Will ANVISA’s acceptance of ISO13485 certification be the end of MDSAP?

October 2017 ANVISA, the Brazilian regulatory authority, published resolution RDC no. 183 stating that for medical device manufacturers located outside the Brazilian territory and Mercosur, a different approach regarding granting of Good Manufacturing Practices (GMP) will be taken.

The decision about whether or not to do an onsite inspection before granting the Brazilian GMP (BGMP) certificate, will still depend on ANVISA's assessment of the submitted documents and certificates, but at least the Brazilian authorities now offer various routes that may result in the BGMP certificate without the onsite inspection. 

You might wonder if this RDC no. 183 is referring to the Medical Device Single Audit Program (MDSAP) where ANVISA is one of the participating partners. Yes, it does refer to the acceptance of the MDSAP, but additional routes are offered and one of them accepts the use of the ISO13485 certificate as the basis for the assessment. 
 
The RDC no. 183 only talks about the mandatory Brazilian GMP for manufacturers of Class III and IV medical devices as for the so-called ‘cadastro’ route, the Brazilian GMP certificate is not required.

So, what does this new resolution mean for the value of the MDSAP? So far, our experience is mainly that medical device manufacturers of high-risk devices or larger corporations that market their devices in the US, Brazil, Canada, Australia and Japan see the MDSAP as a more efficient and less expensive alternative to separated audits. But, many small and medium-sized companies see the MDSAP route as a significant and not necessarily favorable increase in cost and effort. The discussion about MDSAP is mainly driven by the deadline set by Health Canada, no longer accepting any other GMP-certificate from the 1st of January 2019. So, those companies are weighing the importance of the Canadian market for their portfolio. Probably, as Canada for many manufacturers is not one of the main markets, the result will be that several will withdraw their medical devices from the Canadian market. 

But apart from Canada, MDSAP is still interesting if you market your high-risk devices in Brazil as this market was considered difficult to enter due to the mandatory BGMP certificate and the enormous delay of ANVISA in planning and executing the related onsite inspections. Actions to shorten or avoid this delay have been taken by medical device manufacturers, by grouping together (ABIMED) or by using an experienced lawyer demanding ANVISA to meet the official inspection deadlines. Good options, but still with restrictions as using the ABIMED-route you are able to register your medical device, but will not include the B-GMP certificate, meaning ANVISA can still come and audit you after your device is already in the market, so no guarantee to success. Using a lawyer will increase the budget needed for the registration, but is seen as the best alternative with a positive effect on the timelines. 
 
MDSAP looked like the perfect alternative, as the capacity problems at ANVISA can be avoided and you will have your Brazilian GMP certificate based on the MDSAP audit report. A very good reason to choose the MDSAP if Brazil is one of your main markets.

Though MDSAP is still a possible route to the BGMP certificate, this recently published RDC no. 183 may offer even better alternatives to obtain this valuable BGMP Certificate. 

Let’s look at all the possibilities that are mentioned in the resolution. 

In the resolution RDC no. 183 is stated that for medical devices of risk classes III and IV there are several routes available that may lead to issuing the Brazilian GMP certificate without the need of an onsite inspection by ANVISA.  
 
For establishments that participate in the MDSAP, the Brazilian GMP certificate will be granted after pre-evaluation of the auditing report presented based on the guidelines established by the program.

With specific countries, there are mutual recognition agreements or covenants. Based on the guidelines and requirements as established within the scope of each agreement or covenant, use of confidential information related to previous inspections may result in the grant of the Brazilian GMP certificate. 

Most interesting for many medical device manufacturers is the route where the evaluation of the inspection or auditing report issued by a Health Authority that is IMDRF-member or by a third-party auditing organization recognized by that Health Authority may result in the grant of the B-GMP certificate. Current IMDRF-members are Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea and the United States of America. 

This route does require an inspection or audit report that has been issued in until 2 (two) years before you apply for BGMP by submitting the required documents to ANVISA, and must include the risk classes of and production lines of the devices that are subject to the certification request.

The last route offered is when you do not possess any of the above auditing reports. In this case, ANVISA will do a risk analysis of your documentation and decide the need of in loco inspection before granting the BGMP certificate.

Based on the above we think all high-risk class medical device manufacturers will see new opportunities thanks to this RDC no. 183 and we believe that for companies with a good history of audit reports, deadlines will at least be shorter and in the best-case scenario, manufacturers are exempted from onsite inspection by ANVISA based on a successful ISO13485 audit or a successful FDA QSR inspection report.

Any questions about Brazil regulation or MDSAP, just let us know.

Sheila Jaime
Laura Koekenberg
Post date: February 15, 2018
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