Regulation of Ophthalmic Viscosurgical Devices (OVD) in Thailand

Ophthalmic Viscosurgical Devices

The Ministry of Public Health of Thailand has released standards and specifications for Ophthalmic Viscosurgical Devices (OVD) to ensure that standards in Thailand are consistent with global medical device standards.

The Ministry of Public Health of Thailand recognizes the importance of ensuring that the standards and specifications of Ophthalmic Viscosurgical Devices (OVD) are consistent with global medical device standards. OVD are viscoelastic solutions used in eye surgery. They contain sodium hyaluronate, chondroitin sulfate or hydroxypropyl methylcellulose, and are used to maintain space to protect intra-ocular tissues and manipulate tissue during surgery; however, the products are removed before the surgical process is completed.

The main standards in Thailand for Ophthalmic Viscosurgical Devices are as follows:

  • OVDs are only available for sale to licensed ophthalmologists in a hospital or clinic setting
  • The OVD indication of use must meet international standards such as ISO 15798:2010 Ophthalmic Implants-Ophthalmic viscosurgical devices
  • OVDs must be produced by a manufacturer that has acquired production quality system certification for such products according to international standards such as Good Manufacturing Practice (GMP) and ISO 13485

2018-03-29T06:57:29+08:00 March 27th, 2018|News & Events|

Singapore: QMS transition from GDPMDS to SS 620:2016

SS 620:2016

The new QMS standard in Singapore is called SS 620:2016 – Good Distribution Practice for Medical Devices. The effective implementation date of this standard is from the 9 November 2017 until the 8 November 2020. All companies currently certified to GDPMDS – TS-01 Rev 2.1 have three years to transition to SS 620:2016.

It is mandated by the Health Sciences Authority (HSA) in Singapore that all companies involved in wholesale and/or importation of medical devices must obtain GDPMDS certification. However, there has been a revision recently by SPRING Singapore, in collaboration with the Singapore Manufacturing Federation – Standards Development Organization (SMF-SDO) and HSA.

The new standard is called SS 620:2016 – Good Distribution Practice for Medical Devices. The effective implementation date of this standard is from the 9 November 2017 until the 8 November 2020. All companies currently certified to GDPMDS – TS-01 Rev 2.1 have three years to transition to SS 620:2016. The current standard will still be recognized and audited until the 8 Nov 2020. In order to ensure a full transition to the new standard, certifications starting from 1 Sep 2019 are advised to follow SS 620:2016.

The personnel responsible for QMS should start to revise their Site Master File and existing GDPMDS procedures in accordance with the structure and requirements of the new standard. For more information, you can purchase SS620:2016 here.

Below is a comparison of the framework:

2018-03-29T06:03:47+08:00 March 27th, 2018|News & Events|

Indonesia “120 Working Days” Drug Registration Pathway

120 Working Days

In Indonesia, the ‘120 working days’ registration pathway has been introduced to facilitate the registration of new chemical entities, drug applications, drug indications or dosage regimens that have already been approved in a minimum of 3 (three) reference countries with an established registration system, such as the EU (EMA), UK (MHRA), US (FDA), Canada (Health Canada), and Australia (TGA).

In November 2017, the National Agency of Drug and Food Control (NADFC) of Indonesia officially launched the new version of “The Procedure and Guideline for Drug Registration”. One of the most significant changes was the introduction of a new registration pathway: the “120 Working Days” Drug Registration Pathway. This registration pathway was introduced to facilitate the registration of new chemical entities, drug applications, indications, or dosage regimens that have already been approved in a minimum 3 (three) reference countries with an established registration system such as the EU (EMA), UK (MHRA), US (FDA), Canada (Health Canada), and Australia (TGA).

This “120 Working Days” pathway is similar to the “verification” drug evaluation routes for registering a new therapeutic product in Singapore (HSA). However, Singapore requires at least two reference countries, while Indonesia requires a minimum of three reference countries. Moreover, the Indonesian pathway includes an additional criterion: the drug must have a similar indication(s), dosing regimen(s), target patient(s), and/or direction(s) to the approved drug in other reference countries. Unlike the “120 Working Days” drug registration pathway, a similar process has not been introduced for medical device registration; however, new regulations recently launched by the Indonesia Ministry of Health have streamlined the timelines for medical device registration.

2018-03-29T07:11:21+08:00 March 27th, 2018|News & Events|

Drafted Guideline on Labeling for Medical Devices and In-Vitro Diagnostic (IVD) Medical Devices in the Philippines

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).

Republic Act No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA no: 9711 (FDA Act of 2009), was enacted to establish an effective regulatory system for the authorization, registration and monitoring of health products.

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.

2018-03-29T07:11:58+08:00 March 27th, 2018|News & Events|