Q：How to manage the product about breast implants which are filled with silicone?
A：
(1) Due to doubts of the safety about breast implants which are filled with silicone, TFDA announced the prohibition against the import, manufacture and sell on September 9, 1992. While TFDA is deliberating the situation of existing products technological development and relevant international management trends, it announced that breast implants filled with cohesive silicone did not belong to the usage of prohibition above in October 3, 2008. However, it should apply for registration to ensure the safety and effectiveness of marketed products.
(2) The indication of this kind of product is only for "women to do breast reconstruction surgery."
(3) In order to protect public health and safety of usage, the introduction for use (IFU) of product will attach" breast implants filled with the cohesive silicone– notice for patients before reconstruction surgery ". Physician will be asked to explain and communicate with patients fully about the potential risks and complications that might occur before surgery, and it should do the signature of both the patient and the physician.
(4) It’s better to put breast implants filled with cohesive silicone inclusion of drug safety assessment tasks and to require pharmacists to submit the safety information every half a year about the domestic usage of the product and latest news of the domestic and foreign adverse reactions to protect public safety.
Q：What’s the situation of "Standard of good clinical trial for medical devices" currently?
A：
(1) TFDA announced the "Standard of good clinical trial for medical devices" on May 30, 2007.
(2) It commissioned the project called "The training of audit personnel with clinical trials and audit matters of medical devices" to match up “Standard of clinical trial for medical devices” that the registration need and to ensure the process of testing is complied with ethics certainly, and the testing data of results are correctly credible.
(3) It commissioned the project called "The training of medical personnel with clinical trials of technique and audit matters of medical devices" via the educational course about clinical trial which can foster the professional ability of medical personnel and researcher. This project can build a good environment of clinical trial.
(4) The review system of clinical trial of medical devices case has been established gradually. When medical institutions are in the implementation of human testing case, there are some norms to follow the settings and operations of laboratories. Not only can shorten the period of preparation of the case in order to accelerate the development of domestic biotechnology industry but also can improve the quality of human testing by regulations with certificate of audition.
Q：How to classified and graded the common dental clinic equipment, such as dental clinic chair, high speed, drills and dental surgery shadowless light?
A：Guidelines are determined in accordance with the grading regulations in the Regulations Governing Management of Medical Devices. Basically refer to the regulations settings by FDA. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm)
(1) Dental clinic chair- Belonging to F. 6250 dental clinic chair and attachment as the first level of medical equipment.
(2) High speed, drills- Belonging to F.4200 dental device and attachments as the first level of medical equipment.
(3) Dental surgery shadowless light- Belonging to F.4630 dental surgical lights as the first level of medical equipment.
These three products is also classified as CLASS I in the United States
Q：There’s a medical device which is classified as the first level currently. Our company proposes a strict management that it should be promoted to the second level. Which organization can accept my proposal?
A：TFDA commissioned ITRI Center for Measurement to execute the research project about classify and grade of medical devices. It is welcome very much that everyone propose their recommendation about classification and grading of medical devices. Others like the public, association, academy can word to TFDA.
ITRI Center for Measurement contacted as follows:
Tel: 0800-45-8899 or 03-5743881
Fax: 03-5743092 or 03-5732299
Email Address: senwork@itri.org.tw
Address: Rm. 300, 16Department, No.321, Sec. 2, Guangfu Rd., East Dist., Hsinchu City 30011, Taiwan (R.O.C.)
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