Hello, thank you for the informative video! May I ask if the hyperlink you mentioned for country specific requirements were provided? Can't seem to find it, thank you!
Hello, Iv’e been binge watching your videos, they are very helpful. if I may ask. if i go with a private label for a medical device whose manufacturing is outsourced. Is mdsap audit for my company or the outsourced company? appreciate it if you can answer my question.
Thank you for watching, and I love the comments. Private labeling is a topic people ask about all the time. As a thank you to you, and everyone else that has asked so many questions about private labeling, I'm going to dedicate our next CZcams live streaming to the topic. Your particular questions needs some qualifiers or assumptions before you can answer it. The primary reason is that the "private label" requirements are different in every country. Your question was about MDSAP certification audits specifically. The MDSAP certification is a variation of ISO 13485:2016 certification that is only required by Health Canada for Canadian licensing. In the USA, the FDA allows people to "private label" in two different ways: 1. "Distributed by" or "Manufactured for" may be used on the label...in this case you are not the manufacturer and you are not the specification developer. You might be the initial importer, complaint file establishment, and distributor. Of the 3 roles, only the distributor is exempt from the registration with the FDA. None of the 3 roles require MDSAP or even ISO 13485 certification in the USA. For the role of initial importer, you have regulatory reporting responsibilities. For the role of complaint file establishment, you have the responsibility to create and maintain complaint records, but the corrective actions would probably be the responsibility of the manufacturer. For the role of distributor, you are responsible for maintaining records of distribution--in case of a potential recall. A full quality system is not required for any of the 3 roles. 2. If you are receiving bulk product from the manufacturer/specification developer, and you are repackaging/relabeling the product, now you will need to add this role to your registration with the FDA. As the repackaging/relabeling company, you must have a quality system, but there are some procedures required in 21 CFR 820 that will not be applicable to your company. Your design control activities will be limited to the label, and in some rare cases the repackager will be placing the product in a sterile barrier package and sterilizing the product. This is more common for kits containing class 1 devices, but I've seen it for class 2 devices as well. If you take on sterile packaging and sterilization you are now doing 90% of the quality system requirements yourself. As I said, MDSAP is not "required" but if you have MDSAP certification, the OEM is a supplier you outsource to. If they have ISO 13485 certification, they probably will not need to be audited by your certification body. Instead you just show your supplier agreements and supplier evaluation of the OEM--along with a copy of their ISO 13485 certification. There are many other possible scenarios, but please schedule a call with me using the contact us page on our website, and I will try to answer the question as it pertains to your specific scenario. Also, please check our our CZcams live-streaming on April 12.
Yes you do. Each country requires a separate registration process. For the USA, you will need a US Agent, for Canada a regulatory agent is optional, for Brazil you need a license holder, for Australia you need a sponsor (usually your distributor), and in Japan you need a MAH. If you need help, our firm offers US Agent services and we can help you navigate the other countries. Just schedule a call with us using the contact us links on website.
Hello, thank you for the informative video! May I ask if the hyperlink you mentioned for country specific requirements were provided? Can't seem to find it, thank you!
Country-specific requirements are at the end of every single task in the MDSAP audit approach: www.fda.gov/media/166672/download
Hello, Iv’e been binge watching your videos, they are very helpful. if I may ask. if i go with a private label for a medical device whose manufacturing is outsourced. Is mdsap audit for my company or the outsourced company? appreciate it if you can answer my question.
Thank you for watching, and I love the comments.
Private labeling is a topic people ask about all the time. As a thank you to you, and everyone else that has asked so many questions about private labeling, I'm going to dedicate our next CZcams live streaming to the topic.
Your particular questions needs some qualifiers or assumptions before you can answer it. The primary reason is that the "private label" requirements are different in every country. Your question was about MDSAP certification audits specifically. The MDSAP certification is a variation of ISO 13485:2016 certification that is only required by Health Canada for Canadian licensing.
In the USA, the FDA allows people to "private label" in two different ways:
1. "Distributed by" or "Manufactured for" may be used on the label...in this case you are not the manufacturer and you are not the specification developer. You might be the initial importer, complaint file establishment, and distributor. Of the 3 roles, only the distributor is exempt from the registration with the FDA. None of the 3 roles require MDSAP or even ISO 13485 certification in the USA. For the role of initial importer, you have regulatory reporting responsibilities. For the role of complaint file establishment, you have the responsibility to create and maintain complaint records, but the corrective actions would probably be the responsibility of the manufacturer. For the role of distributor, you are responsible for maintaining records of distribution--in case of a potential recall. A full quality system is not required for any of the 3 roles.
2. If you are receiving bulk product from the manufacturer/specification developer, and you are repackaging/relabeling the product, now you will need to add this role to your registration with the FDA. As the repackaging/relabeling company, you must have a quality system, but there are some procedures required in 21 CFR 820 that will not be applicable to your company. Your design control activities will be limited to the label, and in some rare cases the repackager will be placing the product in a sterile barrier package and sterilizing the product. This is more common for kits containing class 1 devices, but I've seen it for class 2 devices as well. If you take on sterile packaging and sterilization you are now doing 90% of the quality system requirements yourself.
As I said, MDSAP is not "required" but if you have MDSAP certification, the OEM is a supplier you outsource to. If they have ISO 13485 certification, they probably will not need to be audited by your certification body. Instead you just show your supplier agreements and supplier evaluation of the OEM--along with a copy of their ISO 13485 certification.
There are many other possible scenarios, but please schedule a call with me using the contact us page on our website, and I will try to answer the question as it pertains to your specific scenario.
Also, please check our our CZcams live-streaming on April 12.
Thank you so much for taking the time to reply. Very informative and i look forward to your video on april 12.
Hi sir, after getting MDSAP certificate, do we have to do product registration as per country wise ? Kindly guide me...
Yes you do. Each country requires a separate registration process. For the USA, you will need a US Agent, for Canada a regulatory agent is optional, for Brazil you need a license holder, for Australia you need a sponsor (usually your distributor), and in Japan you need a MAH. If you need help, our firm offers US Agent services and we can help you navigate the other countries. Just schedule a call with us using the contact us links on website.
@@MedicalDeviceAcademy thanks sir, if required we will contact you in future...