into, then proceed to identify (high-level) what the regulatory requirements are in each - some probably don't have any, especially for such low risk devices. Then consolidate, prioritise and act. Too easy

Cheers,
Ronen.

PS I loved the advice to "just read" 21 CFR parts 800-899 - that's excellent bedtime material that will serve you well for a while...

 

[pkost]

It's unlikely that you will have any unexpected complaints that present a risk to patient safety however I would anticipate latex reactions being a regular issue; you therefore need to understand your reporting requirements as a priority and be ready to prove your compliance to authorities.

The manufacturer must report some complaints/issues to the authorities in short timescales (immediately without unnecessary delay, 5 days etc) from when they become aware of them. Please consider that countries such as the US require initial importers to report these complaints as well so if they report and you don't it will be obvious!


Don't allow the business to take on sterile gloves until you have a good grasp of everything!


It sounds like there is some regulatory experience in the Quality team; I'd bring them along for the ride!


I'm sure others will contribute with there own thoughts