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Medical device production address, which do you know?

Medical device production address, which do you know?

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[Abstract]:
InaccordancewiththerelevantprovisionsofArticle6oftheRegulationsontheHandlingofMedicalDeviceManuals,LabelsandPackagingLabels(OrderNo.10),thecontentsoftheinstructions,labelsandpackagingmarksforoverseasm
In accordance with the relevant provisions of Article 6 of the Regulations on the Handling of Medical Device Manuals, Labels and Packaging Labels (Order No. 10), the contents of the instructions, labels and packaging marks for overseas medical devices must be in Chinese, and other languages ​​may be attached. In accordance with the relevant provisions of Article 48 of the Measures for the Administration of Registration of Medical Devices (Decree No. 16) (hereinafter referred to as the “Measures”), the contents of overseas medical device instructions, labels and packaging labels shall be in accordance with the contents of the medical device registration certificate. Compatible. Since the production address is also one of the limited contents of the product registration certificate, many of the medical device labels, instructions and other signs indicate that the production address is inconsistent with the limited content of the product registration certificate, and can be carried out according to the medical device without the product registration certificate. Processed.
However, the "Notice on Issues Concerning Labels and Packaging Labels for Overseas Medical Devices" (Guo Food and Drug Administration [2008] No. 634) pointed out that "in recent days, some local food and drug regulatory authorities have encountered the original label of imported medical device products at work. And the country marked with 'Made in ××(country)' in the packaging label is inconsistent with the country indicated in the 'Production Location Address' in the medical device registration certificate registration form of the product. It involves China's relevant management regulations and international trade rules... ...in accordance with the relevant rules of the WTO, overseas medical device manufacturers in accordance with international trade rules, in the country of origin of some of the imported medical device labels and packaging labels, such as 'Made in × × (national)' and other similar expressions, may be in Chinese The country marked in the 'Production Location/Production Address' in the label and the packaging label is inconsistent. This situation does not violate the relevant provisions of the 16th Order and the 10th Order of the Bureau." This means that companies can purchase medical devices out of parts, and the country of manufacture or production address marked with the parts is likely to be inconsistent with the address defined by the product registration certificate, but this situation is not illegal; only the production address of the medical device is generated. The change constitutes a violation of the provisions of Article 48 of the Measures. In the law enforcement, in order to further confirm that "Made in × × (country)" is the production address of the whole machine or the production address of one or some parts, the certificate of conformity, packing list and invoice of the imported medical device can be obtained. And customs clearance and commodity inspection reports.
Authorization of the production address of medical equipment
Article 34 of the Measures for the Supervision and Administration of the Production of Medical Devices (Decree No. 12) stipulates that the medical instruments entrusted to be produced shall bear the name of the enterprise of the entrusting party, the name of the enterprise of the entrusted party and the production address. Therefore, the production address indicated for such medical devices shall be the address of the trustee's production, not the production address as defined in the client's product registration certificate. This does not violate the relevant provisions of the Measures, because entrusted production is allowed, based on the applicable principle of the “specially superior to the general” law, this case applies to the “Measures for the Supervision and Administration of Medical Device Production” rather than “Medical Devices”. Registration Management Measures.
The main products of Jiangsu Rongye Technology Co., Ltd. are: disposable medical supplies, medical drainage devices, nasogastric tubes, general anesthesia bags, anesthesia bags, chest piercing bags, tracheotomy, blood collection tubes, etc.