According to the relevant provisions of Article 6 of the Regulations for the Administration of Medical Device Instruction Manuals, Labels, and Packaging Marks (Bureau No. 10), the textual content of overseas medical device manuals, labels, and packaging marks must be in Chinese, and other languages ​​may be added. In accordance with the relevant provisions of Article 48 of the "Measures for the Administration of Registration of Medical Devices" (Bureau No. 16) (hereinafter referred to as the "Measures"), the contents of overseas medical device manuals, labels, and packaging labels should be limited to the content of medical device registration certificates. In line with. Because the production address is also one of the limited contents of the product registration certificate, therefore, many medical device labels, manuals, etc. are not consistent with the limited content of the product's production address and the product registration certificate. This can be done with a medical device without a product registration certificate. Dealt with.
However, the “Notice on Issues Concerning the Labeling and Packaging Labeling of Foreign Medical Devices” (National Food and Drug Administration [2008] No. 634) pointed out that “in the meantime, some local food and drug regulatory authorities have encountered the original label of imported medical device products at work. Inconsistency between the country marked by 'Made in ××(country)' in the packaging label and the country indicated by the 'production site address' in the registration form of the product's medical device registration certificate related to China's relevant management regulations and international trade rules... ... in accordance with the relevant WTO rules, countries of origin of overseas medical device manufacturers marked in some of their imported medical device labels and packaging labels in accordance with international trade rules, such as 'Made in × × (country)' and similar expressions, may be related to Chinese The labeling and packaging markings are inconsistent with the country marked on the 'production site address/production address', which does not violate the relevant provisions of Bureau 16 and Bureau 10 orders." This means that companies can purchase medical devices from outsourced parts. The parts or production addresses of the parts marked may not be the same as the addresses defined in the product registration certificate. However, this is not illegal; only the production address of the whole medical device will take place. Changes only constitute a violation of Article 48 of the Measures. In law enforcement, in order to further confirm that "Made in × × (country)" is the production address of the whole machine or the production address of a certain part or parts, the qualified certificate, packing list, and invoice of the imported medical device can be obtained. And customs clearance and inspection reports.
Determination of the address of commissioning production of machinery and equipment
Article 34 of the "Measures for the Supervision and Administration of Medical Device Production" (Bureau No. 12) stipulates that the entrusted manufacturer's name, company name, and production address of the entrusting party shall be indicated in the brochures, labels, and packaging labels of the commissioned medical devices. Therefore, the production address for the labeling of such medical devices should be the production address of the trustee rather than the production address defined in the entrusted product registration certificate. This does not violate the relevant provisions of the Measures because commissioned production is permitted. It is based on the applicable principles of the “special better than general” law. This applies to the “Medicine Device Production Supervision and Management Measures” instead of “medical devices”. Registration Management Measures.
Jiangsu Rongye Technology Co., Ltd. main products are: disposable medical supplies, medical drainage device, nasogastric tube, general anaesthesia, anesthesia bag, thoracic wear bag, tracheotomy, blood collection tube, etc.