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In August 2026, a "Guideline on the Whole Chain Investigation and Handling of Commercial Bribery and Related Crime Cases in the Field of Pharmaceutical Purchase and Sales" was circulated in the industry.This report is said to be a case guide developed by the five police types of investigation, technical investigation, food and drug ring investigation, network security, and legal system. It establishes "full chain penetration, four-flow integration, data guidance and investigation, execution connection, and closed-loop strike" as the core of case handling. Applicable objects include medical circulation, investment promotion agents, two-vote distribution, CSO academic outsourcing, high-consumption general representatives, hospital-side pure sales, hospital-side channels, grass-roots transfers, Internet hospitals, patient assistance projects, and medical representative filing systems.
Although the Guidelines are currently available online, many of the legal rules referenced in the Guidelines have been formally implemented.For companies in the "cosmetics combined" circuit, these regulations are not only reshaping the compliance ecology in the field of medicine and medical devices, but their conduction effects are also changing the industry rules for cosmetics and medical devices.
I. Regulatory Context: Accelerating the Improvement of the System
Criminal Law Amendment (XII): Bribery in the medical field is statutory
On March 1, 2024, the Criminal Law Amendment (XII) Act came into force.According to the announcement of the Standing Committee of the National People's Congress, the amendment clearly listed "bribery in the medical field" as a statutory severe punishment, and established the tone of severe punishment for bribery in the medical field from the level of criminal legislation.
Legal Interpretation [2026] No. 6: Criminalization Criteria and Unit Penetration
On April 10, 2026, the Supreme People's Court and the Supreme People's Procuratorate issued "Interpretation (II) on Several Issues Concerning the Application of Law in Handling Criminal Cases of Corruption and Bribery" (Legal Interpretation (2026) No. 6), which came into effect on May 1, 2026.According to the official website of the National Health Insurance Administration (nhsa.gov.cn) the information published, the judicial interpretation is clear:
- The unit bribes more than 200,000 yuan and is deemed to be "serious", and more than 2 million yuan is deemed to be "especially serious";
- Bribery in the fields of food, medicine, medical treatment, etc. is a statutory aggravating circumstance;
- The sentencing standards for the crimes of bribery of non-State personnel and bribery of non-State personnel are implemented with reference to the crimes of bribery and bribery;
- If the unit collectively decides or the actual controller or supervisor decides that the illegal income belongs to the unit, the unit shall be convicted and punished for the crime of bribery, and the cutting path of "individual employee behavior" shall be blocked;
- Refine the rules for determining the amount of expected return bribes such as equity and options.
According to the official website of the Supreme People's Court, the interpretation leveled the sentencing standard for the crime of bribery of non-state personnel with that of state personnel, which means that sales personnel and procurement personnel in pharmaceutical companies and medical device companies take advantage of their positions to receive rebates, and the sentencing standard has been significantly improved.
Five Sectors Integrity Governance Regulations and 14 Sectors Wind Rectification Key Points
On May 1, 2026, the "Several Provisions on Integrity Governance in the Field of Pharmaceutical Purchase and Sales" jointly issued by the National Supervision Commission of the Central Commission for Discipline Inspection, the National Health and Health Commission, the National Medical Insurance Administration, the National Drug Administration, and the State Administration of Market Supervision was formally implemented.According to the website of the National Supervision Commission of the Central Commission for Discipline Inspection, this regulation covers the entire chain of production, circulation and use of pharmaceuticals, and is a landmark document for the joint and systematic promotion of integrity governance in multiple departments.
On June 8, 2026, the National Health Commission and 14 other departments jointly issued the "Key Points for Correcting Unfair Work in the Field of Pharmaceutical Purchase and Sales and Medical Services in 2026".According to the public information on the official website of the National Health and Health Commission, the key points are to rectify the "key minority" illegal intervention of the purchaser, the splitting of the project to avoid public bidding, customized bidding, "clear bidding" and other behaviors; crack down on the borrowing of licenses, false transactions, and commercial bribery of the bidder; for the first time, "rectify tax-related illegal acts" will be listed separately; strengthen the supervision of the whole process of medical data.
At the level of industry supervision, according to the National Medical Insurance Administration's "Medical Price and Adoption Credit Evaluation System", if the amount of bribes reaches 10,000 yuan, it can be included in the list of dishonesty, facing penalties such as cancellation of hanging nets and collecting qualifications.In terms of the reverse investigation mechanism, the violation was reversed for 5 years, and the major losses involving the medical insurance fund can be traced back 20 years. Retirement, resignation, and transfer are not exempt from liability.
II. In-depth Interpretation of Case Handling Mode: Five Types of Police Collaboration and Data Detection
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The upgrading of the investigation mode reflected in the online communication and case handling guidelines has important signal significance for medical devices and cosmetics joint ventures.
Professional coverage of the five types of police cooperation
After the investigation is responsible for the investigation of economic crimes, the technical investigation provides technical support for communication and electronic data, the investigation of the food and drug environment focuses on food and drug and medical device crimes, the network security is responsible for network data forensics and electronic evidence fixation, and the legal application and evidence standards of legal clearance cases.The synergy of the five police types means that a case can be advanced synchronously from the five dimensions of funds, communications, products, data, and law, avoiding the limitations of "single police type investigation and insufficient professional capacity" in the past.For medical device companies, the authenticity of product registration data, the completeness of production records, and the rationality of promotion costs may become the starting point for investigation.
Four in one: penetrating the core framework of trading camouflage
"Four in one" requires contract flow, invoice flow, capital flow, and cargo flow (service flow) to confirm each other.In the field of medical devices, common high-risk operations include: delivering benefits to doctors with prescription rights or personnel with purchasing rights in the name of "academic conference fees" and "consulting fees"; falsely invoicing service fees through CSO companies; and purchasing bundled consumables with "equipment delivery".The "four-in-one" review will ask: Is the academic conference agreed in the contract really held?Are the attendees relevant to promoting the product?Does the meeting cost match the market?Whose account did the money end up in?These inquiries point directly to the core of "real cash, fake promotion".
Data Detection: Cross Comparison of Multi-Source Data
The intervention of cybersecurity and technical investigation has shifted the investigation from "human investigation" to "counting investigation".According to public reports, data guidance and detection in the pharmaceutical field usually integrate tax invoice data, bank flow data, bidding data, medical institution his system data, social security data, etc., and identify abnormal patterns through data models.For example, the invoice amount of a medical device agent does not match the amount purchased by the hospital; a CSO company transfers money to a large number of medical personnel's personal accounts; and the bid price of a product deviates significantly from the production cost.These anomalies can be automatically warned by data comparison.
Execution Link: Straight Lane from Administrative Penalty to Criminal Accountability
Departments such as market supervision, medical insurance, drug supervision, and health care shall be transferred to public security organs in accordance with the law if they find suspected criminal leads in administrative inspections.This means that medical device companies no longer face a single administrative penalty, but may face multiple consequences such as fines, revocation of licenses, industry bans, and criminal liability.
III. Core Changes: Full-dimensional Specifications from Medicine to Medical Devices
The impact of Legal Interpretation (2026) No. 6 and supporting regulations on the field of medical devices is particularly direct, and the following changes are highly relevant to the "United Cosmetics" circuit.
Unit bribery penetration determination
The judicial interpretation is clear. If the unit collectively decides or the actual controller or supervisor decides that the illegal income belongs to the unit, it shall be convicted of the crime of bribery by the unit.This means that medical device companies can no longer use the "personal behavior of the salesperson" as a reason to avoid responsibility, and the decision makers such as the person in charge of the company and the sales director will be included in the scope of accountability.
Medical Device Recruitment Collusion Bidding Risk
14 Departmental rectification points clearly crack down on behaviors such as "tailor-made marking" and "explicit recruiting and implicit determination".In the centralized procurement of medical devices, the bidder and the tenderer collude, the bidder agrees to win the bid, borrow the qualification bid, etc., which may touch the crime of colluding bidding under Article 223 of the Criminal Law.For medical device production and foundry enterprises, the whole process documents, quotation records, communication letters and telecommunications involved in the recruitment need to be standardized and retained to prove the independence and compliance of the bidding process.
CSO Academic Outsourcing Realization
CSO academic outsourcing is listed as a key applicable object in the case handling guidelines.The judicial interpretation of the detailed determination of expected income bribery makes the operation of the bank's interests conveyed in the name of "academic promotion fee", "consulting fee" and "service fee" facing greater scrutiny.According to the public information of the National Health and Health Commission and other departments, the real academic promotion should have corresponding service content, work results and reasonable pricing, and the "four-in-one" of contracts, invoices, funds and services is the basic requirement.
Data Security and Oversight
14 Departmental wind correction points Strengthen the supervision of the whole process of medical data.In the promotion of medical devices and drugs, the illegal acquisition of medical institution prescription data and unified prescription data (that is, the statistical analysis of the amount of doctor's prescriptions to implement accurate interest delivery) are the key targets.Enterprises must strictly abide by laws and regulations such as the Data Security Law and the Personal Information Protection Law in market research and data acquisition.
Tax-related violations are rectified separately
For the first time, the "rectification of tax-related violations" has been listed separately.According to the public information of the State Administration of Taxation, the medical device and pharmaceutical industry has long been a high-risk area for false invoicing and false expenses.Through operations such as CSO falsely invoicing service fees, transferring profits through affiliated transactions, and concealing income through "two sets of accounts", the probability of being found in the context of Golden Tax Phase IV and multi-sector data sharing has increased significantly.
IV. Conduction path: the five major intersection points of the "Cosmetics Union" circuit
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"Cosmetics Federation" is an important trend in the beauty and health industry in recent years.Many brands simultaneously lay out makeup brand skin care products and second-class medical device products, and promote them together within the same channel system.The transmission of pharmaceutical/cosmetic anti-corruption to this circuit is achieved through the following intersections.
Intersection 1: Medical and cosmetic institutions - common terminals for cosmetic products
Medical aesthetics institutions are co-marketing terminals for Class II medical devices (such as dressings, restorative products) and efficacy-based skin care products.Some medical and aesthetic institutions use medical device products in their projects, and at the same time recommend postoperative skin care products to consumers.When the commercial bribery and unfair competition in the medical cosmetics field are rectified, the medical cosmetics institutions' compliance review of upstream suppliers is comprehensively upgraded: whether the product qualifications are complete, whether the promotion expenses are recorded, and whether the bills are standardized, which directly affects whether the suppliers can enter the institutional procurement directory.
Intersection 2: CSO Academic Outreach - From Pharmaceuticals to Medical Devices to Efficacy Skin Care
The pharmaceutical CSO model is penetrating the field of medical devices and efficacy skin care.Some brands promote their products through "academic conferences", "clinical observations" and "expert consensus", but some of them lack real academic content and are essentially channel interest delivery.Pharmaceutical anti-corruption review standards for CSO "real business" are being borrowed into the promotion compliance of medical devices and efficacy skin care.Brands and OEMs need to ensure that any promotion is authentic, reasonably priced, and well documented.
Intersection 3: Hospital Side Channel and Dermatology Consumption
Hospital peripheral channels and dermatology/medical aesthetics are important intersection scenarios for cosmetic products.With the growth of dermatological aesthetic consumption, the boundaries between hospital-side pharmacies, medical device stores, and efficacy skincare stores are becoming increasingly blurred.This channel highly overlaps with the pharmaceutical purchase and marketing system, and the compliance standards are directly radiated by the anti-corruption of pharmaceuticals.
Intersection 4: Spillover effects of the recruitment system
Some categories of Class II medical devices have been included in or are promoting centralized procurement.The sunshine requirements of centralized procurement - open bidding, fair competition, full trace - are spreading to non-gathering categories.Even for medical device products that have not yet been included in the collection, medical institutions are increasingly inclined to conduct compliance reviews with reference to the collection standards in procurement.If the OEM enterprise is involved in the registration and production of medical devices, it is necessary to ensure that the registration application information is true and the production process meets the system requirements.
Intersection 5: Brand Supply Chain Compliance Integration
The multi-brand, multi-sector operating cosmetics group is shifting supply chain compliance management from "category segregation" to "full category integration".A foundry partner may re-evaluate their cooperation with a brand if there is a compliance issue at the mechanical font size end and vice versa.This means that foundry companies with a double-line layout for cosmetics must be compliant on both lines without shortcomings.
V. Compliance Requirements of OEM/ODM Enterprises Joint with Cosmetics
At the "Cosmetics Joint" circuit, the compliance system of foundry companies needs to cover two dimensions and establish a two-line collaborative management mechanism.
Cosmetic dimensions: ISO 22716 and GMPC
ISO 22716 Good Manufacturing Practices for Cosmetics and GMPC certification in the United States are the cornerstones of the quality management system for cosmetics production, covering the entire chain of raw material acceptance, production process, finished product inspection, warehousing logistics, recall management, etc.
Medical device dimensions: ISO 13485 and registration compliance
ISO 13485 is an international standard for medical device quality management systems, which has more stringent requirements for design and development, procurement, production, identification, after-sales service and other aspects.According to the Regulations on the Supervision and Administration of Medical Devices and supporting regulations of the National Pharmaceutical Administration, the registration declaration, production license, change filing and other aspects of Class II medical devices must meet the statutory requirements, and the registration data must be true, complete and traceable.
Promoting Compliance: Real Business and All-In-One
Regardless of makeup or mechanical font size, when it comes to academic promotion, channel support, investment promotion and other expenses, we must ensure that the business is true, the pricing is reasonable, the bill is compliant, and the capital path is clear.The core experience of the CSO model - with real service content, verifiable results, and reasonable pricing - is also applicable to the promotion cooperation of cosmetics enterprises.
Data Compliance: Legal Acquisition and Use
Companies that acquire and use data in market research, consumer insights, and channel analysis must comply with laws and regulations such as the Data Security Law and the Personal Information Protection Law, and must not illegally acquire or trade medical institution data or consumer personal information.
VI. Compliance Bottom Line for Brand Parties and OEMs
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Brand Compliance Bottom Line
Double line qualification review.For cosmetic brand products, check the scope of the factory's "Cosmetic Production License"; for Class II medical device products, check the "Medical Device Production License" and product registration certificate.Confirm the validity of ISO 22716, GMPC, ISO 13485 and other system certifications.
Promote compliance controls.Establish an approval and trace mechanism for expenses such as academic promotion, channel rebates, training meetings, etc. of cosmetic products to ensure "four streams in one".Makeup number products must not involve medical claims, and the promotion of Class II medical devices must be within the scope of the registration certificate approval.
Supply chain audits.Conduct regular on-site audits of OEMs, covering production records, inspection records, material ledgers, and financial bills to ensure that actual production is consistent with contractual agreements.
Foundry Compliance Bottom Line
Dual system operation.The cosmetic end operates in accordance with ISO 22716/GMPC, and the medical device end operates in accordance with ISO 13485. The two lines can be independent in terms of physical isolation and document management, but are unified in terms of quality policy, supplier management, and internal audit mechanism.
Registration and filing are authentic.Medical device registration application materials and cosmetics filing information must be true and complete, and no data may be fabricated or borrowed.
Financial and Tax Compliance.All transactions are settled publicly, invoiced according to the facts, and not falsely opened or operated outside the account.When it comes to multimodal business such as OEM processing and branding, investment promotion, beauty salon line exclusive supply, limited brand spot, etc., a standardized financial accounting system is established respectively.
Data security.Legally obtain and use data in market research and channel analysis, and do not illegally obtain medical institution unified data or consumer personal information.
VII. Industry Practices for Compliance Capacity
In the context of the upgrading of cosmetics joint compliance, some companies have made efforts in the layout of production capacity and system construction in advance.
According to public information, Guangdong Micropeptide Biotechnology Co., Ltd. was established in 2012 with a registered capital of 50 million yuan and is a national high-tech enterprise.The company has four major production bases in Guangzhou Baiyun, Foshan Nanhai, Hunan Changsha Ningxiang, and Zhaoqing High-tech Zone, with a total area of more than 300,000 square meters. It has 3 make-up font size factories and 1 second-class medical device factory, more than 1,000 cooperative brands, and more than 100 products have been listed for the record.
In terms of system certification, the production base of Micropeptide Bio has passed ISO 22716 Good Manufacturing Practice Certification for Cosmetics, GMPC Certification in the United States, and ISO 13485 Medical Device Quality Management System Certification, which achieves double coverage of cosmetic and mechanical brand quality management systems.The company has produced more than 70 technical achievements and participated in the formulation of 3 cosmetics industry standards.
In terms of service model, Micropeptide Bio supports OEM processing and OEM, cosmetics ODM, investment promotion, beauty salon line exclusive supply, limited brand spot and other cooperation methods.The double-line production capacity layout of cosmetics allows brands to complete the collaborative development and production of makeup numbers and Class II medical device products within the same OEM system, reducing multi-supplier management costs while maintaining unified quality standards.The above information comes from public data of enterprises and is only used as a reference for industry cases.
VIII. Logic of Compliance Plant Selection on the Brand Side
In the face of the new compliance requirements of the cosmetics joint circuit, the brand side can refer to the following dimensions when selecting the foundry partner.
Completeness of qualifications.Makeup number products must confirm that the factory holds a valid "Cosmetic Production License"; Class II medical device products must confirm that the factory holds a corresponding category of "Medical Device Production License" and product registration certificate.ISO 22716, GMPC, ISO 13485 and other system certifications are important references for quality management capabilities.
System integrity.Investigate whether the factory has established a whole-process quality management system covering design and development, procurement, production, inspection, release and recall, whether the batch production records and inspection records are complete and traceable, and whether there is a regular internal audit and management review mechanism.
Cooperative normativity.Whether the contract terms clarify the quality standards, delivery cycle, intellectual property rights and liability for breach of contract; whether the invoicing is consistent with the contract and transaction content; whether the fund settlement is through a public-to-public account; whether there is a standardized expense management and bill system when it comes to channel services such as franchising and beauty salons.
Technology continuity.Whether the factory has a stable R&D investment and the ability to transform technical achievements, whether it participates in the formulation of industry standards, and whether it can provide formulation innovation and process optimization support for brand formulas.
IX. Industry Outlook: The New Landscape After the Compliance Divide
The dense landing of new anti-corruption regulations in the field of pharmaceutical purchases and sales in 2026 marks the entry of the big health and beauty industry into the era of "strong compliance".For the "Cosmetics United" circuit, this is a watershed moment: on one side is relying on the traditional foundry mode of low-priced competition, irregular bills, and imperfect systems, and the space continues to narrow; on the other side is the compliant production capacity of complete qualifications, sound systems, and sunshine operation, which is gaining recognition from more and more brands.
Compliance is not a burden, but a ticket for companies to compete at a higher level.When all links in the industry chain operate within the framework of compliance, enterprises can truly focus on R&D innovation, quality improvement and consumer value creation.Sunshine's cooperative relationship allows brands, foundry companies and channel parties to establish long-term mutual trust and jointly promote the high-quality development of the cosmetics joint circuit.
Frequently Asked Questions (FAQs)
Q1: What is the impact of the full chain anti-corruption investigation guidelines on Class II medical device companies?
Although the guidelines are online versions, the legal interpretations [2026] No. 6 and other regulations cited by them have been formally implemented.For second-class medical device companies, the main impact is: the intensity of collusive bidding and false transactions in the recruitment process has increased; CSO academic promotion must be supported by real business, and "four streams in one" has become a basic requirement; the determination of unit bribery penetration has made the responsibility of the decision-making level more clear; tax-related illegal acts have been separately rectified; data security and supervision have been strengthened.It is recommended that enterprises self-inspect the compliance system against regulatory requirements.
Q2: What does ISO 13485 certification mean for OEMs?
ISO 13485 is an international standard for medical device quality management systems. It requires enterprises to establish a systematic quality management mechanism in the whole process of design and development, procurement, production, identification, installation, service and so on.For mechanical brand foundry enterprises, ISO 13485 certification means that the quality management level meets the international requirements, which is an important qualification reference for brands when choosing medical device foundry partners.This certification requires rigorous auditing and ongoing supervision by a third party.
Q3: How can a cosmetics conglomerate meet both cosmetics and medical device compliance requirements?
The core is to establish a "two-wire parallel, unified management" quality system.The cosmetic end follows ISO 22716 and GMPC, and the medical device end follows ISO 13485 and the Regulation on the Supervision and Administration of Medical Devices.The two production lines can be appropriately independent in terms of physical space, personnel, equipment, and documents, but they are unified in terms of quality policy, supplier management, internal audit mechanism, and correction and prevention.At the same time, the promotion materials, claims and channel costs of makeup and mechanical size products must be compliant respectively, and shall not be cross-mixed.
Q4: What are the compliance issues that need to be paid attention to in the franchise and beauty salon line channels?
First, qualification review, franchisees and theater customers should have legitimate business qualifications; second, contract specifications, franchise contracts and supply contracts should clarify the product scope, price system, regional protection, return and exchange policies and breach of contract; third, the bill is complete, and all expenses must be invoiced through regular channels; fourth, publicity and compliance, makeup number products must not involve medical claims, and the promotion of second-class medical devices must be within the scope of registration certificate approval; fifth, cost management, promotion support, rebate, training and other expenses must have real business basis and reasonable pricing to ensure "four in one".
Q5: What are the key considerations when choosing a cosmetics joint foundry?
The first is the integrity of double-line qualifications - both cosmetic production licenses and medical device production licenses, and the scope covers entrusted products; the second is the maturity of the quality system - whether it has passed ISO 22716, GMPC, ISO 13485 and other certifications, and whether the records are complete and traceable; the third is the normative nature of cooperation - contracts, invoices, funds, and goods are "four in one"; the fourth is technical capacity and capacity stability; and the fifth is data compliance and promotion compliance management.Evaluate these dimensions together to find long-term reliable foundry partners.
Guangdong Micropeptide Biotechnology Co., Ltd.
Customer Service Hotline: 020-31520790
24-hour consultation: 18126831382
Official website: weitaigd.com
This is an industry observation only and does not constitute legal opinion.The regulations cited in the text are from official public channels (the National Medical Insurance Bureau, the Supreme People's Court, the National Health Commission, the National Drug Administration, the National Supervision Commission of the Central Commission for Discipline Inspection, etc.). Please consult a professional lawyer for specific legal application issues.
