Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. These are some MDSAP FAQ  that might help you with your doubts.

• We sell in Canada. Is MDSAP required?

Yes, you’ll need a MDSAP if you want to sell any Class II, class III, or class IV devices in Canada. If you sell only Class I devices, you do not need MDSAP certification.

• We only sell in the US and Europe. Do we need MDSAP

No. Europe is not a participant in the MDSAP program and the US FDA does not require participation at this time, so it would not make any sense to get MDSAP certified unless you knew for certain that you plan to expand sales into Canada, Brazil, Japan, or Australia. Even then, you will need to weigh the costs of compliance with MDSAP against your sales potential in those markets. Canada is the only market that requires MDSAP certification.

• What language will be used for the MDSAP audit reports?

Per MDSAP AU P0019.004, section 2.2 Report Language: “The language of the report is subject to the operating language of the auditing organization and should be understandable by the manufacturer; however, all audit reports must also be available in English.” The manufacturer should clarify this with their AO along with any other report needs 

• Is the MDSAP Stage 1 Documentation Review part of the audit time calculation?

The Stage 1 Documentation Review is not part of the audit time calculation. Per MDSAP P0008.006 Audit Time Determination Procedure, for initial certification audits the auditor will calculate the duration of Stage 2 using the assigned minutes per task in MDSAP P0008 and then “add 25%. The result will reflect the duration of audit (i.e., time necessary to perform Stage 1 and Stage 2.” The AO may combine elements of Stage 1 and Stage 2 to allow for a single on-site visit to the manufacturer.

Read More - Medical Device Single Audit Program (MDSAP)

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

5.How to start the Manufacturing of Disposable Syringes

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

Are you preparing for the Medical Device Single Audit Program (MDSAP) audit process?

The International Medical Device Regulators Forum (IMDRF) perceives that a worldwide way to deal with examining and checking the manufacturing of medical devices could improve their security and oversight on a global scale. At its debut meeting in Singapore in 2012, the IMDRF recognized a work gathering to create explicit reports for propelling a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program permits an MDSAP perceived Auditing Organization to lead a single regulatory audit of a medical device maker that fulfils the pertinent necessities of the regulatory authorities taking an interest in the program.

International partners that are taking an interest in the MDSAP include:

• TGA -Therapeutic Goods Administration of Australia
• ANVISA -Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada – Canada
• MHLW – Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• FDA – USA
• The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers

The audit of MDSAP depends on 13485:2016 with the appropriate regulatory necessity of the interested authority – Australia, Canada, Japan, Brazil, USA – included as regions of core interest. The MDSAP Companion Document distinguishes the audit work that must be secured and the connections to the appropriate regulatory prerequisites for interested authority. The guidance material for MDSAP audits is accessible on the US FDA site under CDRH Learn (go to Quality Systems – Inspections – Global Harmonization). MDSAP reports are likewise openly accessible to all.

The new annexes are titled as follows:

• Audit of Product/Process related Technologies and Technical Documentation
• Audit of Requirements for Sterile Medical Devices
• Medical Device Adverse Events and Advisory Notices Reporting Process Quick Reference
• Requirements for Written Agreements
• Medical Device Single Audit Program background and current adoption status

There should be a focus on a productive report on updating and sharing for the ones if your organization is over various locations. (In this case where a medical device certain QMS software can truly help). The emphasis will be on your essential site, which is the place most of the audit will be held. This is any way of which procedures are off-site and incorporates virtual manufacturers. The actual audits will start with the management audit. This incorporates your management audit, processes, quality manual and approach, record control, marketing clearances and licenses. Examiners are keen on comparable things which are incorporated into FDA inspections or ISO audits.

Read More -  Medical Device Single Audit Program

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device