Declaration Of Medical Device Contract Template

Declaration of medical device contract template

Contract number: Beijing code Y_______

Party A: Party A: the company is a Company Limited (hereinafter referred to as Party A).

Party B: Beijing Pharmaceutical Co., Ltd. (hereinafter referred to as Party B)

After consultation with both parties, the following contract is reached for the declaration of medical devices related to products.

One, the two sides agreed

1. Party A agrees to submit the declaration work of the products to Beijing.

2. in the process of declaration, the two sides consult with each other and assist each other.

3. Party B shall keep confidential for Party A, and shall not disclose the product information provided by Party A.

4. during the reporting period, if the policy fee is adjusted according to the policy adjustment, such as the experimental fee, the appraisal fee, the declaration process and the requirement, the two sides will not be held responsible for the implementation of the new policy.

Two, mutual responsibility

1. Party A shall provide Party B with relevant information about the declared products, {the qualification certificate of the medical device manufacturer, the product technical report, the safety risk analysis report, the product performance self-test report, the product user manual, and the certification document of the production and sale of the product in the production country (region).

2. Party A shall provide Party B with necessary information for inspection (product manuals, declaration of enterprise related information and sample for inspection), and Party B can arrange for inspection.

3. Party A will provide agent fees to Party B for RMB, yuan, TK, TK, TK, TK $10000.

4. Party B is responsible for all declarations of product declaration, data collation, related consultation, etc.

5. from the effective date of the contract to the completion of the declaration before the completion of the contract, and report to the drug administration.

6. after the acceptance of the drug administration, the medical device approval certificate will be obtained within the month.

7. if the product itself is found to be in question during the experimental period,

Three. Mode of payment

1. within 3 days from the effective date of the contract, Party A will pay the agent fee to Party B for the total amount of RMB yuan, TK, TK, TK, TK $10000.

2. within 3 days after obtaining the notice of acceptance by the drug administration, Party A will remit the fee to the designated account.

At the same time, we will pay agent fees to Party B for a total of RMB yuan, yuan, yuan, yuan, and ten thousand yuan.

3. within 3 days after obtaining the medical device approval certificate issued by the drug administration, Party A will pay the agency fee to Party B for a total of RMB yuan, min, TK, TK, TK, TK $10000.

4. Party B shall notify Party A in written form, Party A shall pay the laboratory fee directly to the testing institution within 3 days after obtaining the notice, and Party B shall obtain the invoice from the relevant authorities and provide it to Party A.

5. Party B will issue the corresponding receipts after the receipt of the agency fee.

Four. Default and others

1. Party B will return the payment to Party A if Party B fails to terminate the experiment or fail to declare.

2. Party B shall pay Party A 100 thousand yuan RMB for breach of confidentiality due to Party B's reasons.

3. if Party A delays payment of the sum stipulated in this contract, it will pay to Party B by default of three thousand per cent (3 per cent) per day. If Party B has the right to terminate the contract more than 30 days, party a must make up the experimental fee and agency fee within 3 days.

4. if Party A postponed payment of the cost of the product's experimental fees and appraisal fees and so on, the product declaration cycle will be postponed according to the delay to the payment period, and Party B will not pay any liability.

5. if the declaration is delayed due to the reason of Party B, the penalty shall be paid to Party A at a rate of three thousand (3 per thousand) per day. If more than 30 days, Party A will have the right to terminate the contract, and ask Party B to refund the expenses paid by Party a.

6. because of the change of policy or the reasons for non resistance, the declaration is blocked or the declaration fails. Neither Party A or B assumes responsibility, and it should be negotiated according to the specific circumstances.

Five. There are two copies of this contract. Each party holds one copy.