In daily life and work, the use of the letter of commitment is more and more places, the letter of commitment is composed of six parts: the title, the opening sentence, the body, the conclusion, the signature, the date. So the question comes, in the end, how should write a proper letter of commitment? Here is my medical device business enterprise commitment letter, welcome to learn and reference, I hope to help you.
Medical device business enterprise commitment 1In order to strengthen the supervision and management of the hospital medical device business enterprise, standardize the business order of the medical device market, to ensure that the medical device products are safe, effective, and better fulfill the self-supervision of the medical device business, according to the "Medical Device Supervision and Administration Regulations" and "supervision and management of the medical device business enterprise approach" and other relevant provisions, the enterprise voluntarily with the Jingning County People's Hospital signed a letter of commitment to abide by the integrity of the law, to ensure the quality of the products sold, the commitment is as follows:
1, study the relevant national laws and regulations, consciously comply with the relevant provisions of the sale of medical equipment business, to ensure that the business sales in accordance with the law.
2, to strengthen the management of medical device product quality, establish and improve the quality assurance system, adhere to the "quality first" policy.
3, adhere to the implementation of the medical device product warehousing system, to eliminate the sale of medical devices without warehousing acceptance of the product.
4, the procurement of medical equipment, strict implementation of the "first enterprise (varieties) audit system", the unlicensed, incomplete license products or products of unclear origin, not purchased.
5, on the procurement of products, to ensure that the acceptance rate of 100% of the warehouse, the acceptance of unqualified products will not be warehoused.
6, the custody of the products in the warehouse, in strict accordance with the classification, zoning, batch management, adhere to the "first in, first out" principle. Do a good job of warehouse storage account, do a good job of warehouse "five prevention" work.
7, strict sales of medical equipment, to prevent the sale of medical equipment to non-qualified, non-qualified units or individuals.
8, the establishment of medical device product quality traceability system. For high-risk medical device products to establish an adverse event reporting system and recall system.
9, strict quality control of medical device products, to prevent counterfeit and shoddy medical devices
device products into the market.
10, the quality of the administrator and acceptance of changes in the local food and drug supervision and management department for the record in a timely manner.
11, in accordance with the medical device specification labeling content of the introduction, not exaggerated propaganda, not over the scope of publicity.
The above is the enterprise's self-commitment, welcome the relevant government administrative supervision and management departments and the news media on our administrative supervision and public opinion supervision, if there is a violation of the above commitments, the enterprise is willing to accept the food and drug supervision and management departments of the treatment.
Enterprise legal representative (or) person in charge (signature):
Enterprise official seal:
Monthly
Director in charge:
() Food and Drug Administration (Chapter):
Monthly
Medical Device Business Enterprise Commitment 2In order to conscientiously carry out the implementation of the "Supervision and Administration of Medical Devices Regulations" and the "Supervision and Administration of Medical Device Business Enterprises" and the "Medical Device Management Measures".
2, from the law to obtain valid qualifications of medical equipment manufacturers or business enterprises to purchase qualified medical equipment, take the initiative to the supplier to obtain and retain the official seal stamped with a copy of the valid qualifications.
3, the purchase of medical equipment to check the product certification, no license, incomplete license, no sales invoices of products or products of unclear origin, not purchased.
4, the purchase of medical equipment to take the initiative to obtain and retain valid bills, the establishment of a sound purchase, acceptance records.
5, on the library of the product `storage, in strict accordance with the classification, partition, batch management, adhere to the "first in first out" principle.
6, the business premises display medical devices to implement classification management, according to a class, class II, class III classification, classification mark placement should be accurate, eye-catching.
7, to ensure that the sale of unregistered, no proof of conformity, expired, invalid or obsolete medical devices. Sales of Class II and Class III medical devices to establish a sound sales record of medical devices to ensure the traceability of medical devices.
8, seriously in accordance with the statutory conditions and requirements for medical equipment business activities, shall not remove or change the warehouse without authorization, shall not change the business address, business area.
9, the enterprise quality person in charge should be on duty. Staff in direct contact with medical devices, as required by an annual health checkup.
10, to strengthen staff training, the establishment of a sound business continuing education file.
11, not illegal to publish medical device advertising, actively and conscientiously do a good job of monitoring adverse events of medical devices.
Commitment unit: xxx Responsible person: xxx (enterprise official seal)
xxxx year xx month xx
Medical device business enterprise commitment 3To strengthen the supervision and management of the city's medical device business enterprises, standardize the business order of the market of medical devices, to ensure the safety of medical equipment products, effective, and better fulfill the self-supervision of the medical device business 2, our company promises never to produce, sell counterfeit drugs and production, sale of inferior drugs, if the violation of the provisions of the company responsible for the competent personnel and other directly responsible personnel within ten years shall not engage in the production of drugs, business activities. The raw and auxiliary materials, packaging materials, and production equipment used in the production of counterfeit and substandard drugs will be confiscated.
3. Our company promises that if we violate the provisions of this law, provide false certificates, document information samples or take other deceptive means to obtain the "Drug Manufacturing License", "Drug Business License", "Medical Institutions Preparation License" or the drug approval documents, voluntarily revocation of the "Drug Manufacturing License", "Drug Business License", "Medical Institutions Preparation License" or withdrawal of the Drug approval certification documents, no further application within five years, and impose the required payment of 10,000 yuan or more than 30,000 yuan fine.
Enterprise legal representative (or) person in charge (signature):
Quality person (signature):
Quality officer (signature):
Acceptance officer (signature):
Enterprise official seal:
Month and year