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Frequently Asked Questions

Health Products Regulation

Medical Devices > Good Distribution Practice for Medical Devices (GDPMDS)

1.
What is GDPMDS? Why do we need to be certified to GDPMDS?

GDPMDS refers to Good Distribution Practice for Medical Devices.

The aim of GDPMDS is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution process. The certification to GDPMDS is a mandatory requirement in the application of an Importer's or Wholesaler's Licence.

3.
Who can perform the certification to Good Distribution Practice for Medical Devices (GDPMDS)?

Certification to GDPMDS is to be performed by independent third party certification bodies, accredited by the Singapore Accreditation Council.

You may access the Singapore Accreditation Council website for the list of certification bodies that are accredited for GDPMDS.

4.
We import medical devices solely for re-export out of Singapore. Do we still need to be certified to Good Distribution Practice for Medical Devices (GDPMDS)?

The activities of importing and exporting medical devices require licensing by HSA, namely:

  • Importer's licence - A company importing medical devices into Singapore is required to hold an importer's licence.
  • Wholesaler's licence - A company supplying medical devices by wholesale in Singapore or exporting medical devices out of Singapore is required to hold a wholesaler's licence.

Companies that import medical devices solely for re-export out of Singapore can seek exemption from certifiication to GDPMDS. A declaration has to be submitted as part of the importer's and wholesaler's licence applications. The declaration is accessible as part of GN-02 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices. Please go to the regulatory guidances page for more information. 

In addition, medical devices that are imported solely for the purpose of re-exportation, have to be exempted from product registration through the authorisation route for import for re-export, GN-28. Please go to the regulatory guidances page for more information.

 

5.
Do we have to write complicated procedures and workflows in order to meet the requirements of Good Distribution Practice for Medical Devices (GDPMDS)?

The aim of Good Distribution Practice for Medical Devices (GDPMDS) certification is to verify that dealers of medical device have systems in place to ensure that quality of medical devices is maintained throughout the distribution chain. Companies are advised to implement systems that can be applied for the company and to keep their system processes simple. Complicated procedures and workflows are not required for GDPMDS.

6.
Do we need to engage consultants to prepare for the Good Distribution Practice for Medical Devices (GDPMDS)?

HSA does not endorse nor recommend any consultant for the preparation for GDPMDS. To facilitate your preparation for GDPMDS, we have published the following guidances:

Systems of stock handling, storage and distribution are already in place in most companies. Companies will find that with some small effort and understanding of the requirements, they will be able to implement simple procedures and processes to meet the GDPMDS requirements.

7.
Does my overseas manufacturer or distributor need to be certified to Good Distribution Practice for Medical Devices (GDPMDS)?

Overseas manufacturers or distributors do not need to be certified to GDPMDS.  Only the local companies need to apply for an importer's and/or wholesaler's licence(s), and therefore only the local company need the GDPMDS certification.

8.
My company is certified to ISO 9001:2000, do I still need to be certified to GDPMDS?

Although some of the requirements of GDPMDS are similar to ISO 9001:2000 requirements, the scope of ISO 9001:2000 is not sufficient to meet the requirements for GDPMDS.

Companies that are certified to ISO 9001 by one of the accredited certification bodies may arrange with the certification body to expand the next ISO 9001 audit to meet GDPMDS requirements.

9.
My company manufactures medical devices in Singapore, as a manufacturer, we are certified to ISO 13485:2003. We also supply medical devices in Singapore. Do we need to obtain certification to GDPMDS?

Local manufacturers are exempted from certification to GDPMDS in their applications for importer's and/or wholesaler's licence(s), if the scope of their ISO 13485:2003 certification covers storage and distribution of medical devices. If they wish to apply for the importer's or wholesaler's licence/s, they can submit the ISO 13485:2003 certificate in place of the GDPMDS certificate.

10.
My parent company overseas is certified to ISO 9001 or ISO 13485. Although the local operation in Singapore is not part of the certification, we are following all the procedures and process. Do I still need to be certified to GDPMDS?

As the overseas parent company's certification to ISO 9001 or ISO 13485 does not cover the local operation in Singapore, the local operation does not have an “audited” system in place. Hence, the local company has to be certified to GDPMDS. However, the overseas parent company certified to ISO 13485 could consider including the Singapore site as one of the facilities under the scope of their ISO 13485 certificate and to cover the storage and distribution of the medical devices in Singapore. This can then be submitted in place of the GDPMDS certificate in the local operation's application for the licence/s.

12.
My company has multiple warehouse locations that are used for storage and distribution of medical devices, would all the different sites need to be audited?

For companies with multiple sites, if all the sites use the same procedures, processes and systems, the certification bodies will use a formula to determine the number of sites to be audited.

In the event where each of the site uses different procedures or implements different systems, it is then necessary for these sites to be audited separately.

13.
What are the charges for certification to Good Distribution Practice for Medical Devices (GDPMDS)?


The charges will vary between the different Certification Bodies. Companies that seek certification should contact these Certification Bodies to find out their charging scheme. You may wish to compare quotations from the various certification bodies.

14.
We are a third party logistics company. We provide warehousing and distribution service to a few different medical device dealers. Do we have to be audited for each of the dealers that we provide service to?

Typically, third party logistic companies do not need to be certified to GDPMDS. But as their facilities are used to store medical devices for their customers, the third party logistic companies will be audited as part of the audit on their customers. Hence, if they have 10 customers, potentially, the third party logistic companies will be audited 10 times a year by the various certification bodies.

It may be advisable for third party logistic companies that serve multiple medical device dealers to be GDPMDS certified independently. Their customers may then make reference to their certificate and the third party logistic companies will only need to be audited once per year by its own certification body.

15.
What is Site Master File (SMF)?

The Site Master File is a document prepared by the company. It contains specific and factual Good Distribution Practice for Medical Devices (GDPMDS) information about the storage, distribution and delivery operations carried out at the named site.  The SMF only needs to describe the particular activities, e.g. storage, that are carried out at the site.

Importers and Wholesalers of medical devices are required to prepare the Site Master File for their certification to GDPMDS. The Site Master File need not be submitted to HSA.

Please refer to GN-03 Guidance on Preparation of a Site Master File for Licensing for more information.

16.
Does my overseas manufacturer or distributor need to prepare a site master file?


Overseas manufacturers or distributors do not need to prepare a site master file. For the purpose of Good Distribution Practice for Medical Devices (GDPMDS) certification in Singapore, only the local company would need to prepare a site master file that details their local operations and facilities.

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