On September 15, the Ministry of Food and Drug Safety (MFDS) held a public information session for medical device manufacturers and importers to introduce the Biological Evaluation Report (BER), which is a new introduction for the MFDS. The main topics were1) basic information and requirements for BER (e.g., experience and independence requirement of authors, etc.) and 2) guidelines for chemical characterization and toxicological risk assessment methods. MFDS concluded that it plans to harmonize with the international regulatory trend by recognizing international standards on biological evaluation (ISO 10993-1) This, means to accept BER that comprehensively evaluates the possibility of toxicity and history of clinical use of the target medical devices during product approval assessment.

For the above reasons, in November, announced revision plan on regulation for registration/approval of medical device in order to notify relevant parties and collect public opinions. For reference, opinions/input from industry were collected until November 22nd, and the revised details, including biocompatibility will be enforced the first day of 2024 for class 4 products, 2025 for class 3, 2026 for class 2, and 2027 for class 1 products.

 

 ▶Revised Plan on biological Safety Assessment (MFDS Notice No. 2023-516, 2023.11.1)

  – Relevant Excerpts

- Main contents-Expansion of the scope of recognition of data on biological safety: to include data in accordance with the latest international standards (ISO 109993-1:2018) in the scope of recognition of submitted data on biological safety.
(Articles: Article 26 Clause 1 Sub-paragraph 4 Item(b); Article 26 Clause 2); Article 29 Clause 1 Sub-paragraph 5 Item(c), (d); and Article 29 Clause 1 Sub-paragraph 9 Item(a) and (b))

- All items of Article 26 Clause 1, ‘Required Data on Biological Safety’ are to be deleted, and new phrase-Biological safety data can be replaced with BER that comprehensively assesses risk-management-based biological risks based on the physical and chemical characteristics of medical devices according to International Standards (ISO) etc.- is to be added at the end of Article 26 Clause 2.

- Preparation conditions and detailed requirements for BER are stated on Article 29 Clause 1 Sub-paragraph 5 Item(c) and (d), pushing the current item(c) back to item(e).

 

▶Relevant Issues

- The purpose of this revision is to supply safe and effective medical devices to the market at expedited timeline, which may seem to be good news for manufacturers/importers who had difficulties with biological safety testing.

- However, given that, the definition of BER is ‘a comprehensive evaluation of the acceptability on biological hazards and the risk of medical device’. This means, it can be difficult to find the right personnel (to be the qualified author of BER) who have experience in both risk management and biological safety, to conduct ‘comprehensive evaluation’.

- In addition, if a BER refers to previous biological evaluation test results, the manufacturer/importer must verify that the raw materials, level of human body contact (it decides which test to be conducted), and sterilization status of the target product are the same as the test product. If the manufacturer of test product is not the same one, it may be difficult to collect enough data.

- Even if all the requirements are cleared, and a BER is documented by a qualified expert, questions still remain under what standard it will be evaluated.

 

This is a positive movement where the MFDS is trying to be aligned with international standards and systematically re-organize its regulations. However, the improvement and implementation should be more clearly and effectively conveyed in order to avoid any confusion that may be caused throughout the process. If you would like to discuss related matters in more detail or have any other questions, please contact MDREX (pro@mdrex.co.kr) at any time.

Thank you.