Anvisa Issues RDC No. 850
Anvisa has issued RDC No. 850, amending the previous RDC No. 497 of 2021, with key implications for companies operating in the medical device sector. Here are the main changes and their impacts:
Extended Validity
One of the primary amendments introduced by RDC No. 850 is the extension of the validity period for Good Manufacturing Practices Certification for medical device manufacturers from 2 to 4 years. However, this extension is contingent upon the continued participation of companies in the Medical Device Single Audit Program (MDSAP) throughout the certification term.
Impact on Pending Applications
The resolution also stipulates that certification petitions and renewals submitted before its enactment, but whose decisions have not been finalized, will automatically align with the new four-year validity period.
By prolonging the validity of Good Practice Certification to four years, subject to ongoing adherence to MDSAP, Anvisa not only underscores the significance of consistently robust manufacturing and distribution processes but also incentivizes companies to uphold high regulatory standards.
Companies enrolled in the Medical Device Single Audit Program (MDSAP) should conduct thorough reviews of their compliance and certification procedures to ensure readiness for these modifications. This includes maintaining active engagement in MDSAP and strategizing for certification renewals in light of the extended validity period.
RDC No. 850 will be effective starting April 1, 2024, allowing ample time for affected companies to adapt to the updated requirements.
It's essential to note that for companies not participating in MDSAP, the validity of the Certificate of Good Manufacturing Practices for medical devices remains unchanged at 2 years.
Regulatory Impact
- Top Priority: No
- Type Certificate: Yes
- Spectrum Bands: No
- Import Changes HS Codes: No
- Standard Changes: Yes
- Product Changes: No
- Label Changes: No
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |