INSIDE CHINA: Changes to medical device regulations and hints for the future

Screen Shot 2013-10-18 at 11.30.07 AMIn the latest Inside China column, Michael Alper of NeuvoMedica details changes to China’s medical device regulation, and how the latest legislation might hint at future amendments 

April 2014: Inside China -Changes to medical device regulations and hints for the future

Recently, China’s State Council released the much-awaited updated “Regulations for the Supervision and Administration of Medical Devices” with a set date of 1 June 2014 to officially commence enforcement.  This is the first update since January 2000 and sets the framework for how medical devices will be governed in China going forward.

The new regulation contains some very clear changes from past legislation.  However, much of the changes are subtle and act as a framework hinting about the direction of future, more detailed legislation. Also, some of the document clarifies and sets what has already been common practice in recent years, or has already been clarified in other enacted laws.

One of the major concerns with the new legislation has been around the requirements for domestic clinical trials of imported medical devices.  Though the new regulations specifically mention the requirement for clinical trials for Class II and III devices, such verbiage was already included in the 2004 “Measures for the Administration of Medical Device Registration.”

The new regulation does not specifically mention where the clinical trials should occur but does outline certain conditions in which a clinical trial would not be necessary, such as if similar devices have been on the market for a long time with no safety issues, or if it were possible to prove the safety of the product without a clinical trial, for example.  Also, it states that the China Food and Drug Administration (CFDA) will create a catalog listing devices that can avoid a clinical trial that will be updated and made public.

However, this does not mean the concern related to domestic clinical trials is no longer an issue.  A new “Measures for the Administration of Medical Device Registration” is expected to be issued in the near future which should clarify the need for clinical trials in more detail, including whether or not they need to be local.

One major change to the regulation that is both a benefit to local entrepreneurs and foreign medical device companies is around getting approval for a locally manufactured medical device.  Previously, a company needed to get a medical device manufacturing permit before it could get a product approved.  To get such a permit requires building a factory and employing individuals.  Thus a company would need to support the cost of a manufacturing plant while waiting for device approval, which can take several years.  The new policy allows for companies to get device approval before getting the permit thus saving a significant amount of time and money.

Classification of medical devices has been redefined in the policy officially as based on risk, which should be specifically evaluated based on intended use, structural features, method of usage and other factors.  There is already a catalog of medical device types with their related classification.  The new policy might cause a reshuffling of this catalog with devices being reclassified in other categories.  It might also allow for more flexibility, with some products previously classified in higher-risk categories to be reclassified into lower-risk categories as the technology behind the product becomes more mature.

In addition to classification, handling of how lower-risk medical devices are regulated has changed.  In the past all companies selling medical devices in China required a special license.  Now only those that sell Class III products require such a license. Companies selling Class II devices need just file their activity with the government.  There is no longer any requirement for selling Class I products.  Also, the requirement of registration for Class I devices has been removed.  Instead Class I devices will be managed on a filing basis.  This new handling of lower-risk medical devices will reduce some of the regulatory overheads for companies.  Additional reduction in burden includes the clause that CFDA registration certificates are now valid for five years instead of four; reducing the amount of times that re-registration will be required.  Finally, a change in a manufacturing site no longer requires a product re-registration.  Instead, only a filing with the CFDA is required.

Next, the regulation has added a lot of verbiage related to recalls, adverse events and post-market surveillance.   Though much of this has been covered in previous legislation, the fact that it is specifically clarified in this regulation at the State Council Level signifies the importance that the government will place on these topics.  This goes along with the government’s overall focus on improving the quality and safety of medical devices in China.

Finally, the regulation clarifies and adds stiffer penalties for lack of conformance with medical device laws and regulations.  In the past penalties were based on the manufacturers’ profit, whereas the new regulation bases it on product value, making it easier for the government to enforce.  Additionally, penalties have increased from 2 to 5 times (profit) to 5 to 20 times (product value), significantly increasing the cost of breaking the law.  Finally, the new regulation adds fines and blacklisting to manufacturers, testing centers and clinical trial sites so that for serious violations, such entities will lose their license and be unable to manufacture, test or conduct clinical trials for five years (manufacturers) or 10 years (testing centers and clinical trial sites).

Companies dealing with medical devices in China should familiarize themselves with the new regulation and determine how it affects their business and business strategy.  As more legislation is expected in the near future, companies should remain vigilant and be ready to adjust to future changes.

On April 25, 2014, posted in: News by

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