Medical Device Act and Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will both be enforced on May 1st, 2021. This article provides an insight into the keynotes of the two regulations.
Medical Device Act
The core value of this act is to ensure the safety, effectiveness, and quality of medical devices. In addition, it aims at improving the management system of medical devices.
There is a total of 85 articles in this act, main points are summarized below:
- 1. Designers and maintainers of medical devices are now considered as part of the production and supply chain.
Designers should take responsibility as a manufacturer of the designed product, while maintainers are regarded as a scope for being a distributor.
- 2. Additional listing and distribution route for low-risk class I medical devices.
Some of the class I medical devices will be advised for listing online and renew their listing annually. Moreover, low-risk medical devices (condoms, hygiene masks, and hot/cold packs), announced by TFDA, can be distributed via vendor machines.
- 3. Medical device tracking
Good Distribution Practice (GDP) should be established following Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License. Manufacturers and distributors should preserve records on the direct supply source. Complete records on the tracking system of medical devices should be kept for at least five years unless the devices are sold directly to consumers.
- 4. Reporting of adverse events in clinical trials.
In order to protect the rights and interests of subjects, all adverse events that occurred to clinical trials should be reported during the study. If a safety risk in the tested medical device was discovered, the clinical trial may be suspended or terminated.
- 5. Post-market safety surveillance.
Certain high-risk medical devices are required to perform post-market safety surveillance. Medical institutions are obligated to provide relevant safety surveillance data to the manufacturers or distributors, allowing them to take the initiative in monitoring medical devices and take necessary corrective and preventive measures.
Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License
These regulations are promulgated pursuant to paragraph 3, article 24 of the Medical Devices Act. Establishing complete GDP ensures that the quality and integrity of medical devices is well maintained throughout the supply chain.
The keynotes of these regulations are listed as the following.
- 1. The issue of the Distribution License.
The distribution license shall be issued upon confirmation of compliance with the Medical Devices Good Distribution Practice Regulations. However, if the applicants failed to fulfill the mentioned inspection, they may apply for a re-assessment within two months after receiving non-compliance notice; this application for re-assessment can only be raised once.
- 2. The management of the Distribution License.
If there are any changes in the name or address of the medical device dealer, these changes should be applied within 30 days from the date of the occurrence.
The Distribution License is valid for 3 years. The extension of the license may be applied within 6 ~ 12 months before the expiry date.
- 3. The inspection of the Distribution License.
An inspection on the operating locations of the medical device dealer may be conducted irregularly without any notification. When conducting an inspection, the inspectors have the right to take any actions in order to secure evidence of any violation found under the Medical Device Act or Medical Devices Good Distribution Practice Regulations.
Medical Device Act