Biocompatibility standards in South Korea under revision
MFDS is revising its 「General Standard Specification regarding Biocompatibility of Medical Devices」 (Ministry of Food and Drug Safety Notice No. 2013-64, 2013.4.5) in part, and gathering consensus from the people. See below the purpose, reasons for revision, and key details as following in accordance with 「Administrative Procedures Act」 Section 46.
The international standard regarding the biocompatibility for medical devices that is internationally accepted has been changed in part since the revision of International Standard for medical devices (ISO 10993-4, 9, 13, 16). As a result, it is necessary to advance the national standard by making it to conform to the new international standard for the purpose of enhancing the safety and quality level of medical devices distributed in Korea said the MFDS.
- The current Korean General Standards regarding the biocompatibility of medical devices are not established in the form of provisions and therefore pose difficulties to clearly define the purpose of Standard and the Scope of Application.
- It is necessary to newly draft the Provisions in the texts of Korean General Standard regarding the biocompatibility of medical devices, and to define clearly the purpose of Standard and the Scope of Application.
- It is intended to improve the efficiency of oversee Standard by systematically maintaining contents of the texts regarding the Purpose of Standard and the Scope of Application
There is a concern for the growing possibility, which may lead to confusion on the petitioners and to occurrence of potential risk on the patients, because some parts of test methods are not internationally harmonious with regards to the current Korean General Standard concerning the biocompatibility of medical devices.
The International Standard (ISO 10993-4, 9, 10, 13, 16) of recent medical devices that can be distributed internationally is reflected in that some test standards and methods concerning the biocompatibility of medical devices are changed as per the following:
- the evaluation test methods and examples concerning the blood composition evaluation test medical devices that come in contact with blood are clarified
- A flowchart is added in order to allow systematic test designing for the in-vivo decomposition per each medical device ingredient (polymer, metal, ceramic, etc.).
- Alternative test methods for animal experiments are added in order to evaluate the effects of skin irritation.
- It includes test methods for the effects of skin irritation when using artificial skins that are human-derived, and for the evaluation of eye irritation using bovine eye of the slaughtered cattle.
- Test methods are added to evaluate cracking phenomenon of polymer ingredient (e.g. polyurethane) resulting from the exposure in the chemical and biological environment
- It is clarified that toxicokinetic tests should be considered when there are active ingredients within the biological materials that may be released from biodegradable medical devices.
If any organization or individual wishes to express an opinion on 「Korean General Standard regarding Biocompatibility of Medical Devices」 Limited Revision Notice, they can submit the written opinion with following informations by March 31st, 2014.
To: Minister of Food and Drug Safety
Postal Code: 363-700
Address: Choong-Chung Book-Do Chung-Won Kook Oh-Song Eub
Oh-Song Saeng-Myung 5th Street 303 Kookdo Purumiru Building 4th Floor
Ministry of Food and Drug Safety (Annex)
Re: Medical Device Policy Making Department
Phone: 043-230-0418, fax: 043-230-0400, email firstname.lastname@example.org)
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