What are the common legal problems of pharmaceutical and medical device enterprises?

I. Legal risks of product quality

l According to Article 4 of the Product Quality Law, producers and sellers bear responsibility for product quality in accordance with the provisions of this law.

l Article 43 Due to defective products causing damage to the person, other people's property, the victim can claim compensation from the producer of the product, but also from the seller of the product. Belonging to the responsibility of the producer of the product, the seller of the product compensation, the seller of the product has the right to recover from the producer of the product. The seller of the product is the responsibility of the seller of the product, the producer of the product compensation, the producer of the product has the right to recover from the seller of the product.

Second, the legal risks of business management

l According to the "Anti-Unfair Competition Law," Article VIII, the operator shall not use property or other means of bribery to sell or purchase goods. Anyone who secretly gives rebates to the other unit or individual off the books shall be punished for bribery; and any other unit or individual who secretly receives rebates off the books shall be punished for bribery.

l Article 22 The operator uses property or other means of bribery to sell or buy goods, constitutes a crime, shall be investigated for criminal responsibility; does not constitute a crime, the supervision and inspection departments may, depending on the circumstances of the case, impose a fine of 10,000 yuan or more than 200,000 yuan or less, and any illegal income, shall be confiscated.

l Bidders shall not collude in bidding, raise the bid price or lower the bid price. Bidders and bidders shall not collude with each other to crowd out fair competition from competitors.

l Article 27 of the bidder collusion bidding, bidding price or low bidding; bidders and bidders collude with each other in order to crowd out competitors in fair competition, its bidding is invalid. Supervision and inspection departments may, depending on the circumstances, impose a fine of 10,000 yuan or more than 200,000 yuan.

l Legal risks of financial issues The medical device industry is characterized by large capital investment and long payback cycles. Medical device business enterprises often on the one hand bear the pressure of the manufacturer's performance, unconditional orders, orders, on the one hand, because of the hospital's management system, can not obtain timely payment. Therefore, the operating enterprise capital pressure is particularly high, and have to ease the capital pressure through loans or financing. Loans or financing one is to increase the operating costs of the enterprise, the second is to increase the risk of legal proceedings.

l Legal Risks in Taxation With the strengthening of the national tax authorities for the high-income industry audit, the medical device industry has also become the key monitoring object of the tax authorities. On the one hand, the state encourages the rapid development of new industries to provide tax incentives, on the one hand, the state for tax avoidance and tax evasion behavior to crack down.

Three, the medical device company legal person risk

The General Principles of Civil Law, Article 49 has the following provisions: The enterprise legal person has one of the following circumstances, in addition to the legal person is responsible for the legal representative can be given administrative sanctions, fines, constitutes a crime, be held criminally liable according to law:

l (a) beyond the registration authorities approved the registration of the scope of business engaged in illegal business;< /p>

l (a) beyond the registration authorities approved the registration of the business engaged in illegal business;< /p>

l (b) beyond the registration authorities approved the registration of the business; < /p>

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l (ii) concealment of the true situation from the registration authority or tax authorities, or falsification;

l (iii) evasion of funds, concealment of property to avoid debts;

l (iv) unauthorized disposal of property after dissolution, revocation, or declaration of bankruptcy;

l (v) failure to timely apply for registration and public announcement of the change or termination of a company, so that the interested party suffers a significant loss;

l (vi) failure to timely apply for registration and public announcement of a change or termination, so that the interested party suffers a significant loss;

l (vii) failure to timely apply for registration and public announcement of a change or termination, so that the interested party suffers a significant loss;

l (vi) Engaging in other activities prohibited by law, to the detriment of national interests or public **** interests of society.

Four, commissioned the production of legal risks

l For the commissioning party, commissioned the production of medical devices does not have the conditions specified in the Regulations, or did not manage the production of the commissioned party's behavior, in accordance with the provisions of the new "Regulations", Article 66 (5) of the provisions of the penalties.

l For the entrusted party, the second class, the third class of medical devices entrusted to the termination of the production, the entrusted party to continue to produce the entrusted products, in accordance with the new "Regulations" Article 63 of the provisions of the penalties.

l For the commissioned parties, the commissioned production is not done for the record, in accordance with the new "Regulations" Article 69, paragraph 1 (d) of the penalty.

V. Comprehensive Legal Risks

l Contract Disputes

l Personnel and Labor Disputes