I. Catalog of Class III Medical Devices Requiring Clinical Trial Approval:
1. Implantable Cardiac Rhythm Management Devices
Implantable Cardiac Pacemakers: Usually consists of an implantable pulse generator and a torque wrench. An electrical pulse is applied to a specific part of the patient's heart through a pacing electrode. Used to treat chronic heart rate disorders. Resynchronization therapy pacemakers are also used for heart failure treatment.
Implantable cardiac defibrillator: usually consists of an implantable pulse generator and a torque wrench. Corrects ventricular tachycardia and fibrillation by detecting them and applying cardioverter/defibrillator pulses to the heart through electrodes. Used to treat fast ventricular arrhythmias. Resynchronized therapy defibrillators are also used for heart failure treatment.
2. Implantable ventricular assist system
Usually consists of an implantable pump body, a power supply section, vascular connections, and a controller. Used to provide mechanical support for the circulation of patients with progressive refractory left heart failure, for transitional and/or long-term treatment prior to heart transplantation or restoration of cardiac function. It is intended for use in healthcare facilities that are equipped to provide comprehensive postoperative care for heart transplantation, with appropriate training for medical staff, out-of-hospital caregivers, and patients. Contraindicated in patients intolerant to anticoagulation therapy.
3. Implantable drug delivery devices
Usually consist of a drug infusion pump, a reperfusion component, and a catheter entry component. The product is used in conjunction with an intrathecal catheter for long-term drug input.
4, artificial heart valves and endovascular stents
Prosthetic heart valves or valve repair devices: generally made of polymers, animal tissues, metal materials, inorganic non-metallic materials, with or without surface-modifying substances. Used to replace or repair natural heart valves.
Endovascular stents: stents are generally made of metal (including absorbable metal materials) or polymer materials (including absorbable polymer materials), and their structure is generally in the form of a mesh frame. Stents may or may not contain surface-modifying substances, such as coatings. It may contain pharmaceutical ingredients. For example, it is used for the treatment of atherosclerosis, and various stenotic, obstructive or occlusive and other vascular lesions.
5, containing living cells of the tissue engineering medical products
To medical devices, mainly containing living cells of passive implantable tissue engineering medical products.
6, absorbable limb long bone internal fixation implantation device
Absorbable polymer materials or absorbable metal materials made of, applicable to limb long bone fracture internal fixation.
Second, the application process
1, acceptance
The use of medical device registration electronic filing information system, without written paper materials to the State Drug Administration Medical Device Technical Review Center for submission by the State Drug Administration of Medical Devices Technology Review Center to check whether the acceptance.
2, technical review
When the State Drug Administration Medical Device Technical Review Center acceptance, the approval of the project will be technical review and put forward the corresponding technical review. There will be a review of the review comments and the issuance of review reports.
3, administrative approval
Wait until the end of the technical review process, there will be administrative approval of such a process, mainly on the territory of the third and imported Class II, Class III medical device product registration, change of registration, continuation of registration, clinical trial approval of the acceptance of the technical review of the review content and review the process of administrative review, and based on the conclusions of the technical review of the registration approved or not administrative license decision. Or not administrative licensing decisions.
Legal basis
Methods for the Administration of Registration and Filing of Medical Devices, Article 45 The clinical trial of medical devices shall be implemented within three years after approval; the application for the clinical trial of medical devices from the date of approval, within three years, without the signing of informed consent by the subjects, the clinical trial of the medical device license shall expire on its own. Still need to conduct clinical trials, should re-apply.
"Supervision and Administration of Medical Devices Regulations"
Article 18 The acceptance of the application for registration of drug supervision and management shall be received within 20 working days from the date of review to make a decision. To meet the conditions, granted registration and issue a medical device registration certificate; do not meet the conditions, not registered and a written explanation of the reasons.
Accepting the application for registration of drug supervision and management department shall, within five working days from the date of registration of medical devices, through the State Council drug supervision and management department of the online government service platform to the community to publish the registration of relevant information.
Article 22 The registration of medical devices is valid for five years. The expiration of the validity of the need to renew the registration, should be valid six months before the expiration of the original registration department to apply for renewal of registration.
Except for the third paragraph of this article, the continuation of the application for registration of drug supervision and management departments should be in the medical device registration certificate before the expiration of the decision to grant the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
One of the following circumstances, the continuation of registration shall not be:
(a) not within the prescribed period of time to apply for renewal of registration;
(b) the mandatory standards for medical devices have been revised, apply for renewal of registration of medical devices can not meet the new requirements
(c) the approval of the conditions attached to the medical device, medical devices are not completed within the prescribed period of time, the certificate of registration of the medical device. Matters.