The CFDA is putting greater emphasis on the quality system management and post-market compliance of overseas medical device manufacturers. In the past, very rarely did the national CFDA make public announcements about suspensions of imported medical devices by mentioning a specific manufacturer’s name. Recently, the CFDA announced the overseas on-site inspection results of 9 manufacturers. The significant issues disclosed by the CFDA during the overseas inspections include internal packaging breakage, incomplete supplier information, improper handling of adverse events, airborne dust particles exceeding the standard, deficiencies in disinfection effect verification, raw materials mixing, testing standards mismanagement, lack of operating procedures, air filter supplier audits, etc.
To standardize the CFDA’s overseas inspection procedure, on December 28, 2017, CFDA issued a draft guideline for overseas inspection for comments. This guideline applies to overseas manufacturers who are marketing or intended to market their medical devices in China.
Here are some of the key points of this draft regulation:
- The overseas inspection is conducted by the Center for Food and Drug Inspection of CFDA.
- The CFDA shall disclose the basic status and results of the inspection.
Before the Inspection
- For each inspection, the CFDA will create a plan and disclose the basic information of the plan.
- The inspection purposes could be for risk analysis or a random inspection.
- Overseas manufacturers will be notified by the CFDA about the inspection. Manufacturers need to, within 20 business days of the notice, submit the Medical Device Overseas Inspection Basic Information Table to the center; and, within 40 business days of the notice, submit site master file and other required information as required by the Content of Site Master File.
- The CFDA, after receiving the Medical Device Oversea Inspection Basic Information Table, shall schedule the inspection and inform the manufacturers about the schedule. Manufacturers have 10 business days to submit a written request to postpone the inspection.
- There shall be at least 2 inspectors for each inspection and the working language during the inspection is to be Mandarin.
During the Inspection
- The center will issue an inspection plan. The inspection team shall follow the plan. Changes of the plan need the center’s approval.
- The inspection team shall host a startup meeting to inform the overseas manufacturer of the team composition, inspection purpose and scope, and inspection schedule.
- The overseas manufacturer shall provide all necessary documents, records, and data.
- According to the inspection needs, the inspection team may take the copy, the photograph, the camera, and so on collect evidence data.
- If a sample needs to be taken during the inspection, the inspection team shall sample, seal and attach sampling documents in accordance with the procedure.
- The inspection team shall host a final meeting for feedback about the inspection to the overseas manufacturer.
- The inspection team shall complete the inspection report within a specified time frame.
After the Inspection
- The inspection center shall provide feedback, in writing, per the Medical Device Overseas Inspection Deficiency guidelines to manufacturers within 40 business days after the inspection.
- Manufacturers shall, within 40 business days of receiving inspection feedback, shall submit the corrective outcome to the center. If the manufacturer could not provide the corrective outcome within the time frame, the manufacturer shall submit a detailed corrective progress, plan, and updates over time.
- The inspection center shall send a comprehensive evaluation report to the manufacturer within 40 business days of the receipt of corrective outcomes.
- The conclusion of the comprehensive evaluation can be “meets the requirements”, “meets the requirements after rectification”, and “does not meet the requirements”.