Good Distribution Practices of Medical Devices by Swiss Approval International
GDPMD Certification – Good Distribution Practices of Medical Devices
Organizations that involved in manufacturing, wholesaling, distribution and importing Medical Devices required to implement a QMS and obtain GDPMD certificate applying for licence to their establishment through c Certification.
MD companies required to implement QMS which include procedures and provide suitable facilities and people to handle the medical devices.
Companies can use the resources on this website as well as the links to develop their GDPMD certification QMS or can employ GDP consultant to assist.
We can assistant for any query relevant to certification purpose and initial guidelines to achieve this certification.
GDPMD Certification that part of quality assurance which ensures that products consistently stored, transported and handled under suitable condition.
In order to provide such assurance, companies will require more than just a set of quality manuals, it requires a comprehensive system to “give assurance”.
GDPMD System to Compliance
This may include appropriate procedures, suitably trained and qualified personnel, correct processes and facilities.
Further more equipment as well as clear to credibly demonstrate the consistency of quality assurance.
Companies who currently certified to ISO 9001 will find that they have partially fulfilled the GDPMD requirements.
However; there are differences between ISO 9001 and GDPMD which companies will need to reconcile before going for the audit.
In addition; companies who have implemented similar QMS in other countries may not 100% compliant as the requirements are not identical.
Certification to GDPMD
Companies are encourage to prepare early and be ready to apply for their licence before the mandatory deadline to avoid a last minute panic and potential business interruption.
Companies who have not implemented a system which complies with the GDPMD requirements will need time to implement the system.
Generate records through the normal business process and test out their systems.
Steps to Apply for Certification
How to Apply
- Inquiry: Submit the inquiry form with detail of organization as per required questions in the form.
The correct information shall enable us to provide the cost effective and competitive proposal of certification of three years.
- Proposal: Estimated cost of services is provided for contract.
- Contract: A contract is issued to initiate the certification services accordingly in which organization is provided three years certification terms of references.
Organization inform SAI to conduct audit as per mutual understanding and readiness of system.
- Audit & Certificate: Audit is performed at client location and reference to the observation and issues closing certificate against successful achievement of requirements as a result;
Certificate issued to organization to maintain the system for continuous monitoring surveillance audits further to continue the GDPMD certification.
Swiss Approval International guarantees an accredited certification, giving to Organizations the suitable passport for International market, ensuring with accuracy and independence of principles and rules established by the local and international authorities of GDPMD.