Manufacturers can get earlier access to the market under a new pilot program launched last week in South Korea that unifies the country’s medical device approval review process and the health technology assessment.
The new process, called the Integrated Service for Medical Device Approval and Health Technology Assessment, will be offered until July. The program will be rolled out fully after revising relevant regulations based on the result of the pilot.
Under the program, companies can proceed to HTA at the same time that they are in the process of seeking regulatory approval. Previously, companies couldn’t submit applications for HTA until they had product approval, says Young Kim, president of Synex, a professional service firm for healthcare businesses in Korea.
“HTA took 9 to 12 months previously, so companies can save such significant amount of time to market under the new program,” Kim tells IDDM.
The country’s former program, called HTA One-Stop Service, also reviewed HTA, approval and existing technology determination process simultaneously. However, it lacked active cooperation among the ministries, which caused discrepancy in evaluation results between Ministry of Food and Drug Safety and the Ministry of Health and Welfare, creating confusion for companies.
Under the pilot program, companies will receive a single integrated result reflecting both review processes. If the technology is identified as existing technology, it will proceed with general approval process, not the integrated process.
A product accepted to the integrated service receives a final result within 120 days after submission, within 80 days for emerging technology, and within 240 days for the applications other than IVDs or those that need additional review time. Even when a company receives conflicting results in the approval and HTA review process, it can get the final results quickly by only submitting additional information.
The program also offers companies a better chance of success in both regulatory approval and HTA, since MFDS is supposed to take the leadership role in harmonizing the review criteria for the agency’s regulatory approval and the HTA agency’s approval before companies can proceed with the government for reimbursement/self-pay approval, says Kim.
“Previously, many device companies had regulatory approvals but failed in HTA, as HTA required a significantly higher level of clinical evidence than the one for regulatory approval. As a result, device companies had regulatory approval but could not launch such devices commercially,” she adds.
In Korea, HTA is mandatory for devices introducing a new medical procedure before they can be introduced to market, Kim explains. Under the new program, MFDS is expected to communicate closely with the HTA agency to narrow down the gap in the level of evidence between regulatory approval and HTA. — Jonathon Shacat