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.

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.

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.

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:

a)    Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury
• investigation, replacement, modification or support of the anatomy or of a physiological process,
• supporting or sustaining life
• control of conception
• disinfection of medical devices
• providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;
• and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

To explain further, medical devices are from a simple tongue depressor to a complicated MRI machine. Medical devices also included condoms, cottons, test tubes, etc. In-vitro diagnostic devices or self test tubes are also considered as medical devices.

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://gwhs-stg01.i.gov.ph/~dohgov/licensing

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

If the company complies with the requirements and passed the inspection, a license to operate will be issued. The company is given sixty days to comply with all the deficiencies. Non-compliance will result to temporary stoppage of the selling of medical devices.

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://gwhs-stg01.i.gov.ph/~dohgov/licensing Only complete documents will be accepted during the application.

The application will be reviewed and evaluated if in accordance with the requirements. All complying applications will be issued a certificate of product registration. All non-complying applications will be issued a notice of deficiency. Each company is given a non-extendable ninety (90) days compliance period. All those who will not be able to comply will be disapproved but will be given a period of sixty (60) days to file for re-application and comply with all the deficiencies. In case after this period the application did not satisfactory comply all the requirements, the application will be disapproved and the company needs to file for initial application.

The BHDT is the recommending office for approval of the CPR. All CPRs are forwarded to FDA (BFAD) for approval.

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.

For exempted medical devices, a certificate of listing will be issued prior to the importation of the device.

These new requirement will be coordinated with the Bureau of Customs prior to its implementation.

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.

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.