Medical Device Secondary Packaging Facility - Regulatory Compliance Requirements?

[Nidhi V]

Dear All,

I'd like to know the regulatory requirements (with acceptance at a global level) for a facility where only secondary packaging of a non sterile, CE certified medical device would be carried out.

Would appreciate any inputs and guidance on this. I have been trying to reach a firm conclusion based on the interpretation of several guidelines, but I need confirmation from "real- life experiences" !. As I understand it so far, the requirements are not as stringent.

Thanking you,

With regards,

Nidhi.

 

[DrM2u]

Re: Medical Device Secondary Packaging Facility - Regulatory Compliance Requirents?

Uh ... Do you sell the packaged product directly (or through distribution channels) to the market or to a customer who then sells it (i.e. the packaging is an outsourced process for your customer)? If you sell to a customer then your customer should tell you what the regulatory and/or customer requirements are. If you sell to the market then the applicable regulatory body should tell you what the requirements are. In US it could be ISO 9001, ISO 13485 and/or FDA CFR 820, to name a few.

 

[MIREGMGR]

Re: Medical Device Secondary Packaging Facility - Regulatory Compliance Requirents?

Assuming that your customer is the maker of the products, the presence of their CE Mark on the product means that they are regulatorily responsible for it.

As a contract packager and/or kit-packer for them, you won't have any direct regulatory responsibility. Your customer(s), though, may impose contractural requirements on you, so that your output will be consistent with their responsibilities. They may have the same concerns that would apply if your operations were owned by them...procedurization, management systems, consistency, cleanliness, supplier controls, qualification of materials and methods, etc.