Marcelo Antunes It depends on the regulatory system.

I bet Landon Lack, Kirk Zeller, Arthur Brandwood, and Ames Gross know the answer.

In China there is a difference between the local license holder and the local entity that submits the registration application. In most other markets in Asia, those responsibilities fall to the sale entity.

Great question. I’ve done this about 150 times over the years


1. In the end the manufacturer is responsible- they have the overriding interest.

2. Many times we shift the responsibility to the distributor because we want to save costs (if we are expending into 20 countries ) and because the distributor knows the specific issues of the country and should have relationships in place to facilitate and accelerate the registration

3. If the distributor does registration he has you by the, pardon the expression, short and curlies. In most countries if a partner carries out and pays for registration you are locked into that partner for ever.

Karen Boyd, ASQ CQA Thank you! Looking at China and Mexico.

Arthur Brandwood Bryan - in China the license is actually issued in the name of the manufacturer - although there's a process where the physical license (piece of paper) is handed to the applicant - who is the local agent. Many distributors if given the regulatory agency use this to mislead manufacturers into believing that they (the distributor) own the license. Without the physical copy it takes a bit more time to get the agency changed - but it can still be done. (In our consulting practice we ALWAYS deliver the physical license back to the manufacturer client by the way).

Under proposed tighter laws in China slated for later this year, the agent will be responsible for all comms with CFDA (pre- and postmarket) as well as taking direct product liability and responsibility for after sales service. So local regulatory services are going to get a lot more tightly policed, contracts for who does what will need to be well considered and choice of partner ever more important.

Arthur Brandwood .. and also - it's possible to have a separate entity to the distributor (e.g. a reg consultant) handle regulatory in e.g. China, Taiwan, Japan, Australia, India, Korea and much of ASEAN.

How about indonesia country?

Karen Boyd, ASQ CQA Besides being out of the loop of overseas regulatory req's for a couple years, my question is also to identify if it's worth or necessary for a manufacturer to utilize a consultant in addition to having the agent in these countries. The manufacturer is desiring more control over registration and favors not utilizing distributors - for reasons Zach spoke about. Is it better to have direct manufacturer to agent relationship or consulting party between manufacturer and agent? (Granted a consultant will always want business; I understand and relate to that aspect. However, if it's unnecessary, then I'd like to advise in best economical interests.) Thanks again!

Marc Weiser Zach put it best. I have a collection of horror stories that were the result of my company putting it on the distributor to register our products so we could "save" money. I put save in quotes because it ended up costing us lots of money in regulatory expense and lost sales time to fix the situations later.

Arthur Brandwood Hi Karen, Joe,

In almost all cases, regulators require a local legal entity to take responsibility for communications with the regulator and ensuring that the various legal requirements are met. That's not the same as the local agent being required to do it all themselves.

For dossier preparation, In practical terms this is a partnership. The local regulatory agent knows what the local requirements are, the manufacturer actually holds the information in their Technical files.

Usually the agent advises the manufacturer on what's needed and then the parties together work out the most practical arrangements for them to get a finished dossier prepared and into the hands of the regulator. Given this also involves things like notarization and translations (and verification of those translations) this needs to be a process that's clearly worked out and understood between both partners and planned for - otherwise the logistics can introduce some nasty surprises and slow things down.

Tanveer Khan It is the manufacturers call

In China my advice is to keep the regulator agent and local distributor separately .

Karen Zhou Based on my experience, it is the in-country authorized representative ( a local distributor or a third-party agent such as a consulting firm) that puts together the regulatory submissions, in the language of that country. If you read the particular regulations of the jurisdiction, it is usually defined who is responsible for what requirements. The authorized representative is also responsible for post-marketing requirements such as complaints/recalls and has to file this information with the local authority. Initially, the manufacturer usually presents a quality certificate such as ISO 13485 and fills a quality document with a description of the manufacturing facility. It then presents device-specific information such as a licence from the original issuing authority as well as performance data and IFU. This information will vary depending on the jurisdiction.

Grace Fu Palma I just had multiple meetings with CFDA in Beijing. Our Beijing office has assumed the responsibility of the local legal agent for US manufacturers. If funding is not the issue, hire a regulatory firm that provides both like www.ChinaMedDevice.com. If budget constrained, we can find partner for you to fund and handles the distribution.

Grace Fu Palma I agree with Bryan. As a CFDA regulatory service provider with the legal agent certificate, we can provide the turn key solutions of obtaining CFDA certificate and giving the original to the original manufacturer. No need to involve a local sales distributor. Any dealer the factory authorized to sell can sell in China with the approved CFDA certificate. Now CFDA is splitting into 12 divisions from the current 6. Hope it will help to expedite the approval process.

Grace Fu Palma I agree with Bryan. As a CFDA regulatory service provider with the legal agent certificate, we can provide the turn key solutions of obtaining CFDA certificate and giving the original to the original manufacturer. No need to involve a local sales distributor. Any dealer the factory authorized to sell can sell in China with the approved CFDA certificate. Now CFDA is splitting into 12 divisions from the current 6 to be more in line with the clinical applications. Hope it will help to expedite the approval process.

Anthony Zelinko Its the Manufacturer in my opinion for a number of Reasons.

Julie Omohundro Global regulatory harmonization has a long way to go before we can speak meaningfully of what is required for "a country." If an individual country requires one or the other, than there you go. If it doesn't, then it's not a compliance question, but a business decision, and the answer will depend on many variables.

Brian T. Kenney China has specific registration protocols. If the distributor in China is to maintain full control of the license to distribute the product, they will pay for the registration costs. If you desire to change from the present distributor to a new one, it can take years to migrate. Good Luck

Brian T. Kenney China has specific registration protocols. If the distributor in China is to maintain full control of the license to distribute the product, they will pay for the registration costs. If you desire to change from the present distributor to a new one, it can take years to migrate. Good Luck