Drugdu.com expert's response:

 

To apply for a Medical Device Manufacturing License, enterprises need to follow a systematic process that covers material preparation, review stages, and key compliance points, as outlined below:

Pre-Application Core Condition Self-Check

Qualification Foundations

Medical Device Registration: Possession of a valid Medical Device Registration Certificate and product technical requirement documents for the intended medical device production.

Business License Scope: The business license must explicitly include medical device manufacturing within its scope of operations.

Production Conditions

Facilities: Adequate production facilities matching the scale of operations, including cleanrooms (compliant with ISO 14644 standards for sterile medical devices) and storage areas. Provide property ownership certificates or lease agreements.

Equipment: Equipped with primary production equipment (e.g., injection molding machines, sterilization equipment) and inspection instruments (e.g., microbiological testers, mechanical testers). A detailed equipment list should be provided.

Personnel:

Production, quality, and technical leaders must possess relevant professional qualifications (e.g., degrees in biomedical engineering, pharmacy) or professional titles (e.g., intermediate engineer). The quality leader must not concurrently serve as the production leader.

Key personnel (e.g., inspectors) must undergo professional training and hold valid certification.

Quality Management System

Establish a quality manual, procedural documents, and work instructions compliant with ISO 13485 standards, covering the entire lifecycle from design and development to procurement, production, and inspection.

Develop risk management documentation to identify and control risks throughout the product lifecycle (e.g., biocompatibility, electrical safety).

Application Material Checklist

Basic Documents

Application Form: Completed Medical Device Manufacturing License Application Form (signed by the legal representative and stamped with the official seal).

Business License Copy: A copy of the business license.

Identity Documents: Copies of identity documents and appointment letters for the legal representative and enterprise leader.

Product and Personnel Documentation

Medical Device Registration: Copies of the Medical Device Registration Certificate and product technical requirements.

Personnel Qualifications: Educational/professional title certificates and resumes for production, quality, and technical leaders.

Training Records: Training records for key personnel (e.g., internal auditor certificates, inspector qualifications).

Production and Quality Documentation

Facility Layout: Production site floor plan (including cleanroom layout) and environmental testing reports (e.g., particle count, settle plate tests).

Equipment List: A list of primary production and inspection equipment (specifying model, quantity, and purpose).

Quality Management Documentation: Quality management system documents (including procedural documents and record templates).

Process Flowcharts: Process flowcharts and descriptions of key processes (e.g., sterilization parameters, assembly steps).

Additional Materials

Product Testing Reports: Self-inspection or commissioned testing reports (issued by CMA/CNAS-accredited institutions).

After-Sales Service Proof: Evidence of after-sales service capabilities (e.g., service network distribution, customer service team configuration).

Self-Inspection Form: A manufacturer self-inspection form covering 12 aspects, including personnel, equipment, and documentation.

Application Process Details

Submission

Download the application form from the official website of the provincial药品监督管理局 (Provincial Drug Regulatory Authority) and submit it along with two copies of the paper materials to the administrative acceptance window of the provincial regulatory authority.

Formal Review

The regulatory authority completes a material completeness review within 5 working days. If materials are incomplete or non-compliant, a one-time notification for supplementary materials will be issued (e.g., missing testing reports, unclear facility proofs).

On-Site Inspection

Upon passing the formal review, an inspection team conducts an on-site inspection, focusing on:

Consistency of production facilities with declared information and cleanroom environmental compliance.

Proper functioning of equipment and calibration of inspection instruments.

Effective operation of the quality management system (e.g., completeness of documentation records, operability of traceability systems).

Product Testing

Random sampling and testing of declared products for performance indicators and safety requirements (e.g., electrical safety, bioburden testing).

Approval and Issuance

Based on material review, on-site inspection, and testing results, the regulatory authority makes an approval decision within 20 working days.

Approved applicants are issued a Medical Device Manufacturing License valid for 5 years, specifying the production scope (e.g., "Class III: 6846 Implantable Materials and Artificial Organs").

Key Compliance Points

Classification Management

Class I medical devices are subject to filing procedures only and do not require a manufacturing license. Class II and Class III devices require a license, with stricter reviews for Class III devices (e.g., implantable devices).

UDI Implementation

Products must be labeled with a Unique Device Identification (UDI), comprising a Device Identifier (DI) and Production Identifier (PI), and uploaded to the National Medical Products Administration's UDI database.

Change Management

Any changes to production address, product scope, etc., must be reported to the original issuing authority within 30 days of the change. Failure to do so may result in penalties.

Renewal Application

A renewal application must be submitted 6 months prior to license expiration. The regulatory authority may conduct an on-site re-inspection. Failure to apply on time requires reapplication.

Example: Key Points for Sterile Medical Device Applications

Facility Requirements: Cleanrooms must meet Class 10,000 standards (with Class 100 local areas). Provide environmental testing reports (e.g., particle count ≤ 3.5×10³/m³).

Sterilization Validation: Submit sterilization process validation reports (e.g., ethylene oxide residual testing for EO sterilization).

Package Integrity: Provide sterile packaging integrity testing reports (e.g., dye penetration tests, vacuum decay tests).

By systematically preparing materials, rigorously self-checking production conditions, and cooperating with regulatory reviews, enterprises can efficiently complete the license application process, ensure compliant production, and enhance market competitiveness.

 

By editor