It’s a small world after all… but with big differences in regulation

Let’s have a look at the mid-size European medical device manufacturer, that has just successfully obtained its EC certificate and is ready to concur new markets – USA, Canada, Brazil, China, South Korea, and so on. The QMS system is typically certified in accordance with ISO 13485 standard and it seems like there should not be any other obstacles on the registration pathway.

Nearly every jurisdiction around the world has a formalized registration process that medical device manufacturers must follow to legally sell a product into markets. Some of them may differ slightly from the next. Not only do manufacturers need to register their device(s) initially, but they may need to renew their registration on a recurring, annual basis and support the device post-market. Leveraging an industry-specific Quality Management System (QMS), which is built to enable those processes, is key.

In section 4.1.4., “The organization shall manage the quality management system processes in accordance with [...] applicable regulatory requirements”. In section 4.2.1, “The quality management system documentation shall include […]other documentation specified by applicable regulatory requirements. Again in section 7.2.3, “The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements”.

At the end of the day, one of the main purposes of the QMS is to bring together regulatory requirements from a variety of jurisdictions into a single systematic approach that allows the organization to conform to these differentiating requirements. And this is not only about successful device registration.

QMS requirements are different in terms of post-marketing, vigilance reporting, labeling, UDI requirements, and many more other sub-systems. Let’s look at the several examples:

The more countries the manufacturer is targeting, the more the fulfillment of having a QMS compliant with applicable regulations becomes difficult. This is the reason why several countries have initiated the Medical Device Single Audit Program (MDSAP) which was designed and developed to allow a single audit of a medical device manufacturer to be applied to all jurisdictions whose regulatory authorities are members of the program. At the moment, it includes 5 countries (Australia, Brazil, Canada, Japan, and the USA), some major markets are not present yet such as the EU, China, South Korea, and the United Kingdom. And it may be difficult for companies to ensure and have proofs that their QMS is compliant. That could cause a problem if one of the local authorities performs an inspection and detects noncompliance within a “certified” QMS.

In practice, organizations’ internal auditors are struggling with the preparation and conduction of an extensive internal audit mainly due to the lack of in-depth knowledge and understanding of the additional country-specific regulatory QMS requirements. With a focus on helping manufacturers in preparation for the upcoming MDSAP inspections as well as internal QMS audits dedicated to verifying compliance with several other jurisdiction regulatory requirements Qserve has introduced an MDSAP++ (MOCK) audit service. This type of mock audit is performed in accordance with the MDSAP guidelines and thus allow to assess the organization’s QMS compliance with the requirements of five participating Regulatory Authorities (RA) from the official MDSAP program, and the QMS requirements of for instance China, South Korea, Taiwan, and the United Kingdom.

Qserve plans to add the requirements of current MDSAP Affiliate Members: Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT), and Singapore’s Health Sciences Authority (HSA) since they are interested in engaging in the MDSAP program and can be included in the nearest future. At this moment, 3 Affiliate Members (including the Republic of Korea’s Ministry of Food and Drug Safety) are subject to certain rules. They are only given access to a certain level of information about the manufacturers, audit dates, and information in audit reports. They are also invited to attend sessions that are open to members, observers (such as EU, MHRA, WHO), and affiliates only.

The newly developed MDSAP++ (MOCK) audit service is beneficial for manufacturers in the following aspects:

• The additional country-specific QMS requirements are addressed along with the relevant MDSAP chapters and serve as an integral part of the MDSAP (MOCK) audit.
• It is more effective to audit the QMS against those requirements all in conjunction than audit each country specifically and separately. This approach will also help the manufacturer to better identify the overlaps, similarities, and differences between various jurisdictions.
• The manufacturer has an opportunity to take appropriate corrective actions before an actual MDSAP inspection or regular QMS audit concerning all jurisdictions in the scope of QMS.