Medical Device

What will be the requirements for the importation of medical devices once the new regulatory system is implemented?

Submitted by admin on June 23, 2011 - 15:51

Only two documents will be required from the company who will be importing medical devices, the LTO and the CPR. For medical device that is for registration, a special certification will be issued stating that the product to be imported will be issued as a sample only for registration.

Who are the establishments that will be covered by the new medical device regulatory system?

Submitted by admin on June 23, 2011 - 15:50

Manufacturers, importers, wholesalers, exporters and retailers will be required to secure license to operate as medical device establishment. The new guidelines will be published once approved. Refurbishers will also be regulated but in a later time.

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When will be the implementation of the new regulatory system for medical devices?

Submitted by admin on June 23, 2011 - 15:44

The projected date of implementation is third quarter of 2011 considering that the IRR of RA 9711 is approved in 2010. There will be seminars that will be conducted before the implementation of the new regulatory system once the administrative guidelines are approved to guide the medical device industry on the new system of medical device regulation.

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What is the process for licensing of medical device establishment?

Submitted by admin on June 23, 2011 - 15:41

Companies who are selling registrable medical devices should apply for LTO. The requirements for the application of LTO can be downloaded from the DOH website. http://www.doh.gov.ph/licensing

Only complete documents will be accepted during the application and will be scheduled for inspection.

How many days will it take for the processing of the license to operate (LTO)?

Submitted by admin on June 23, 2011 - 15:37

The timeline given for the processing of the LTO is ninety (90) days. This is considering that all the documents submitted are in compliance with the requirements and that the company passed the inspection.

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What is the process of product registration (CPR)?

Submitted by admin on June 23, 2011 - 15:30

Companies with valid license to operate (LTO) as medical device distributor-importer/wholesaler can file for application for product registration. The requirements for the application for CPR can be downloaded from the DOH website. http://www.doh.gov.ph/licensing Only complete documents will be accepted during the application.

How many days will it take for the processing of the certificate of product registration?

Submitted by admin on June 23, 2011 - 15:26

The timeline given for the processing of a certificate of product registration (CPR) is ninety (90) days. This is considering that all the documents submitted are in compliance with the requirements. In cases there are deficiencies issued to the company, the counting of the timeline stops and will resume only upon submission of the compliance documents.

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What are the medical devices presently regulated in the Philippines?

Submitted by admin on June 23, 2011 - 15:24

The BHDT is the technical arm of BFAD by virtue of Administrative Order 2007-0003. The regulated medical devices are based on BFAD’s Memorandum Circular No. 7 dated April 24, 1992. Also for mandatory registration are medical devices that are implantable, invasive and sterile.

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What is a Medical Device?

Submitted by admin on June 23, 2011 - 15:16

Based on the regional and global definition of medical device, it is defined as:

Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

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