Commitment letter of medical device management enterprise

In daily life and work, more and more places use commitment letters. The letter of commitment consists of six parts: title, opening remarks, text, conclusion, signature and date. Then the question is coming, how should we write a proper commitment letter? The following is the commitment letter of medical device business enterprise that I compiled for you. Welcome to draw lessons from and refer to. I hope it helps you.

Commitment letter of medical device business enterprise 1 In order to strengthen the supervision and management of hospital medical device business enterprise, standardize the management order of medical device market, ensure the safety and effectiveness of medical device products, and better fulfill the self-regulatory responsibility of medical device business, according to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Business Enterprises, the enterprise voluntarily signed a commitment letter with Jingning County People's Hospital, promising to be honest and trustworthy, operate according to law, and ensure the quality of products sold.

1. Seriously study the relevant national laws and regulations, and consciously abide by the relevant regulations on the operation and sales of medical devices to ensure the operation and sales according to law.

2 strengthen the quality management of medical device products, establish and improve the quality assurance system of this enterprise, and adhere to the enterprise policy of "quality first".

3, adhere to the implementation of medical device product warehousing system, put an end to the sale of medical device products without warehousing acceptance.

4. The procurement of medical devices shall strictly implement the "first-run enterprise (variety) audit system", and products without licenses or incomplete licenses or products with unknown sources shall not be purchased.

5. For purchased products, the qualified rate of warehousing shall be 100%, and unqualified products shall not be warehousing.

6. The products in the warehouse should be kept in strict accordance with the classification, zoning and batch management, and adhere to the principle of "first in, first out". Do a good job of keeping the warehouse account and do a good job of "five precautions" in the warehouse.

7. Strictly control the sales of medical devices, and put an end to selling medical device products to units or individuals without business qualifications and use qualifications.

8, the establishment of medical device product quality traceability system. Establish an adverse event reporting system and a recall system for high-risk medical device products.

9. Strictly control the quality of medical devices and prevent fake and inferior medical devices.

Mechanical products flow into the market.

10, when the quality manager and inspector change, report to the local food and drug supervision and management department for the record.

1 1. Introduce according to the contents marked in the medical device instructions, and do not exaggerate publicity or use beyond the scope.

The above is the self-commitment of the enterprise. We welcome the relevant administrative supervision departments of the government and the news media to carry out administrative supervision and public opinion supervision on us. If there is any violation of the above commitments, the enterprise is willing to accept the handling of the food and drug supervision and management department.

Legal representative (or) person in charge of the enterprise (signature):

Official seal of enterprise:

Date, month and year

Director in charge:

() US Food and Drug Administration (Seal):

Date, month and year

Commitment Letter of Medical Device Business Enterprise 2 In order to conscientiously implement the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Business Enterprises and other relevant laws and regulations, strengthen the awareness that enterprises are the first responsible person for the quality of medical devices, better perform the self-discipline duties of medical device business enterprises, standardize the market operation order of medical devices, and ensure the people to use safe and effective medical devices, we hereby solemnly promise as follows:

1. Seriously study the relevant national laws and regulations, consciously abide by the relevant provisions of medical device management, ensure legal operation, and be willing to bear all legal responsibilities caused by illegal operation.

2. Purchase qualified medical devices from medical device manufacturers or business enterprises that have obtained valid qualifications according to law, and take the initiative to ask for and keep copies of valid qualifications stamped with the official seal from suppliers.

3. When purchasing medical devices, verify the product qualification certificate, and don't buy products without licenses, incomplete licenses or unclear sales bills.

4. When purchasing medical devices, take the initiative to ask for and keep valid bills, and establish and improve the purchase and acceptance records.

5. The products in the warehouse should be kept in strict accordance with the classification, zoning and batch management, and adhere to the principle of "first in, first out".

6. The medical devices displayed in the business premises shall be placed according to the first, second and third categories, and the classification marks shall be accurate and eye-catching.

7. Ensure that unregistered, unqualified, expired, invalid or obsolete medical devices are not sold. When selling the second and third types of medical devices, it is necessary to establish and improve the sales records of medical devices to ensure the traceability of medical devices.

8. Seriously engage in medical device business activities in accordance with legal conditions and requirements, and shall not dismantle or change the warehouse without authorization, and shall not arbitrarily change the business address and business area.

9. The person in charge of enterprise quality should be on the job. Staff who are in direct contact with medical devices shall have a physical examination once a year in accordance with the regulations.

10, strengthen employee training, establish and improve enterprise continuing education files.

1 1. Do not illegally publish medical device advertisements, and actively and conscientiously monitor medical device adverse events.

Commitment unit: xxx Responsible person: xxx (official seal of the enterprise)

Xxxx、xxxx、xx、xx

Commitment Letter of Medical Device Operation Enterprise 3 In order to strengthen the supervision and management of medical device operation enterprises in our city, standardize the operation order of medical device market, ensure the safety and effectiveness of medical device products, and better perform the self-regulatory duties of medical device operation, according to the Regulations on the Supervision and Administration of Medical Devices, the Drug Administration Law and other relevant provisions, the enterprise voluntarily promises to the food and drug supervision and management department as follows:

1. Our company promises not to operate or use medical devices that are not registered according to law, have no certificates, and are expired, invalid or obsolete. Our company promises never to produce or sell fake or inferior drugs. In violation of the provisions, the person in charge of the company and other directly responsible personnel shall not engage in pharmaceutical production and business activities within ten years. And confiscated raw and auxiliary materials, packaging materials and production equipment used to produce counterfeit and inferior drugs.

3. Our company promises that, in violation of the provisions of this Law, it will voluntarily revoke the Pharmaceutical Production License, Pharmaceutical Trading License, Pharmaceutical Trading License or Pharmaceutical Approval Document if it provides false certificates or sample documents or obtains the Pharmaceutical Production License, Pharmaceutical Trading License, Pharmaceutical Trading License or Pharmaceutical Approval Document by other deceptive means, and will not apply again within five years, and pay the fee as required/kloc.

Legal representative (or) person in charge of the enterprise (signature):

Quality Director (signature):

Quality controller (signature):

Inspector (signature):

Official seal of enterprise:

Date, month and year