In August 2026, a document titled "Guidelines for Full-Chain Investigation and Case Handling of Commercial Bribery and Related Crimes in the Field of Pharmaceutical Procurement" circulated in the industry. This case-handling guideline, reportedly formulated through collaboration among five police categories—economic crime investigation, technical investigation, food-drug-environment investigation, cybersecurity, and legal affairs—establishes "full-chain penetration, four-flow integration, data-guided investigation, administrative-criminal linkage, and closed-loop enforcement" as the core of case handling. Its scope covers the entire spectrum of business formats, including pharmaceutical distribution, investment promotion agencies, two-invoice delivery, CSO academic outsourcing, high-value consumables general agents, hospital-end pure sales, hospital-adjacent channels, grassroots allocation, internet hospitals, patient assistance programs, and the medical representative filing system.
Although this guideline is currently an online-circulated version, many of the regulations it cites have already been formally implemented. For enterprises in the "cosmetics-device combination" track, these regulations not only reshape the compliance ecosystem in the pharmaceutical and medical device fields, but their transmission effects are also changing the industry rules for combined contract manufacturing of cosmetics and medical devices.
I. Regulatory Context: Accelerated Improvement of the Institutional System
Amendment (XII) to the Criminal Law: Statutory Aggravated Punishment for Bribery in the Medical Field
On March 1, 2024, Amendment (XII) to the Criminal Law officially took effect. According to the announcement of the Standing Committee of the National People's Congress, the amendment explicitly lists "offering bribes in the medical field" as a statutory circumstance for aggravated punishment, establishing at the criminal legislative level the tone of strict punishment for bribery in the medical field.
Judicial Interpretation [2026] No. 6: Conviction Standards and Unit Penetration
On April 10, 2026, the Supreme People's Court and the Supreme People's Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Law in Handling Criminal Cases of Embezzlement and Bribery (II)" (Judicial Interpretation [2026] No. 6), effective from May 1, 2026. According to information published on the official website of the National Healthcare Security Administration (nhsa.gov.cn), the judicial interpretation clarifies:
- Unit bribery of 200,000 yuan or more is recognized as "serious circumstances," and 2 million yuan or more as "especially serious circumstances";
- Bribery in food and drug, medical, and other fields constitutes a statutory aggravating circumstance;
- The sentencing standards for the crime of accepting bribes by non-state functionaries and the crime of offering bribes to non-state functionaries shall refer to those for the crime of accepting bribes and the crime of offering bribes;
- Where a unit collectively decides, or the actual controller or person in charge decides, and the illegal gains belong to the unit, the unit shall be convicted and punished for the crime of unit bribery, closing off the path of cutting off liability as "individual employee behavior";
- Refine the rules for determining the amount of expected-benefit bribery such as equity and options.
According to the explanation on the official website of the Supreme People's Court, the interpretation aligns the sentencing standards for the crime of accepting bribes by non-state functionaries with those for state functionaries, meaning that the sentencing standards for sales personnel and procurement personnel in pharmaceutical and medical device enterprises who accept kickbacks by taking advantage of their positions will be significantly raised.
Five-Department Integrity Governance Regulations and 14-Department Correction Priorities
On May 1, 2026, the "Several Provisions on Integrity Governance in the Field of Pharmaceutical Procurement," jointly issued by the Central Commission for Discipline Inspection and the National Supervisory Commission, the National Health Commission, the National Healthcare Security Administration, the National Medical Products Administration, and the State Administration for Market Regulation, officially took effect. According to a notice on the website of the Central Commission for Discipline Inspection and the National Supervisory Commission, the provisions cover the entire chain of pharmaceutical procurement, production, circulation, and use, and are a landmark document for multi-departmental joint systematic promotion of integrity governance.
On June 8, 2026, the National Health Commission and 14 other departments jointly issued the "Key Work Points for Correcting Unhealthy Tendencies in the Field of Pharmaceutical Procurement and Medical Services in 2026." According to public information on the official website of the National Health Commission, the key points focus on rectifying illegal interference by the "key minority" of purchasers, splitting projects to evade public bidding, tailor-made bidding, and "open bidding with predetermined winners"; cracking down on bidders' renting of licenses, false transactions, and commercial bribery; for the first time listing "rectification of tax-related illegal acts" as a separate item; and strengthening full-process supervision of medical data.
At the industry regulatory level, according to the National Healthcare Security Administration's "Pharmaceutical Price and Procurement Credit Evaluation System," a bribe amount of 10,000 yuan is sufficient to be listed as dishonest, facing penalties such as cancellation of online listing and centralized procurement qualifications. Regarding the retrospective mechanism, violations are subject to a 5-year retrospective review, and those involving major losses to the medical insurance fund can be traced back 20 years; retirement, resignation, or transfer does not exempt liability.
II. In-Depth Interpretation of the Case-Handling Model: Five-Police-Category Collaboration and Data-Guided Investigation
The upgrade of the investigation model reflected in the online-circulated case-handling guidelines has important signaling significance for medical device and cosmetics-device combination enterprises.
Professional Coverage of Five-Police-Category Collaboration
Economic crime investigation is responsible for investigating economic crimes; technical investigation provides technical support for communications and electronic data; food-drug-environment investigation focuses on food, drug, and medical device crimes; cybersecurity is responsible for network data forensics and electronic evidence preservation; and legal affairs reviews the legal application and evidence standards of cases. The collaboration of five police categories means that a case can be advanced simultaneously from five dimensions—funds, communications, products, data, and law—avoiding the past limitation of "single-police-category investigation with insufficient professional capacity." For medical device enterprises, the authenticity of product registration materials, the completeness of production records, and the reasonableness of promotion expenses may all become entry points for investigation.
Four-Flow Integration: The Core Framework for Penetrating Transaction Disguises
"Four-flow integration" requires mutual corroboration among the contract flow, invoice flow, fund flow, and goods flow (service flow). In the medical device field, common high-risk operations include: transferring benefits to doctors with prescribing rights or personnel with procurement authority under the names of "academic conference fees" or "consulting fees"; obtaining funds through CSO companies issuing false service fee invoices; and bundling consumables procurement with "equipment placement." The "four-flow integration" review will ask: Was the academic conference stipulated in the contract actually held? Are the participants related to the promoted products? Do the conference expenses match market rates? Whose account did the funds ultimately flow to? These questions directly target the core of "real cash-out, fake promotion."
Data-Guided Investigation: Cross-Comparison of Multi-Source Data
The involvement of cybersecurity and technical investigation has shifted investigation from "people investigating cases" to "data investigating cases." According to public reports, data-guided investigation in the pharmaceutical field typically integrates tax invoice data, bank transaction data, bidding data, hospital HIS system data, social security data, etc., and identifies abnormal patterns through data models. For example: the invoice amount of a medical device agent does not match the hospital's procurement volume; a CSO company transfers funds to a large number of medical personnel's personal accounts; the winning bid price of a product seriously deviates from production costs. These anomalies can be automatically alerted through data comparison.
Administrative-Criminal Linkage: A Direct Lane from Administrative Penalties to Criminal Liability
When departments such as market regulation, healthcare security, drug administration, and health commission discover suspected criminal clues during administrative inspections, they must transfer them to public security organs in accordance with the law. This means that medical device enterprises no longer face a single administrative penalty, but may face multiple consequences including fines, license revocation, industry bans, and criminal liability.
III. Core Changes: All-Dimensional Regulation from Pharmaceuticals to Medical Devices
Judicial Interpretation [2026] No. 6 and supporting regulations have a particularly direct impact on the medical device field. The following changes are highly relevant to the "cosmetics-device combination" track.
Penetrating Determination of Unit Bribery
The judicial interpretation clarifies that where a unit collectively decides, or the actual controller or person in charge decides, and the illegal gains belong to the unit, the unit shall be convicted of the crime of unit bribery. This means that medical device enterprises can no longer evade responsibility on the grounds of "individual behavior of salespersons," and decision-makers such as enterprise heads and sales directors will be included in the scope of accountability.
Bid Rigging Risks in Medical Device Procurement
The 14-department correction priorities explicitly crack down on "tailor-made bidding" and "open bidding with predetermined winners." In centralized procurement of medical devices, collusion between bidders and tendering parties, agreements among bidders on winning bids, and borrowing qualifications to bid may constitute the crime of bid rigging under Article 223 of the Criminal Law. For medical device manufacturers and contract manufacturers, all process documents, quotation records, and correspondence involved in procurement must be properly retained to prove the independence and compliance of the bidding process.
Authenticity of CSO Academic Outsourcing
The case-handling guidelines list CSO academic outsourcing as a key applicable object. The refined determination of expected-benefit bribery in the judicial interpretation subjects operations that use "academic promotion fees," "consulting fees," and "service fees" as a cover for benefit transfer to stricter review. According to public information from the National Health Commission and other departments, genuine academic promotion should have corresponding service content, work outputs, and reasonable pricing, and the "four-flow integration" of contract, invoice, funds, and services is a basic requirement.
Data Security and Prescription Statistics Supervision
The 14-department correction priorities strengthen full-process supervision of medical data. In medical device and drug promotion, illegally obtaining medical institution prescription data or prescription statistics data (i.e., statistical analysis of doctors' prescription volumes to implement precise benefit transfer) is a key target of enforcement. Enterprises must strictly comply with laws and regulations such as the Data Security Law and the Personal Information Protection Law in market research and data acquisition.
Separate Rectification of Tax-Related Violations
For the first time, the correction priorities list "rectification of tax-related illegal acts" as a separate item. According to public information from the State Taxation Administration, the medical device and pharmaceutical industries have long been high-risk areas for false invoicing and falsely listed expenses. Operations such as issuing false service fee invoices through CSOs, transferring profits through related-party transactions, and concealing income through "two sets of accounts" are significantly more likely to be discovered under the background of the fourth phase of the Golden Tax System and multi-department data sharing.
IV. Transmission Paths: Five Intersections of the "Cosmetics-Device Combination" Track
"Cosmetics-device combination" is an important trend in the beauty and health industry in recent years. Many brands simultaneously deploy cosmetics-brand skincare products and Class II medical device products, promoting them synergistically within the same channel system. The transmission of anti-corruption efforts in pharmaceuticals/medical aesthetics to this track is realized through the following intersections.
Intersection 1: Medical Aesthetics Institutions—Common Terminals for Cosmetics and Device Products
Medical aesthetics institutions are common sales terminals for Class II medical devices (such as dressings and repair products) and functional skincare products. Some medical aesthetics institutions use medical device products in procedures while recommending post-procedure repair skincare products to consumers. As commercial bribery and unfair competition in the medical aesthetics field are subject to focused rectification, medical aesthetics institutions' compliance review of upstream suppliers has comprehensively upgraded: whether product qualifications are complete, whether promotion expenses are recorded, and whether invoices are standardized directly affect whether suppliers can enter the institution's procurement list.
Intersection 2: CSO Academic Promotion—From Drugs to Medical Devices to Functional Skincare
The pharmaceutical CSO model is penetrating into the medical device and functional skincare fields. Some brands promote products through "academic conferences," "clinical observations," and "expert consensus," but some of these lack genuine academic content and are essentially channel benefit transfer. The review standards of pharmaceutical anti-corruption for CSO "genuine business" are being borrowed for promotion compliance in medical devices and functional skincare. Brand owners and contract manufacturers need to ensure that any promotional activity has genuine content, reasonable pricing, and complete records.
Intersection 3: Hospital-Adjacent Channels and Dermatology Consumption
Hospital-adjacent channels and dermatology/medical aesthetics departments are important convergence scenarios for cosmetics and device products. With the growth of dermatology medical aesthetics consumption, the boundaries among hospital-adjacent pharmacies, medical device stores, and functional skincare stores are increasingly blurred. This channel highly overlaps with the pharmaceutical procurement system, and compliance standards are directly radiated by pharmaceutical anti-corruption efforts.
Intersection 4: Spillover Effects of the Procurement System
Some categories of Class II medical devices have been included in or are being advanced toward centralized procurement. The transparency requirements of centralized procurement—open bidding, fair competition, and full-process traceability—are spreading to non-centralized procurement categories. Even for medical device products not yet included in centralized procurement, medical institutions are increasingly inclined to conduct compliance reviews with reference to centralized procurement standards. Contract manufacturers involved in medical device registration and production need to ensure that registration application materials are authentic and that the production process meets system requirements.
Intersection 5: Integrated Supply Chain Compliance for Brand Owners
Cosmetics groups operating multiple brands and categories are shifting supply chain compliance management from "separation by category" to "full-category integration." If a contract manufacturing partner has compliance issues on the device-brand side, the brand owner may reassess its cooperation on the cosmetics-brand side, and vice versa. This means that contract manufacturers with dual cosmetics-device layouts must achieve compliance with no shortcomings on both lines.
V. Compliance Requirements for Cosmetics-Device Combination OEM/ODM Enterprises
In the "cosmetics-device combination" track, the compliance system of contract manufacturers needs to cover two dimensions and establish a dual-line collaborative management mechanism.
Cosmetics Dimension: ISO 22716 and GMPC
ISO 22716 Good Manufacturing Practices for Cosmetics and US GMPC certification are the cornerstones of the cosmetics production quality management system, covering the entire chain from raw material acceptance, production process, finished product inspection, warehousing and logistics, to recall management.
Medical Device Dimension: ISO 13485 and Registration Compliance
ISO 13485 is the international standard for medical device quality management systems, with stricter requirements for design and development, procurement, production, labeling, and after-sales service. According to the National Medical Products Administration's "Regulations on the Supervision and Administration of Medical Devices" and supporting regulations, the registration application, production licensing, and change filing of Class II medical devices must comply with statutory requirements, and registration materials must be authentic, complete, and traceable.
Promotion Compliance: Genuine Business and Four-Flow Integration
Whether for cosmetics-brand or device-brand products, when expenses such as academic promotion, channel support, and investment promotion agency fees are involved, it is necessary to ensure that the business is genuine, pricing is reasonable, invoices are compliant, and fund paths are clear. The core experience of the CSO model—having genuine service content, verifiable outputs, and a reasonable pricing basis—is equally applicable to the promotion cooperation of cosmetics-device combination enterprises.
Data Compliance: Lawful Acquisition and Use
Enterprises acquiring and using 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 obtain or trade medical institution data or consumers' personal information.
VI. Compliance Bottom Lines for Brand Owners and Contract Manufacturers
Compliance Bottom Lines for Brand Owners
Dual-line qualification review. For cosmetics-brand products, verify the scope of the factory's Cosmetics Production License; for Class II medical device products, verify the Medical Device Production License and product registration certificate. Confirm the validity of system certifications such as ISO 22716, GMPC, and ISO 13485.
Promotion compliance control. Establish approval and record-keeping mechanisms for expenses such as academic promotion, channel rebates, and training conferences for cosmetics and device products, ensuring "four-flow integration." Cosmetics-brand products must not involve medical claims, and promotion of Class II medical devices must be within the approved scope of the registration certificate.
Supply chain audit. Conduct regular on-site audits of contract manufacturers, covering production records, inspection records, material ledgers, and financial invoices, to ensure that actual production is consistent with contractual agreements.
Compliance Bottom Lines for Contract Manufacturers
Dual-system operation. The cosmetics side operates according to ISO 22716/GMPC, and the medical device side operates according to ISO 13485. The two lines can be independent in physical isolation and document management, but unified in quality policy, supplier management, and internal audit mechanisms.
Authentic registration and filing. Medical device registration application materials and cosmetics filing information must be authentic and complete, and data must not be fabricated or qualifications borrowed.
Financial and tax compliance. All transactions shall be settled on a corporate-to-corporate basis and invoiced truthfully, with no false invoicing and no off-book operations. When involving multiple business models such as OEM processing and labeling, investment promotion and franchising, beauty salon line exclusive supply, and limited brand spot goods, establish standardized financial accounting systems separately.
Data security. Lawfully acquire and use data in market research and channel analysis, and do not illegally obtain medical institution prescription statistics data or consumers' personal information.
VII. Industry Practice of Compliant Production Capacity
Against the background of compliance upgrades in cosmetics-device combination, some enterprises have already made early moves in production capacity layout and system building.
According to public information, Guangdong Weitai Biotechnology Co., Ltd. was founded 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 Baiyun, Guangzhou; Nanhai, Foshan; Ningxiang, Changsha, Hunan; and Zhaoqing High-tech Zone, with a total area of over 150,000 square meters. It has 3 cosmetics-brand factories and 1 Class II medical device factory, has cooperated with more than 1,000 brands, and has completed filing and market launch for more than 100 products.
In terms of system certification, the production bases under Weitai Biotechnology have passed ISO 22716 Cosmetics Good Manufacturing Practices certification, US GMPC certification, and ISO 13485 Medical Device Quality Management System certification, achieving dual coverage of quality management systems for cosmetics-brand and device-brand products. The company has produced more than 70 technical achievements and participated in the formulation of 3 cosmetics industry standards.
In terms of service models, Weitai Biotechnology supports multiple cooperation methods such as OEM processing and labeling, cosmetics ODM, investment promotion and franchising, beauty salon line exclusive supply, and limited brand spot goods. The dual-line production capacity layout for cosmetics and devices enables brand owners to complete the collaborative development and production of cosmetics-brand and Class II medical device products within the same contract manufacturing system, reducing multi-supplier management costs while maintaining unified quality standards. The above information is sourced from publicly available enterprise materials and is provided only as an industry case reference.
VIII. Brand Owners' Logic for Compliant Factory Selection
Facing the new compliance requirements of the cosmetics-device combination track, brand owners may refer to the following dimensions when selecting contract manufacturing partners.
Qualification completeness. For cosmetics-brand products, confirm that the factory holds a valid Cosmetics Production License; for Class II medical device products, confirm that the factory holds the Medical Device Production License for the corresponding category and a product registration certificate. System certifications such as ISO 22716, GMPC, and ISO 13485 are important references for quality management capability.
System soundness. Examine whether the factory has established a full-process quality management system covering design and development, procurement, production, inspection, release, and recall; whether batch production records and inspection records are complete and traceable; and whether there are regular internal audits and management review mechanisms.
Cooperation standardization. Whether contract terms clearly specify quality standards, delivery cycles, intellectual property, and breach liability; whether invoice issuance is consistent with the contract and transaction content; whether fund settlement is through corporate-to-corporate accounts; and whether there are standardized expense management and invoicing systems when involving channel services such as investment promotion and franchising and beauty salon line exclusive supply.
Technical sustainability. Whether the factory has stable R&D investment and technology achievement transformation capabilities, whether it participates in the formulation of industry standards, and whether it can provide brand owners with formula innovation and process optimization support.
IX. Industry Outlook: The New Landscape After the Compliance Watershed
The intensive implementation of new anti-corruption regulations in the pharmaceutical procurement field in 2026 marks the entry of the health and beauty industry into an era of "strong compliance." For the "cosmetics-device combination" track, this is a watershed: on one side, the traditional contract manufacturing model relying on low-price competition, non-standard invoices, and unsound systems is seeing its space continuously narrow; on the other side, compliant production capacity with complete qualifications, sound systems, and transparent operations is gaining recognition from more and more brand owners.
Compliance is not a burden, but an admission ticket for enterprises to participate in higher-level competition. When all links in the industrial chain operate within the compliance framework, enterprises can truly focus on R&D innovation, quality improvement, and consumer value creation. Transparent cooperation allows brand owners, contract manufacturers, and channel parties to establish long-term mutual trust and jointly promote the high-quality development of the cosmetics-device combination track.
Frequently Asked Questions (FAQ)
Q1: What impact does the full-chain anti-corruption investigation guideline have on Class II medical device enterprises?
Although the guideline is an online-circulated version, the regulations it cites, such as Judicial Interpretation [2026] No. 6, have all been formally implemented. For Class II medical device enterprises, the main impacts are: increased enforcement against bid rigging and false transactions in procurement; CSO academic promotion must have genuine business support, and "four-flow integration" has become a basic requirement; penetrating determination of unit bribery makes decision-makers' responsibilities clearer; tax-related illegal acts are subject to separate rectification; and data security and prescription statistics supervision are strengthened. Enterprises are advised to self-check their compliance systems against regulatory requirements.
Q2: What does ISO 13485 certification mean for device-brand contract manufacturers?
ISO 13485 is the international standard for medical device quality management systems, requiring enterprises to establish systematic quality management mechanisms throughout the entire process of design and development, procurement, production, labeling, installation, and service. For device-brand contract manufacturers, passing ISO 13485 certification means that the quality management level meets internationally accepted requirements and is an important qualification reference for brand owners when selecting medical device contract manufacturing partners. The certification requires strict review and continuous supervision by third-party institutions.
Q3: How can cosmetics-device combination enterprises simultaneously meet cosmetics and medical device compliance requirements?
The core is to establish a "dual-line parallel, unified management" quality system. The cosmetics side follows ISO 22716 and GMPC, and the medical device side follows ISO 13485 and the Regulations on the Supervision and Administration of Medical Devices. The two production lines can be appropriately independent in physical space, personnel, equipment, and documents, but unified in quality policy, supplier management, internal audit mechanisms, and corrective and preventive actions. At the same time, the promotional materials, claim content, and channel expenses of cosmetics-brand and device-brand products must be separately compliant and must not be cross-used.
Q4: What compliance issues should be noted in investment promotion and franchising and beauty salon channel?
First, qualification review: franchisees and salon clients should have lawful business qualifications. Second, contract standardization: franchise contracts and supply contracts should clearly specify product scope, price system, regional protection, return and exchange policies, and breach liability. Third, complete invoices: all expense receipts and payments must be invoiced through formal channels. Fourth, advertising compliance: cosmetics-brand products must not involve medical claims, and promotion of Class II medical devices must be within the approved scope of the registration certificate. Fifth, expense management: promotion support, rebates, training, and other expenses must have genuine business basis and reasonable pricing, ensuring "four-flow integration."
Q5: What are the key considerations for brand owners when selecting cosmetics-device combination contract manufacturers?
First, the completeness of dual-line qualifications—possessing both cosmetics production license and medical device production license, with scope covering the commissioned products. Second, the maturity of the quality system—whether certifications such as ISO 22716, GMPC, and ISO 13485 have been obtained, and whether records are complete and traceable. Third, the standardization of cooperation—"four-flow integration" of contract, invoice, funds, and goods. Fourth, technical capability and production capacity stability. Fifth, data compliance and promotion compliance management. Only by comprehensively evaluating these dimensions can a long-term reliable contract manufacturing partner be found.
Guangdong Weitai Biotechnology Co., Ltd.
Customer Service Hotline: 020-31520790
24-Hour Consultation: 18126831382
Official Website: weitaigd.com
This article is for industry observation only and does not constitute legal advice. The regulatory provisions cited in this article are all from official public channels (National Healthcare Security Administration, Supreme People's Court, National Health Commission, National Medical Products Administration, Central Commission for Discipline Inspection and National Supervisory Commission, etc.). For specific legal application issues, please consult a professional lawyer.
