MFDS amends medical device permit renewal regulations

Will focus on the organizing products in distribution during 1st renewal, and conduct a comprehensive review of safety and effectiveness during 2nd renewal period

The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) issued a pre-announcement of administration on September 6th regarding the amendment of the ‘Regulations on Renewal of Medical Device Manufacturing Permits.’ and will be receiving opinions until September 26th.

 

The amendment contains changes such as requiring different data submissions for each medical device in consideration of each device’s characteristics to ensure the smooth operation of the medical device product renewal system that will be implemented in 2025.

 

The medical device permit renewal system was introduced to periodically check the safety and effectiveness of products that have already been approved, reported, and certified, and requires companies to submit the latest safety and efficacy data, manufacturing and import records, etc.

 

every 5 years to the MFDS.

 

After the MFDS review, companies can continue manufacturing or importing their devices.

 

The main contents of the amendment made are: ▲reasonable application of data submission requirements according to the characteristics of each medical device subject to report production and import discontinuations, etc.

 

▲focus on maintenance of distributed products during 1st renewal, and full-scale comprehensive review of safety and efficacy during 2nd renewal.

 

For ‘reported products' that are relatively low risk to the human body and medical devices that must submit production/import discontinuation reports because a stable supply of such is necessary for patient safety, companies would need to submit a declaration of conformity as proof that it had reflected the latest standards.

 

Also, ‘maintenance products’ that do not require the application of the latest standards due to discontinuation, companies will only need to submit production/import performance records and safety information measures.

 

In the first renewal period (2025-2029), the government plans to focus on reorganizing the products already in distribution, including reorganizing product names and grades to conform with the current regulations.

 

In the second renewal period (2030-2034), the government plans to reflect the latest standards and comprehensively review the safety and efficacy of medical devices, including safety information actions details made by companies, etc.

 

Also, to increase industry predictability, the renewal application deadline will be clearly defined as 270 to 180 days before the expiration date of the validity period, and specify that safety information and action details that have already been reported (submitted) do not need to be submitted separately.

 

The MFDS had held continuous meetings to listen to opinions in the field on ways to improve the industry's predictability and acceptance of the new system and has actively reviewed the opinions for the amendment.

 

The MFDS said that it expects the new amendment to support the rational operation of the medical device product permit renewal system based on regulatory science and expertise, and stated that it will continue to make efforts to create grounds for the public to use medical devices with greater peace of mind.

 

Opinions submitted during the administrative notice period will be actively reviewed and reflected if necessary.

 

For further information regarding the amendment, please visit the Ministry of Food and Drug Safety’s website (http://mfds.go.kr > Laws/Data > Legislation Data > Legislation/Pre-Announcement of Administration) for review.