Hainan Medical Device Registration Consulting Company Shares Some Basic Knowledge about Medical Devices

Do you know any basic knowledge about medical devices? If not, quickly check out this article shared by Hainan Medical Device Registration Consulting Company!

1. How to distinguish between drugs and medical devices containing drug components?

(1) For products where the drug plays a major role and the medical device plays an auxiliary role (such as syringes pre-filled with drugs), they are managed as drugs.

(2) For products where the medical device plays a major role and the drug plays an auxiliary role (such as drug-eluting stents, catheters with antibacterial coatings, drug-eluting condoms, drug-eluting IUDs, etc.), they are managed as medical devices.

(3) Wound dressings containing antibacterial and anti-inflammatory drugs are managed as drugs.

(4) Traditional Chinese medicine external application products, as traditional Chinese medicine external application agents, are managed as drugs.

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2. What qualifications are required to operate a medical device business?

To establish a Class I medical device business, registration must be made with the drug regulatory authority of the provincial, autonomous region, or municipal government. To establish a Class II or Class III medical device business, approval must be obtained from the drug regulatory authority of the provincial, autonomous region, or municipal government, which will issue a "Medical Device Business License." Without a "Medical Device Business License," the industry and commerce administration department shall not issue a business license.

3. Do medical devices need to undergo clinical trials before being marketed?

Clinical trials for medical devices are divided into clinical trials and clinical validation.

For medical devices that have not yet appeared on the market and whose safety and effectiveness need to be confirmed, clinical trials are required before market approval.

For medical devices that are already on the market but whose safety and effectiveness require further confirmation, clinical validation is required before market approval.

4. What kind of management system does my country implement for the production of medical devices?

my country implements a product registration system for medical devices.

(1) Production of Class I medical devices requires review and approval by the municipal-level drug regulatory authority, which will issue a product registration certificate.

(2) Production of Class II medical devices requires review and approval by the provincial-level drug regulatory authority, which will issue a product registration certificate.

(3) Production of Class III medical devices requires review and approval by the State Council's drug regulatory authority, which will issue a product registration certificate.

5. What six certificates should be checked when purchasing medical device products?

(1) Product Certificate of Conformity.

(2) Medical Device Manufacturing Enterprise License (for Class II and III medical device manufacturers).

(3) Medical Device Business Enterprise License (for businesses dealing in Class II and III products other than the thirteen Class II products).

(4) Medical Device Product Registration Certificate.

(5) 3C Certification Certificate (Medical devices listed in the "Catalogue of Products Subject to Compulsory Product Certification" should have a 3C certification certificate and mark).

(6) EMC Certificate (for medical electrical equipment).

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Hainan Nayang Biomedical ★★★ is a professional Hainan medical device consulting service company and service provider. Its main businesses include: Hainan medical device consulting services, Hainan medical device registrant MAH services, Hainan medical device digital therapy CRO consulting services, digital therapy CDMO, commissioned R&D and production CDMO, and clinical trial CRO consulting services. It owns active and passive plant facilities and laboratories, serving clients in active equipment products, polymer material products, and IVD products.