The MDD received technical data evaluations for pre-market inspection registration requests totaling the following in 2022:
1. Technical evaluation of medical devices clinical trials for 231 case events.
- Evaluation of clinical trials for registration-purpose: 59 case events.
- Evaluation of clinical trials for research-purpose: 172 case events.
2. Registration review for Class II medical device for 412 case events.
3. Evaluation of registration reviews for Class III medical device testing standards: 34 case events.
Technical evaluation of medical devices clinical trials
The MDD received regulatory consultation services for medical device
requests totaling the following in 2022:
(1) Consultation Services
The MDD handled a total of 221 consultation case events. Among which, consultations related to regulatory validation of medical devices: 115 case events, general regulatory consultations: 53 case events, clinical trial design consultations: 37 case events, and others: 16 case events.
(2) Guidance for Index Cases
The MDD provided guidance for 34 index case events in medical devices: Pre-clinical stage: 27 case events, clinical trial stage: 4 case events, and registration and market approval stage (including post-market): 3 case events.
(3) Medical Device Consultation Hotline
In 2022, the MDD received a total of 30,964 inquiries through its consultation hotline. The majority of inquiries were related to medical device registration, totaling 10,537 case events, and others were 20,427 cases events.
Consultation Services
Guidance for Index Cases
Medical Device Consultation Hotline
Since 2011, the MDD has been actively involved in assisting government subsidized cases from the Ministry of Science and Technology and the Ministry of Economic Affairs/National Science and Technology Council, through the provision of regulatory assessments and recommendations.
These recommendations serve as references during project subsidy selection and evaluation of project progress.
Additionally, this assistance helps project leaders advance innovative research outcomes from basic research to commercialization, extend scientific research results to clinical trials, and even support successful market launches. In 2022 alone, 164 regulatory assessments and progress evaluations for medical device subsidy projects were completed.
To keep pace with advancements in regulatory science and align with international standards, the division continuously develops criteria and regulations that meet risk management and industry needs for new medical device products. Moreover, it establishes standard operating procedures and review focus areas necessary for regulatory review, providing guidelines for health authorities and industry stakeholders to follow.
In 2022, the division contributed to the deliberation of three regulatory projects by the central health authority, detailed as follows:
1. Drafting of “Pre-clinical Testing Guidance for Tissue Adhesives with Adjunct Wound Closure Device for on Topical Approximation of Skin.”
2. Drafting of “Guidance for Pre-clinical Testing of Intraocular Lens.”
3. Drafting of “Guidance for Pre-clinical Testing of Contact Lens Care Products for Soft and Rigid Gas Permeable Contact lens”
