More than for most businesses, shortening the time needed to bring a new product to market is vitally important for medical device companies. Given the industry’s rapid development of new technologies leading to steady improvements in functions and materials, the existing models of many devices are soon obsolete, ready to be replaced by next-generation products.
Manufacturers do their best to reduce the time to market, but one of the most important factors is beyond their control: the length of the regulatory process for first auditing the production facility and then licensing the new product itself.
Members of the industry were therefore gratified some years ago when Taiwan introduced a simplified Qualified System Documentation (QSD) approach for the first stage of that procedure. Instead of sending a team overseas to inspect the factory, the Taiwan Food and Drug Administration (TFDA) began accepting a document called an Establishment Inspection Report (EIR) from its counterpart, the U.S. FDA, for facilities located in the U.S.
In recent years, however, that method has no longer worked smoothly due to changes in U.S. FDA practices. The U.S. regulatory agency adopted a risk-based management approach that called for far fewer physical inspections. As a result, companies seeking to utilize Taiwan’s simplified pathway were often unable to obtain an up-do-date EIR to meet TFDA’s requirement.
For the past four years, the Medical Devices section of each edition of AmCham Taiwan’s annual Taiwan White Paper has urged the TFDA to respond by adopting an alternate auditing procedure. Since 2016, the U.S. FDA has joined with regulatory bodies from Australia, Brazil, Canada, and Japan in participating in the Medical Device Single Audit Program (MDSAP) developed by the International Medical Device Regulators Forum. The Medical Devices Committee called on the TFDA to recognize MDSAP audit reports as a substitute for EIRs.
Besides being raised each year in the White Paper, the issue was also regularly on the agenda for U.S.-Taiwan trade negotiations, most recently at the resumed bilateral Trade and Investment Framework Agreement Council meeting (TIFA talks) in June this year. As a follow-up to that discussion, the TFDA on October 20 announced that from 2022 it will accept MDSAP reports as sufficient to qualify an applicant for the expedited pathway for licensing a new medical device.
“This was an extremely welcome development,” says Louis Ko, general manager of Johnson & Johnson Medical Taiwan Ltd. and co-chair of AmCham’s Medical Devices Committee. “It should enable us to reduce the registration time from 9-12 months to 3-6 months. Getting products to market faster means giving patients access to the latest technologies and treatments.”
In a video presentation to AmCham Taiwan’s recent Annual General Meeting, American Institute in Taiwan Director Sandra Oudkirk applauded the TFDA announcement, citing it as a prime example of how trade talks can help resolve longstanding issues.