Korea adds one-stop review for hearing aids, implants

The food and drug safety ministry said it has begun allowing makers of hearing aids and dental implants to file technical-document review and product certification in a single application, shortening a process that had run about 40 days to 25.

Under the previous two-step system, manufacturers had to obtain a technical-document review from a designated review agency, then submit the resulting report when applying to the Korea Medical Device Safety Information Service for certification. Applications for both can now be made together at the information service.

A pilot run of the combined procedure cut processing to 21 days for new certifications, according to the ministry. The one-stop route is limited to Class 2 medical devices, the category that covers products used most closely in daily life, including the two device types named by the ministry.

The ministry announced the change on Sept. 14, when it gave notice of a revision to the enforcement rules of the Medical Device Act covering one-stop certification and review of Class 2 devices. It decided to put the revision into effect immediately through active administration, citing the goal of shortening the time it takes to bring products to market so patients can obtain treatment sooner and companies can become more competitive.

The ministry said the revision is intended to secure patients' access to treatment and to strengthen the competitiveness of manufacturers by cutting the period before a product reaches the market.