China Pharmaceutical and Medical Device Regulation: Market Access and Compliance for Foreign Companies

The following is general information on Chinese pharmaceutical and medical device regulation, not legal advice for any specific product or matter. Regulatory pathways and requirements change, and product-specific decisions depend on the facts; consult qualified counsel before acting.

The licensing ladder: drugs, devices and cosmetics

China regulates healthcare products through three principal statutes. The Drug Administration Law (药品管理法) was adopted on 26 August 2019 and took effect on 1 December 2019, and it introduced the marketing authorisation holder system described below. Medical devices are governed by the Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例), revised as State Council Order No. 739, signed on 9 February 2021 and effective 1 June 2021 — a three-class scheme in which Class I devices are subject to filing and Class II and III devices require registration with the National Medical Products Administration (NMPA) or its provincial counterparts. Cosmetics sit under the Regulations on the Supervision and Administration of Cosmetics (化妆品监督管理条例, Order No. 727), adopted 16 June 2020 and effective 1 January 2021. A foreign company's first question is therefore not a single China approval but which ladder its product is on.

The Marketing Authorisation Holder system

The 2019 Drug Administration Law replaced the old licence-per-site model with the marketing authorisation holder (MAH) system (药品上市许可持有人). Article 6 makes the MAH responsible for the quality, safety and efficacy of the drug for its entire life cycle; Article 30 lists the MAH's core obligations — quality management, pharmacovigilance, recall, and liability for harm; and Article 38 requires an overseas MAH to designate a domestic enterprise (境内企业法人) to perform its obligations in China and bear joint liability. The MAH can hold the registration without owning the manufacturing facility, which opened the door to licence-holding and contract-manufacturing arrangements that did not exist before.

Market entry paths for foreign manufacturers

The practical routes for a foreign drug are registration and clinical trial. A drug must obtain a drug registration certificate (药品注册证书) before marketing, under Article 24 of the 2019 law; applications go through the NMPA's Centre for Drug Evaluation. Clinical trials run on an implied-approval mechanism: under Article 19, if the regulator raises no objection within 60 working days, the trial may proceed. For devices, Class I is a filing, while Class II and III — and imported devices — go through registration with technical documentation and, for higher-risk devices, clinical evaluation. The realistic timeline and the dossier requirements differ sharply by product, which is why the classification question comes first.

Post-market obligations and liability

Approval is the beginning, not the end. The MAH must run pharmacovigilance, report adverse events, and recall product when needed; for medical devices, the same post-market surveillance and adverse-event reporting obligations apply under the 2021 regulation. On liability, the Drug Administration Law imposes a punitive-damages regime for harm caused by defective drugs, and product liability claims run in parallel under the Civil Code. A foreign manufacturer that enters through a domestic MAH or a distributor should fix in writing who holds the registration, who runs pharmacovigilance, who responds to the regulator, and who bears the liability — because under Article 38 the designated domestic entity is jointly liable with the overseas holder.

Practical steps for a foreign company

• Classify first. Is the product a drug, a device (and which class), or a cosmetic? The classification determines the entire pathway.
• Decide the holder. Register directly as a foreign MAH with a designated domestic entity, or partner with a domestic MAH.
• Plan clinical evidence early. The 60-working-day implied-approval clock for drug trials does not shorten the trial itself.
• Budget post-market compliance. Pharmacovigilance, adverse-event reporting and recall are statutory, not optional.
• Document the liability split with any partner, and confirm the joint-liability rule under Article 38.

The regulatory frame is current as of the date of writing and applied on the facts of each product; the summary above is general information, and specific article numbers should be confirmed against the official text. For product-harm claims that follow a defective drug or device, see our guide to product liability in China for foreign companies, and for the recall and crisis-response mechanics, see China product recall: crisis response for foreign companies.