法規收集之範圍：本公司應依據醫療器材產品之銷售地與生產地對醫療器材法規

Scope of the collection of laws and regulations: The company shall collect according to the requirements of medical device laws and regulations in the place of sale and production of the medical device products. The collection is based on the laws and regulations of the place of sale, supplemented by the place of production. In principle, medical equipment can be divided into two parts: pre-marketing and post-marketing regulatory requirements. Before listing, it mainly requires the company's medical device quality management system and product certification safety regulations. After listing, it mainly causes damage to the company's medical equipment. For accidents or serious adverse events, what notifications, announcements, or post-marketing clinical follow-ups should be made.

Scope of collection of regulations: The Company shall collect medical equipment in accordance with the requirements of the regulations on medical equipment in accordance with the place of sale and place of production of medical equipment products. Collection to the sales of local regulations, production as a supplement. Medical equipment in principle can be divided into pre-market and post-market two parts of the regulatory requirements, before the listing is mainly the company's medical equipment quality management system and product certification of the safety requirements, after the listing is mainly the company's medical equipment injury accident or serious adverse events, what should be done to inform, notice issued or post-market clinical tracking.

Scope of regulation collection: the company shall collect the medical equipment according to the requirements of the medical equipment laws and regulations in the place where the medical equipment products are sold and produced. The collection is mainly based on the laws and regulations of the place of sale, supplemented by the place of production. In principle, medical equipment can be divided into pre marketing and post marketing regulatory requirements. Before listing, it mainly requires the quality management system and product certification safety regulations of the company's medical equipment. After listing, it mainly focuses on the company's medical equipment injury accidents or serious adverse events, what kind of notification, notice release or post marketing clinical tracking should be made.