One of the most important considerations device manufacturers will make before entering China is whether the device will be manufactured locally or not.
Deciding to manufacture abroad — either at a facility or a contract manufacturer — will require having a registration agent to be a liaison with the China Food and Drug Administration.
That agent will help with registration, regulatory compliance and postmarketing surveillance activities, said John Balzano, special counsel for law firm Covington and Burling, during a recent FDAnews webinar. Most companies will also need a separate regulatory consultant as well.
Over the last eight or so years China has been reforming its device regulations. In the last few years, the country has been actively pursuing innovation, and new regulations reflect that stance. In its 13th five-year plan, there are multiple national-level initiatives to improve scientific innovation, research and development.
To that end, the government is encouraging companies to bring their manufacturing operations to China, mostly because it will help its own domestic industry to evolve.
“Overall, they’re going to want to make sure that they have a regulatory structure in place that facilitates the most innovative applications and the applications for devices that are meeting what China considers to be its unmet medical needs, Balzano said.
“If you’re domestically manufacturing in China, you’re going to have a product license and then you’re going to have a manufacturing license that goes along with the facility.” Both licenses are subject to GMP requirements.
An imported device has a foreign license holder, and the manufacturing occurs overseas, or part of it occurs overseas, and what’s coming into China is a finished device. For imported devices, companies will need to show that their products are approved abroad, and that they’re operating as device manufacturers abroad.
There are also restrictions on contract manufacturing devices in China, and the contract manufacturing system is fairly complex.
However, the government grants more leeway for innovative devices and is permitting innovators to hold a license and then contract out the manufacturing.
Devices that are accepted under the innovative device pathway gain a number of distinct advantages. To be eligible for the pathway, the intellectual property needs to be held in China, and the device needs to represent an improvement over existing technology and be clinically significant.
Devices that enter the innovative pathway will also benefit from more communications with the Center for Device Evaluation, Balzano said.
Another big advantage is that the company won’t necessarily have to have its own manufacturing license in China. “That is a very significant advantage, because it saves you an additional process,” he said.
Inspections A Big Deal
“Inspections are a big deal, and they have become an even bigger deal since 2014 when CFDA revised its GMP regulations,” Belzano said, explaining that there are licensure inspections, compliance inspections, surprise inspections and self-inspections.
GMPs for medical devices were initially issued in 2009, and they were experimental. Now, however, GMPs are in full force. If you’re applying for a manufacturing license you’re going to have to undergo an inspection before you can have the license.
There are announced compliance inspections that the provinces conduct, and there’s a tiered system of scrutiny of manufacturing enterprises. Unannounced inspections are basically for-cause inspections.
And then there are self-inspections, which are forced self-audits where companies take stock of their compliance over the last few years and submit self-assessments to the local authorities, which are then evaluated by CFDA.
How often companies get inspected is determined by their compliance record.
“Quite often the government is clocking what it sometimes refers to as your credit score, and it’s basing your score on noncompliances, but also the risk that you pose potentially because of the complexity of your product.
“Some devices are subject to enhanced supervision because they’ve had safety issues and sometimes also because they’re just more complex products.”
A new area is foreign inspections, and CFDA has not issued any guidance on how it plans to conduct foreign inspections.
CFDA has always had the power to conduct surprise inspections, and the agency issued comprehensive regulations on these. Suspicions of GMP violations or a significant record of noncompliance can trigger a surprise inspection. — Tamra Sami