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Logistics and 3PL requirements for medical devices

SGquality

Quite Involved in Discussions
#1
I have read lot of Wholesale Distributor and Third-Party Logistics (3PL) provider requirements for Drugs under the Drug Supply Chain Security Act (DSCSA) applicable for CDER and CBER. Are there any specific regulatory requirements specifically for the medical device industry besides requirements that they have a QMS (Quality Management System), perform internal audits, have a process for CAPAs (Corrective and Preventative Action), process to handle recalls, handle inventory, traceability etc.?

Thank you!
 
#2
Unlike for drugs, there are no specific regulatory requirements for medical device wholesalers or 3PL warehouses. However, there is a general requirement that they should ensure the device is unharmed in any way (temperature, humidity, physical damage, etc). It is up to the manufacturer to specify what level conformity or certification the QMS should have. Any additional requirements should be in a quality agreement. Today a ISO9001 compliant QMS would probably be the minimum.

Under the new EU MDR there are requirements for importers and distributors. the 3PL warehouses may get involved here.
 

SGquality

Quite Involved in Discussions
#5
Thanks for the reference. However that is applicable for the distributors and not the third-party logistics service provider. In my scenario, these 3PL would be an entity that provides or coordinates logistics services of a product in interstate commerce on behalf of a manufacturer or a wholesale distributor, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.
 
#6
The National Associations of Boards of Pharmacy have established an accreditation process for wholesale distributors (VAWD) (see nabp.pharmacy/programs/vawd/) The criteria for accreditation includes a lot of the Drug Supply Chain Security Act (DSCSA) requirements and it applies to both prescription drugs and devices. Please be aware that individual states also have regulatory requirements--if you ship prescription products (drugs or devices) into a state, you need to (in most cases) be specifically licensed to do so by that state and may have other regulatory reporting requirements at the state level to maintain your license. You can review the criteria on line without making any commitment to pursue VAWD.
 
#7
With regards to 3PL, you will still need to follow the requirements of the DSCSA at all points of logistics and distribution. Again, the DSCSA has specific sections that apply to both drugs and devices beyond the one's listed in the original post--how about suspect product? Illegitimate product? Diversion of product? Reporting requirements? Work with the client you are servicing to set the boundaries of what is and what isn't in your scope for regulatory requirements. You may be surprised what they consider to be on your side of the fence.
 
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