Drugdu.com expert's response:

The primary condition for the registration of imported medical devices is that the product must have been approved for marketing and sales in the country (or region) where the applicant or filer is registered or where the manufacturing address is located. This condition serves as the foundation for ensuring the legality and safety of imported medical devices, and can be understood from the following aspects:

Legal Basis

Article 13 of the Medical Device Registration Regulations (Order No. 4 of the CFDA) explicitly stipulates that imported medical devices applying for registration or filing must have been approved for marketing and sales in the country (or region) where the applicant or filer is registered or where the manufacturing address is located.

The Regulations on the Supervision and Administration of Medical Devices also emphasize the requirement for imported medical devices to have been marketed abroad, ensuring compliance with international or local medical device regulatory standards.

Specific Requirements

Marketing Approval Documents: Imported medical devices must provide documents issued by the medical device regulatory authority in the country (or region) of registration or manufacturing address, granting approval for the product to be marketed and sold. These documents are crucial evidence of the product's legality and safety.

Corporate Qualification Documents: Overseas applicants must also provide corporate qualification documents, such as those issued by the company registration authority or medical device regulatory authority, proving the existence of the overseas applicant and its qualification to manufacture the corresponding medical devices.

Special Circumstances Handling: If a product is not classified as a medical device abroad but is classified as such in China, documents proving that it is not a medical device abroad, as well as relevant documents granting approval for marketing and sales in the country of origin, must be provided.

Practical Considerations in Operation

Agent System: Overseas applicants or filers should designate a representative office established in China or appoint a corporate legal person within China as an agent to cooperate in relevant work. The agent must possess medical device business qualifications and assume legal responsibilities for post-market adverse event monitoring of the product.

Language Compliance: The instructions and labels of imported medical devices must undergo professional translation certified by a notary office and comply with Chinese language norms. For example, there are strict regulations on the font height of Chinese labels; the font height of the product name on the main display surface should be no less than 4mm, and the font height of the registration certificate number should be no less than 2mm.

Technical Documentation Requirements: Imported medical devices must submit quality management system certification documents that comply with the ISO 13485 standard, and the certification body must be recognized by the China National Accreditation Service for Conformity Assessment (CNCA). Additionally, when accepting overseas clinical trial data, an analysis of applicability to the Chinese population must be submitted.