What Qualifications Are Required to Export Class II Medical Devices?

Direct answer: For the export of Class II medical devices, the domestic manufacturer must first obtain a Class II Medical Device Registration Certificate issued by the provincial drug regulatory authority and complete production licensing or filing in accordance with the Regulation on the Supervision and Administration of Medical Devices (State Council Order No. 739). At the export stage, the manufacturer must apply for a Medical Device Export Sales Certificate. The target market must also complete registration under local regulations; overseas certificates cannot replace local marketing authorization.

This FAQ was compiled by the Ameli Regulatory Editorial Team based on public pages of target-country regulatory authorities; the verification date is provided at the end.

Key requirements

• Competent authority: National Medical Products Administration (NMPA) — https://www.nmpa.gov.cn/ (Class II medical devices are registered by provincial drug regulatory departments).
• Applicable products: Class II medical devices (moderate risk, requiring strict control and management).
• Core documents: (1) Class II Medical Device Registration Certificate; (2) Production License or Production Filing Certificate; (3) Medical Device Export Sales Certificate; (4) ISO 13485 quality management system certificate (where required by the target market); (5) product technical documents; (6) declaration of conformity; (7) labels and instructions for use; (8) reference-country approval or free sales certificate (depending on the target market).
• Certificate validity: The Medical Device Registration Certificate is valid for 5 years (the Export Sales Certificate is processed under the current provisions on the administration of the Medical Device Export Sales Certificate).
• Local representative: There is no “local representative” concept at the domestic export stage; most target markets (e.g., Saudi Arabia, Brazil, Malaysia) legally require a local authorized representative.

Professional notes

• Regulation on the Supervision and Administration of Medical Devices (State Council Order No. 739, effective 1 June 2021) — https://www.gov.cn/zhengce/content/2021-03/18/content_5593739.htm
• Provisions on the Administration of the Medical Device Export Sales Certificate (NMPA Announcement No. 126 of 2025, effective 1 May 2026) — https://www.gov.cn/gongbao/2026/issue_12626/202603/content_7063188.html
• Measures for the Administration of Medical Device Registration and Filing (State Administration for Market Regulation Order No. 47)

Verification date: 30 October 2026.

Frequently asked questions

Are the export qualification requirements the same for Class II and Class III devices?

No. Class II devices are registered by the provincial drug regulatory authority, while Class III devices are registered by the national drug regulatory authority; the level of registration authority differs. The process for obtaining the Export Sales Certificate is the same.

Is a production license still required if the manufacturer only exports?

Yes. Manufacturing medical devices requires a Production License or production filing (contract manufacturing is handled under the contract manufacturing provisions), regardless of whether the products are sold domestically.

Can the Export Sales Certificate replace target-market registration?

No. It is only a document certifying that the product has been lawfully marketed in China or may be exported. The target market must still complete local registration under its own regulations.

Can a Class II product be exported without a registration certificate?

No. A medical device manufactured and sold in China must first obtain a registration certificate before applying for the Export Sales Certificate.

How Ameli can support

Ameli can help manufacturers identify the documents, validity periods and renewal milestones associated with Class II registration, production licensing and the Export Sales Certificate, and can prepare a target-market registration gap list for markets such as Saudi Arabia, Brazil and Malaysia.

Limitations: Ameli is not a CRO or agent. Ameli does not issue registration certificates, does not act as an agent before drug regulatory authorities, does not issue any official certificates, does not replace a target-market local representative, and does not provide legal advice.

Verification date: 30 October 2026 | Compiled by Ameli. The facts on this page are based on official sources; where figures are not publicly disclosed, they are marked “not publicly disclosed by the official source.”