65- 9389 9604

   kennar@singnet.com.sg

Chinese Proprietary Medicines (CPM)

Product Registration

Singapore Health Sciences Authorities makes it mandatory for CPMs to be listed with them. For successful approval, requirements such as correct labeling and specifications, valid quality certificates and prior tests conducted on the product must be met.

For CPM dealers, we assist companies in the registration of the products and assist your company in the following scope of activities:

1. Compile the registration dossiers
2. Liaise with principals and ministry to ensure prompt and complete documents for the dossiers
3. Guide and liaise with your principals/manufacturers on the document requirements for local submission
4. Submit completed dossiers online
5. Respond to ministry’s queries including input requests upon screening of the dossiers
6. See the process through till the completion of the registration process of the dossier

 

Good Distribution Practice (GDP)

For companies that import and/or wholesale Chinese propriety medicines, a GDP certification will be required to do business in Singapore.

Good Distribution Practice (GDP) is the implemented standard for ensuring that the quality of medical devices is maintained throughout its distribution journey, enhancing customer satisfaction in supplier-customer relationships. A well-implemented GDP will guarantee that products are consistently stored, transported and handled under suitable conditions, in accordance to the marketing authorization and product specifications. GDP is more than a set of quality manuals. It involves practical procedures, qualified personnel, well-maintained facilities/equipment and consistent maintenance of records and documentation.

We provide full support in developing and implementing an effective quality management system for the distribution of medical devices bringing your company in line with the Good Distribution Practice (GDP).

We assist companies in having standard operating procedures that bring your company’s operations in line with the GDP standards. Through internal audits and management reviews that we conduct, lapses in the processes will be rectified. Our unique templates enable easy recording of necessary data, helping your company address any findings or non-conformities upon a post audit, if any.

We work hand in hand with your company from the beginning till a successful certification is attained, including training your staff in the various aspects of GDP to ensure smooth implementation of standards. Subsequently, we will guide your company to apply the relevant licenses ie importer & wholesaler licenses, Company Registration for e-Services (CRIS) account upon successful certification.