Applicable medical devices need remediation

On March 18, the former State Food and Drug Administration issued the Notice on Launching a Special Inspection for the Registration of Applicable Medical Devices (hereinafter referred to as the “Notice”), and arranged to carry out special inspections on the registration of medical devices that adhere to the country. The main problems currently existing in medical devices for patching are the non-standard production of approvals, the large number of counterfeit products, and the involvement of illegal advertisements. This special inspection is just a beginning. Follow-up inspections should be conducted on the entire range of applicator medical devices from approval to production, from sales to advertising.

Non-standard examination and approval of all types of applicator medical devices mostly belong to Class I and Class II medical devices. The appraisal rights for Class II medical devices are at the provincial CFDA, and the approval authority for Class I medical devices is at the municipal CFDA. Due to the large number of drug regulatory authorities that have the power of approval, the relevant examiners have different degrees of understanding of laws, regulations, and policies, resulting in irregularities in the approval process of such medical devices. There are mainly the following situations:

1. Approve drugs as medical devices. The former State Food and Drug Administration stated clearly in the "Notice Concerning the Registration of Pharmaceutical and Commodity Products" that "For the combination of pharmaceutical and medical products based on the role of drugs, registration of drugs must be applied; for combination of medical and medical products based on the role of medical devices, it is necessary to declare Registration of medical devices.” At the same time it was clearly stated that “the stents with drug coatings, catheters with antibacterial coatings, drug-containing condoms, drug-containing birth control rings, etc., are registered and managed according to medical devices, and contain wounds containing antibacterial and anti-inflammatory drugs. , Chinese medicine external application products, such as registration management of drugs. "But there are still many on the market with antibacterial, anti-inflammatory drugs wound paste, Chinese medicine external application of products according to a class of medical devices for approval.

2. Extensive application of approved products. The scope of application of the product should undergo a rigorous scientific verification, and content can not be arbitrarily increased or decreased. However, at present, the scope of application of many types of medical devices is too large, and it is almost a cure for all diseases. There are also cases in which the scope of application of the product is exaggerated in a disguised way, that is, the same product is subdivided into different specifications and models, with different scopes of application.

3. High class low batch. The purpose of classifying three types of medical devices as Class 2 medical device approvals or Class 2 medical devices as a class of medical devices is to reduce the level of examination and approval authorities, thereby making it easier to obtain product registration certificates.

4. Approve non-devices as devices. The State stipulates that, for sticking products containing only chemical constituents, Chinese herbal medicines (or natural plants) and their extracts, whether or not the constituents are included in the Pharmacopoeia, they must explain and verify the intended purpose and role of adding such ingredients. mechanism. If the contained ingredients exert pharmacological, immunological or metabolic effects, they should not be registered as medical devices. However, in many places, the approval of such products as medical devices also appears to have increased the level of product management on the surface. However, it is actually to facilitate the labeling of treatment content for diseases, and it is easy to mislead consumers.

Illegal Products Many see-through medical devices that circulate on the market, misappropriating existing medical device product registration numbers, or making fake medical device product registration numbers out of thin air are not uncommon. Most of these products come from underground factories. The sales methods are: Clerk home spot cash transaction.

Most of the attached medical devices are Class I and Class II medical devices, and the management requirements are not particularly strict. In particular, according to the type of medical devices covered by a type of medical device, the safety awareness of manufacturers of such products is not strong, the production conditions are poor, and the purchase of raw materials is not strictly controlled, even shoddy, and even worse. Add drugs or other ingredients without authorization in the product.

In order to facilitate sales, many applicator medical device product labels do not meet the restrictions of the registration certificate. The most common is the scope of application of products, specifications, models, names, etc. do not meet the product registration certificate limits. Some expand the scope of application of the product and cure all diseases; some use a product registration certificate with different specifications and models, resulting in more than a dozen varieties of products; some eye-catching logo "United States × × producer", "Hong Kong × × "Producer" and other words, but the real manufacturer's name is marked with a very small font in an inconspicuous position.

It is necessary to thoroughly clean up the “Notice” to require the review of previously approved products, and to clean up the applicator medical device products that have been approved for violation of laws and regulations, so as to further standardize the registration approval criteria for relevant products and effectively resolve non-medical devices according to medical treatment. Device approval and high-grade and low-level issues.

However, examining only the approval process does not solve all the problems of such products. The author believes that it is necessary to carry out special inspections of applicator medical devices from approval to production, from sales to advertising.

First of all, strict approval procedures do not allow illegal approval. Approval is the source and strict examination and approval is the original source of medical equipment. In the process of approval, product attributes should be clearly distinguished to determine whether the product is a medical device or other product. The combination of drug and medical products should be based on the role of drugs or medical devices. In addition, we must distinguish the product categories of medical devices, and strictly control the scope of application of medical devices, and prohibit the arbitrarily expanding the scope of products.

Second, strictly control the purchase procedures and prevent illegal products from entering the store. Although a type of medical device does not require a Medical Device Operation Enterprise License, a type of medical device also requires registration. Therefore, the audit of a type of medical device purchased includes review of the Product Registration Certificate and Business License. And purchase bills, and carefully examine the physical objects to see if it strictly meet the product registration certificate. For the purchase of Class II medical devices, in addition to the content of Class I medical devices that need to be reviewed, the counterparty's “Medical Device Operation Enterprise License” must be reviewed. Products that have no product registration certificate and any products that exaggerate the scope of application are rejected outside the door.

Once again, strict supervision will not allow illegal activities. We will intensify the inspection of such medical devices, organize timely special rectifications, and once we discover violations of the law, we will firmly deal with the principle of “five not missed”. Tracing the origins, appropriate joint public security, health and other departments to carry out inspections, and resolutely crack down on underground factories, severely deal with operating companies and individuals operating illegal products. We will maintain a high pressure on the supervision of such medical devices, increase the monitoring of advertisements for illegally posted medical devices, and promptly transfer them to the business sector.