not haveOn the operation of Class II devices (such as thermometers, sphygmomanometers) or Class III devices (such as cardiac stents, artificial joints), are required to have a medical device filing license. This article combines the latest policy of Beijing 2026 March, combing the filing classification, processing procedures, materials list, avoiding the pit guide, and policy dividends and processing methods comparison, to help you efficiently get a license, less detour, novice can also easily get started!

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01.First distinguish: two types VS three types, filing and licensing are very different

Medical devices are divided into three categories according to the risk level, in which Class II and Class III need to handle the relevant qualifications, the difference between the two requirements is significant, a table to see the core difference:

💡 Key reminders

The second category focuses on "material compliance" and can be processed online; the third category focuses on "actual operational capability" and must be verified on site, which is a higher threshold.

Beijing Medical Equipment Record Certificate

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02.Process: online + offline dual-channel, one step without stepping on pits

Whether two types of filing or three types of licenses, are unified in the "Beijing Municipal Drug Administration Enterprise Service Platform" online initiation, the process is clear and traceable, separated from the description of the more understandable:

(I) Class II medical device business filing (simple and easy to do, novice-friendly)

1. online applicationLogin to the official platform, enter the "medical device business start-up (for the record) application" module, fill in the "Class II Medical Device Business Record Form", upload the relevant materials (PDF format, clear and legible).
2. Formal review: Pharmacovigilance department to review the material within 5 working days, if the information is incomplete (such as the quality of the person in charge of the missing academic certificate), will be through the platform feedback to make up for the correction, timely supplement can be.
3. file for record and issue a certificate: After passing the audit, the "Class II Medical Device Business Record Certificate" will be issued within 10 working days, which can be downloaded electronically (with the same effect as the paper version), or collected on-site at the Government Service Center.

(ii) Class III medical device business license (more stringent process, focusing on on-site verification)

1. Online Declaration: The same official platform to submit the "Medical Device Business License Application Form", in addition to the basic materials, additional upload the product registration certificate (or authorization), cold chain transportation agreement (such as the operation of in vitro diagnostic reagents), warehouse floor plan and so on.
2. on-site verification: drug supervision department to send a commissioner door-to-door verification, focusing on checking three points: ① warehouse temperature and humidity control (need to be equipped with monitoring); ② sterile device storage conditions (three sterile devices need to be more than 200 square meters of independent storage); ③ quality management system operation records (procurement and acceptance ledger, records of non-conforming products processing, etc.).
3. examination and deposition: After the verification is passed, the "Medical Device Business License" will be issued within 20 working days, valid for 5 years, and need to be hung in a prominent position in the business premises.

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03. Bill of materials: one is missing! A must-see guide for newbies to avoid the pitfalls

Material preparation is the key to get a license, less one may be rejected, organized by category, directly against the preparation can be:

(i) Generic materials (required for both categories II and III)

• A copy of business license (the business scope should clearly include "medical equipment sales", without this scope needs to be changed);
• Legal representative, quality person in charge of ID card and proof of education / title (quality person in charge of college degree or above, medical devices, biomedical engineering and other related disciplines are preferred);
• Proof of property rights or lease contract for business premises and warehouse (remaining lease term ≥ 1 year, address should be consistent with business license, no false address);
• Enterprise organization chart (clarify the responsibilities of the person in charge of quality, not to be omitted).

(ii) Additional materials for Category II filings

• Quality management system document catalog (at least 12 systems including procurement, acceptance, storage, sales, after-sales, etc., can refer to the template of the drug regulatory department, no need to write their own);
• A description of the computerized information management system (if ERP is used to manage inventory, a brief description of the functional modules is sufficient and need not be elaborated in a complex manner).

(iii) Three types of additional materials for licenses

• Product registration certificate or overseas manufacturer's authorization (imported devices need to provide Chinese translation to ensure accurate translation);
• Proof of professional qualifications (e.g., one internal auditor's certificate is required for the operation of sterile devices, and inspector's qualification certificate is required for the operation of in vitro diagnostic reagents);
• Proof of cold chain transportation capability (e.g. temperature control agreement with third party logistics company, driving license of own refrigerated trucks, as required).

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04. High-frequency questions and answers: 90% people have stepped on the pit, to avoid is to win!

Q1: Do the business premises and the warehouse have to be at the same address?

Category II filing: can be separated, but the warehouse needs to be independent and in line with the storage conditions (e.g., cool warehouse, room temperature warehouse partition, avoid mixing);

Type III license: If operating sterile devices, the warehouse must be in the same building as the business premises to facilitate the supervision of the drug administration department.

Q2: Can the person responsible for quality hold other positions?

Can be, but need to be full-time on the job, and shall not be in other enterprises part-time quality management of medical devices, need to provide proof of payment of social security to support (to avoid "titular").

Q3: What else do I need to do after I get the filing/permit?

• The Annual Self-Study Report should be submitted through the official platform by January 31st of each year, and cannot be delayed;
• Changes in business address, personnel, and scope of business are required to apply for a change in filing/permit within 30 days to avoid violations;
• Acceptance of "flight inspection" (unannounced inspection without prior notice) by the Drug Administration, focusing on verification of product traceability, adverse event reporting records, need to be prepared in advance.

Model Medical Device License

05. Policy dividend: Beijing's "one business, one license" reform saves time and effort!

In 2026, Beijing implemented the "Efficiently Doing One Thing" service, whereby medical device companies can enjoy significant convenience by applying for multiple certificates simultaneously, without having to run multiple times and submit materials repeatedly:

• Streamlining of materials: Repetitive information (such as business license, personnel qualifications) is exempted from repeated submission, and the overall reduction of approval materials is 40%;
• One-window acceptance: Dongcheng District, Fengtai District, Haidian District and other government service centers, are equipped with "medical equipment integrated window", specialists to help guide, newcomers can also quickly get started;
• Time limit compression: multi-certificate parallel approval, the total time limit from the "single document cumulative" to "the longest document shall prevail", the fastest 15 working days to get the full license (such as at the same time to do the two types of filing + three types of licenses).

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06. Independent processing vs. professional agency: how to choose more cost-effective?

Many companies are torn between the two ways of processing, combining time, cost and risk, a table to help you decide:

Applicable Scenario Suggestion:① start-ups / inexperienced team: recommended to do it on behalf of the time and worry, to avoid delays in opening due to material errors; ② large groups / familiar with the process: can be handled independently to reduce costs, but need to set aside enough time to deal with corrections.

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Conclusion: Compliance starts with getting your license!

Medical device industry "high threshold, high return", but the qualification compliance is the bottom line. 2026 North Beijing drug supervision department to strengthen the "intelligent supervision", through the big data tracking product flow, personnel qualifications

📌Beijing company registration, tax compliance, difficult cancellation, qualification license, subsidy application, etc.Welcome to sweep the code to add our online customer service (micro letter: jxhqcy890 / cell phone: 16625410105), the arrangement of the manager to answer questions, provide professional advice and full one-on-one service!