These days, we have experienced flight inspections, supervised spot inspections, and on-site inspections, but do you know their new members "unannounced visits"? Is to wait for the punishment to the head, just suddenly realized that this can be investigated in this way! I think it's important for you to know in advance:

On April 19, 2019, Hubei Bureau issued the "Provincial Bureau to carry out a secret Visit to the Province's Drug Safety Investigation", announcing that it had sent five secret visit teams to investigate the prominent problems and weak links in the supervision of drugs, medical devices and cosmetics. The secret visit is completely different from the common supervision and inspection methods, with no notice in advance, no greeting, no listening to reports, no accompanying reception, going straight to the grassroots, directly inserted into the scene, inspecting enterprises, randomly checking medical service institutions, and grassroots regulatory agencies.

Medical device unannounced visit was born, how should enterprises accept the move? (Figure 1)

A stepped-up regulatory approach

With the strengthening of post-market supervision, compliance workers are facing increasing pressure. On the other hand, regulatory information is gradually open and transparent, so that we can clearly understand what the focus of the "inspection" of the regulatory authorities is, and what problems have been found in similar enterprises?

To this end, Compliance Treasure has launched a series of supervision and inspection databases for all VIP members, including: overseas medical device on-site inspection (40+), operating enterprise flight inspection (30+), production enterprise flight inspection (120+), and user unit flight inspection 4 modules. At present, the on-site inspection of overseas medical devices has met with everyone, and VIP members can directly click to view!

Medical device unannounced visit was born, how should enterprises accept the move? (Figure 2)

It can be searched by inspection varieties, production sites, inspection types, etc. We will show you the agent, inspection basis, registrant, inspection results, inspection details, etc.

Medical device unannounced visit was born, how should enterprises accept the move? (Figure 3)

Medical device unannounced visit was born, how should enterprises accept the move? (Figure 4)

Medical device unannounced visit was born, how should enterprises accept the move? (Figure 1)

Existing supervision and inspection basis

Open the Compliance page, search and check the relevant regulations, a total of 16, including:

Measures for Flight Inspection of Drugs and Medical Devices

Announcement on the Release of Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices

Notice of the Food and Drug Administration on Issuing Regulations on the Administration of Medical Device Quality Supervision and Sampling Inspection

Notice of the Food and Drug Administration on Issuing Guidelines for On-site Inspection of Medical Device Management Quality Management Practices

Notice of the General Office of the Food and Drug Administration on Issuing Guidelines for the Daily Supervision and On-site Inspection of Medical Device Production

It can be seen that there are no relevant regulations on covert visits, will it be introduced in the near future?

Medical device unannounced visit was born, how should enterprises accept the move? (Figure 1)

Specific implementation methods of unannounced visits

The Hubei Bureau has not yet announced the specific methods of unannounced visits. According to the related plans of unannounced visits to drugs published by other provinces, unannounced inspections are mostly carried out by field investigations, clandestine visits, interviews, sampling tests, etc., through audio and video recordings, telephone consultations, simulated services and other means.

The contents of the hidden investigation such as the investigation of GSP freight, consistency, whether there is a link in the drug business, ticket, check the situation of drug purchase, whether licensed pharmacists are equipped in accordance with the regulations, whether licensed pharmacists are on the job, whether drugs are purchased from legal channels, and so on.

The most important thing is that the unannounced investigation will focus on objects with high attention, complaints and reports, daily management confusion, high risk levels, and great social impact, and increase random checks.