MDSAP, 21 CFR 820, China GMP
Anyone who wants to be successful internationally, must not only know the differences but should also be able to employ all these systems.
Medical Device Single Audit Program - MDSAP
The MDSAP program tries to accommodate manufacturers and combines the different requirements for a QM System in the following countries
You want to re-approve your product in the USA. Is an MDSAP certificate sufficient to prove the QSR requirements of 21 CFR part 820?
The FDA accepts MDSAP audit reports as a replacement for routine inspections by the authority. The FDA's initial audit does not replace the MDSAP.
However, it is different for the USA's direct neighbor in Canada. In 2019, Canada became the first member of the MDSAP program. This means that to enter the Canadian market for Class II to IV products, you need an MDSAP certified Quality Management System.
The MDSAP is there to standardize and thus minimize your efforts. Does your company still have to fulfill the country-specific requirements from for example Brazil, even if you are not selling your Medical Device there? And when is it worthwhile to implement MDSAP? In collaboration with you and your company, we will assess if an introduction is worthwhile and demonstrate how to integrate the new requirements in the best possible way. In this way, you too can profit from the advantages of this program.
In addition to the official MDSAP observers (currently the World Health Organization - WHO and the European Union), there are now two "Affiliate Members":
- Argentinians National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Koreas Ministry of Food and Drug Safety
The new group of affiliate members would like to participate in the MDSAP and use the audits and reports to assess the Quality Management of the manufacturers. However, the MDSAP requirements such as the Audit Model or the Companion Document are not supplemented by the requirements of the Affiliate Members.
Good manufacturing practice – China GMP, KGMP, cGMP
GMP is understood to be "Good Manufacturing Practice". The term is universally used in the pharmaceutical industry, and the requirements for Quality Management are often summarized under this abbreviation for Medical Devices. The objectives, requirements, and standards of GMP are similar, but each industry and country has specific requirements and differences. For example, the China GMP, Korean GMP or the current GMP (cGMP) of the US FDA.
Have you already implemented a work instruction for pest control in your company as required by KGMP ("Korean GMP")?
qtec as your partner
If you want to conquer a new market, there is no way around the diverse and additional requirements for your QM System.
We are aware of the differences between the GMP in China and South Korea and will prepare you for mastering the Asian Medical Device market with minimal effort.
Our audits and QM System experts know how you can implement new processes without creating chaotic work environments or file corpses.