All local manufacturers, distributors (importers, exporters and wholesalers), traders and re-packers of medical devices, in-vitro medical devices and health-related devices in the Philippines shall comply with the labeling requirements as drafted by the Center for Device Regulation, Radiation Health and Research (CDRRHR).
Rationale:
The Philippines, as a member state in the ASEAN region, is mandated to align and implement the ASEAN Agreement on Medical Device Directives (AMDD) of 2014, to continuously harmonize the technical procedures and requirements applicable to the medical device industry in the ASEAN region, and to address and reduce diversity in the regulations of medical device labeling requirements.
In December 2017, the FDA drafted a guideline on the labeling of medical devices and IVD medical devices, which serves to communicate safety and performance-related information to users and/or patients and to identify devices. This information may appear on the primary and secondary levels of packaging.
General Guidelines:
All local manufacturers, distributors (importers, exporters and wholesalers), traders and re-packers of medical devices, in-vitro medical devices and health-related devices in the Philippines shall comply with the labeling requirements as drafted by the Center for Device Regulation, Radiation Health and Research (CDRRHR).
1. The following details the minimum mandatory information that shall appear in the labeling materials for devices:
- Product Name (Name of Medical Device)
- Brand Name
- Net Content or Pack Size
- Product Code or Reference Number of the device
- Name and Address of MAH
- Name and Address of Manufacturer
- Date of Manufacture
- Registration Number
- Batch Code/Lot Number and/or Batch Number (if any)
- Expiration Date
- Precaution(s), Warning(s) (if applicable)
- Special Storage and/or Handling Conditions
- Sterility
- Method of Sterilization
- Instruction for Use (if applicable)
- MDAE Reporting Statement
- IVD medical device
- Additional and other requirements:
i. The following should be indicated on the label: any indication with regards to the conditions, intended use/purpose; whether the device emits radiation; the details of the nature, type, intensity and distribution of radiation-emitting medical devices
ii. Any residual risk identified in the risk analysis should be reflected as contraindications, precautions or warnings within the labeling.
2.Minimum mandatory requirements for label formatting are as follows:
- The labeling should be written in American English and/or Filipino
- The font size should be adequate and the printing of the labeling materials should ensure legibility
- The color contrast between the labeling and package background should be sufficient so as not to obscure information
- Labeling can be supplemented with drawings and diagrams, if appropriate
3. For products intended to be sold without a product information sheet and unit carton, the minimum mandatory information shall be required to be reflected on the primary label.
4. Where individual packaging of each unit is not practicable, the information should be set out in the leaflet, packaging insert or other media supplied with, or applicable to, one or multiple medical devices.
5. The use of internationally recognized symbols is encouraged provided that medical device safety is not compromised by a lack of understanding on the part of the patient or user. Where the meaning of the symbol is not obvious, e.g. for a lay-user or for a newly introduced symbol, an explanation should be provided.
6. Medical device claims shall be subject to regulatory control of CDRRHR-FDA. As a general rule claimed benefits of a medical device must be supported with substantial evidence and/or by the medical device composition/formulation/component or preparation itself in accordance with the requirements set out in the AMDD.
Transitory:
Once the drafted Administrative Order comes into effect, all labeling for registrable medical devices will need to comply with the new guidelines before the devices can be sold, distributed or marketed in the Philippines. For registered devices currently available in the Philippine market, there will be a one (1) year compliance period once the guidelines come into effect.
This drafted guideline is still subject to review and approval by the Director-General of the Philippine Food and Drug Administration. However, all local manufacturers, distributors (importers, exporters and wholesaler), traders and re-packers of medical devices, in-vitro medical devices and health-related devices in the Philippines should be prepared for this change prior to the guideline’s approval and implementation.
To register your medical device in the Philippines or to know more about our relabling services in the Philippines contact us on sales@andamanmed.com